Reenvisioning Clinical Science: Unifying the Discipline to Improve the Public Health
Open accessAbstract
We present a vision of clinical science, based on a conceptual framework of intervention development endorsed by the Delaware Project. This framework is grounded in an updated stage model that incorporates basic science questions of mechanisms into every stage of clinical science research. The vision presented is intended to unify various aspects of clinical science toward the common goal of developing maximally potent and implementable interventions, while unveiling new avenues of science in which basic and applied goals are of equally high importance. Training in this integrated, translational model may help students learn how to conduct research in every domain of clinical science and at each stage of intervention development. This vision aims to propel the field to fulfill the public health goal of producing implementable and effective treatment and prevention interventions.
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- Premisecitation
Multiple factors converge to create the science-to-service gap, also called the implementation cliff.
“Several factors converge to create this widely acknowledged science-to-service gap, or what Weisz et al. (Weisz, Jensen-Doss, & Hawley, 2006; Weisz, Ng, & Bearman, 2014) call the implementation cliff.”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Weisz, Jensen-Doss, & Hawley, 2006
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- cites Weisz, Ng, & Bearman, 2014
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- Interpretationreasoning
Without a better understanding of how interventions work, adapting interventions, such as reducing dose, may remove their original efficacy.
“In the absence of better understanding of how interventions work, efforts to adapt interventions (e.g., dose reduction), a common practice in community settings, may render the interventions devoid of their original efficacy.”
Quote in the paperSubstantial claim - Premisecitation
A computerized attention modification program directly targets cognitive biases operating in the most prevalent mood disorders.
“Another example is the computerized attention modification program that directly targets cognitive biases operating in the most prevalent mood disorders (Amir & Taylor, 2012).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Amir & Taylor, 2012
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- Premisecitation
A positive efficacy study does not automatically or usually lead to a positive effectiveness study.
“It is not reasonable to expect that a positive efficacy study will automatically or even usually lead to a positive effectiveness study (Flay, 1986).”
- Also stated in: § Concluding Remarks · hedged
“They need to expect that successful research setting–based efficacy trials are not likely to directly result in successful effectiveness trials”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Flay, 1986
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- Also stated in: § Concluding Remarks · hedged
- Interpretationreasoning
For an intervention to be tested for efficacy in a community setting with community providers, it will likely need further development or adaptation.
“For such testing to occur, the intervention will likely need to be further developed or “adapted” for community providers.”
Quote in the paperSubstantial claim
- Interpretationreasoning
Moving directly from Stage II to Stage III is not a typical path in the stage model.
“Immediately and directly proceeding from Stage II to Stage III is not a typical path within the stage model.”
Quote in the paperNot a substantial claim - Interpretationreasoning
Understanding change mechanisms is often critical for developing the most effective interventions that can be scaled up and trimmed down.
“We argue that an understanding of change mechanisms is often critical for developing the most effective interventions that can be scaled up and trimmed down.”
Quote in the paperNot a substantial claim - Interpretationreasoning
Adapting an intervention in response to practical constraints is inherently risky because it may or may not retain the elements that make it work.
“Adapting the intervention in response to practical constraints is an inherently risky endeavor: The intervention may or may not retain the elements that make it work.”
Quote in the paperSubstantial claim - Premisecitation
Community providers have lower motivation and comfort with empirically supported treatments than research therapists do.
“Moreover, community providers’ motivation and comfort level with empirically supported treatments is lower than that of research therapists (Stewart, Chambless, & Baron, 2012).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Stewart, Chambless, & Baron, 2012
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- Premisecitation
Community practitioners often modify interventions, including in effectiveness studies of science-based interventions.
“Often, community practitioners modify the intervention, including those participating in effectiveness studies of science-based interventions (Stewart, Stirman, & Chambless, 2012).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Stewart, Stirman, & Chambless, 2012
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- Interpretationreasoning
After positive Stage II results, additional community-friendly Stage I work is usually needed to prepare the intervention for a Stage III trial.
“If positive results have been obtained from a Stage II study, usually additional community-friendly Stage I work is needed to make the intervention ready for a Stage III trial.”
Quote in the paperSubstantial claim- Rests on an assumption: Complex treatments delivered with high fidelity in research settings by research therapists tend to lose strength when delivered in community settings by community providers.
- Premisecitation
Only a small fraction of clinicians who routinely provide CBT deliver it with adequate fidelity.
“To wit, only a small fraction of clinicians who routinely provide interventions such as cognitive behavioral therapy (CBT) are able to do so with adequate fidelity (Beidas & Kendall, 2010; Olmstead, Abraham, Martino, & Roman, 2012).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Beidas & Kendall, 2010
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- cites Olmstead, Abraham, Martino, & Roman, 2012
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- Interpretationnone given
Complex interventions delivered with high fidelity by research providers in research settings tend to weaken when implemented by community providers in community settings.
“As noted, complex interventions administered with a high degree of fidelity in research settings with research providers seem destined to weaken when implemented in community settings with community providers.”
Quote in the paperNot a substantial claim - Premisecitation
The implementation cliff can be traced in part to the drop in effect size seen in many effectiveness trials.
“For one, we can trace the implementation cliff back to the effect size drop evident in many effectiveness trials (Curtis, Ronan, & Borduin, 2004; Henggeler, 2004; Miller, 2005; Weisz, Weiss, & Donenberg, 1992).”
Quote in the paperSubstantial claim0 of 3 sources checked- cites Curtis, Ronan, & Borduin, 2004
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- cites Henggeler, 2004
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- cites Miller, 2005
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- Premisecitation
Treatment fidelity is a major factor that can explain the drop in effect size.
“A major factor that can explain this drop in effect size is treatment fidelity (also known as treatment integrity), which refers to the implementation of an intervention in a manner consistent with principles outlined in an established manual (Henggeler, 2011; Perepletchikova, Treat, & Kazdin, 2007).”
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- cites Perepletchikova, Treat, & Kazdin, 2007
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- Premisereasoning
Community therapists lack an incentive system similar to that for research therapists.
“There is no similar incentive system for community therapists.”
Quote in the paperSubstantial claim - Interpretationnone given
It is possible to develop highly potent, implementable interventions without understanding mechanisms of change.
“It is entirely possible to develop highly potent, implementable interventions without understanding mechanisms of change.”
Quote in the paperNot a substantial claim - Interpretationcitation
Understanding mechanisms can guide the enhancement and simplification of interventions.
“First, understanding mechanisms can guide the enhancement and simplification of interventions (Kazdin & Nock, 2003).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Kazdin & Nock, 2003
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- Premisecitation
Many efficacious behavioral interventions do not proceed through the pipeline to implementation.
“This strategy is particularly puzzling in light of the fact that so many efficacious behavioral interventions do not make their way down the pipeline through implementation (Carroll & Rounsaville, 2003, 2007; Craske, Roy-Byrne, et al., 2009).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Carroll & Rounsaville, 2003, 2007
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- cites Craske, Roy-Byrne, et al., 2009
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- Interpretationreasoning
Practical alteration of evidence-based interventions could diminish or eliminate their potency.
“Whether done by clinicians attempting to meet real-world demands or by scientists lacking evidence of the intervention’s mechanism of action, practical alteration of evidenced-based interventions could very well diminish or eliminate the potency of the (no-longer-science-based) interventions.”
Quote in the paperSubstantial claim - Interpretationreasoning
If we understood how and why an intervention works, we would be better positioned to emphasize what is potent.
“If we understood how and why an intervention is working, we are better positioned to emphasize what is potent.”
Quote in the paperNot a substantial claim - Interpretationreasoning
When a Stage II study is proposed instead of a Stage III study, it is generally because the intervention is not ready for community testing.
“Generally, when Stage II (rather than Stage III) is proposed, it is because the intervention is not ready to be tested in the community”
Quote in the paperNot a substantial claim - Interpretationreasoning
Skipping Stage III and moving from Stage II to Stage IV is not a typical path in the stage model.
“Skipping Stage III and proceeding from Stage II to Stage IV is not a typical path within the stage model.”
Quote in the paperNot a substantial claim - Premisecitation
The infrastructure of existing delivery systems may be too weak to provide the complex, high-quality empirically supported therapies used in efficacy studies.
“The infrastructure of existing delivery systems may be too weak to provide the complex, albeit high-quality empirically supported therapies practiced in efficacy studies (McLellan & Meyers, 2004).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites McLellan & Meyers, 2004
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- Premisecitation
Changes to interventions are often made with good intentions and necessity but are frequently based on clinical intuition, experience, or preferences rather than science.
“Changes to interventions are made with good intentions, often due to necessity (e.g., insurers’ demands), and they are frequently based on clinical intuition, clinical experience, or clinician or patient preferences, but not on science (Lilienfeld et al., 2013).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Lilienfeld et al., 2013
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- Premisecitation
Advances in understanding neurobiological, behavioral, and psychological mechanisms of disorders are not sufficiently linked to mechanisms of action in intervention development research.
“Despite substantial advances in the understanding of neurobiological, behavioral, and psychological mechanisms of disorders, these understandings are not sufficiently linked to mechanisms of action in intervention development research (Kazdin, 2007; Murphy, Cooper, Hollon, & Fairburn, 2009).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Kazdin, 2007
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- cites Murphy, Cooper, Hollon, & Fairburn, 2009
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- Interpretationreasoning
Knowing principles could clarify when it is important to intervene in one particular way or in any number of ways as long as the intervention is faithful to the mechanism of action.
“Knowing principles could also help clarify when it is important to intervene in one particular way, or to intervene in any number of ways, as long as the intervention is faithful to the mechanism of action.”
Quote in the paperNot a substantial claim - Premisecitation
Workshops and lectures by themselves produce little substantive change in clinician behavior.
“This may reflect the insufficiency of commonly used training and dissemination methods such as workshops and lectures, which by themselves effect little substantive change in clinician behavior (Miller, Yahne, Moyers, Martinez, & Pirritano, 2004; Sholomskas et al., 2005).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Miller, Yahne, Moyers, Martinez, & Pirritano, 2004
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- cites Sholomskas et al., 2005
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- Premisecitation
In one directly observed study, CBT concepts were mentioned in fewer than 5% of sessions.
“For instance, in one study CBT concepts were mentioned in fewer than 5% of sessions based on direct observation (Santa Ana, Martino, Ball, Nich, & Carroll, 2008).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Santa Ana, Martino, Ball, Nich, & Carroll, 2008
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- Premisereasoning
Attempts to solve the science-practice gap by changing the service delivery system have encountered formidable barriers.
“Suggestions to solve the science-practice gap by changing the service delivery system have encountered formidable barriers.”
Quote in the paperSubstantial claim - Premisecitation
A tighter link between basic and applied clinical science is missing.
“On the other side of the translation-implementation continuum (Shoham et al., 2014), we are missing a tighter link between basic and applied clinical science (Onken & Blaine, 1997; Onken & Bootzin, 1998).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Onken & Blaine, 1997
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- cites Onken & Bootzin, 1998
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- Premisenone given
Many investigators move directly from traditional efficacy studies with research therapists to effectiveness studies without first conducting a controlled efficacy study with community therapists to ensure fidelity.
“Despite this gap, many investigators still move directly from traditional efficacy studies (with research therapists) to effectiveness studies, without first conducting an efficacy (i.e., controlled) study with community therapists to ensure that the intervention being studied is implementable with fidelity when administered by community practitioners.”
Quote in the paperSubstantial claim - Premisenone given
Decades of research with little attention to change mechanisms have produced very few interventions that are efficacious, effective, and implementable.
“Decades of research with little attention to change mechanisms have produced very few interventions that are efficacious, effective, and implementable.”
Quote in the paperNot a substantial claim - Interpretationreasoning
Before an intervention is tested for efficacy in a community setting, it will likely need further development or adaptation for community providers.
“Of course, prior to this testing the intervention will likely need to be further developed or adapted (i.e., in Stage I) for community providers.”
Quote in the paperSubstantial claim- Rests on an assumption: Complex treatments delivered with high fidelity in research settings by research therapists tend to lose strength when delivered in community settings by community providers.
- Interpretationreasoning
Proceeding from Stage II to an effectiveness study without validated measures for training community providers and ensuring fidelity increases the chance that the effectiveness trial will fail.
“Moving to an effectiveness study from Stage II, without validated measures to train community providers and ensure fidelity, increases the likelihood of a failed effectiveness trial.”
Quote in the paperSubstantial claim- Rests on an assumption: Complex treatments delivered with high fidelity in research settings by research therapists tend to lose strength when delivered in community settings by community providers.
- Premisenone given
Even documented acquisition of fidelity skills under close supervision does not guarantee that fidelity will be maintained after supervision ends.
“Furthermore, even documented acquisition of fidelity skills under close supervision does not guarantee continued, postsupervision fidelity maintenance.”
Quote in the paperSubstantial claim - Premisecitation
Successful implementation requires a sustained, multilevel approach in which multiple barriers are addressed simultaneously.
“Any one of these systemic barriers could be difficult to change, and a synthesis of the literature suggests that successful implementation necessitates a sustained, multilevel approach (Damschroder et al., 2009; Fairburn & Wilson, 2013; Fixsen et al., 2005), requiring that multiple barriers be addressed simultaneously for implementation to be successful.”
Quote in the paperSubstantial claim0 of 3 sources checked- cites Damschroder et al., 2009
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- cites Fairburn & Wilson, 2013
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- cites Fixsen et al., 2005
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- Premisecitation
With an understanding of mechanisms, Otto et al. created an ultra-brief treatment for panic disorder.
“For example, with an understanding of mechanisms, Otto et al. (2012) were able to create an ultra-brief treatment for panic disorder.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Otto et al. (2012)
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- Premisereasoning
Basic science can be incorporated into all other stages of intervention development.
“Basic science can also be incorporated into all other stages of intervention development.”
Quote in the paperSubstantial claim- Rests on an assumption: Basic science plays a major role in intervention development.
- Interpretationnone given
Efficacy and effectiveness research that is separated from the science of how and why interventions work can produce interventions that work and are sometimes good enough.
“Efficacy and effectiveness research divorced from the science of how and why interventions work can yield interventions that work, and in some cases that can be good enough.”
Quote in the paperNot a substantial claim - Interpretationreasoning
Stage III is intended to maximize the chances of a successful Stage IV study.
“Stage III is meant to maximize the chances of a successful Stage IV study.”
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- May combine two claims. 24
- Classified as probably not a substantial claim. 36
May combine two claims.
PremisecitationEfficacious behavioral treatments exist for many mental disorders, but patients seeking treatment in community settings rarely receive them.
“Although efficacious behavioral treatments for many mental disorders exist, patients who seek treatment in community settings rarely receive them (Institute of Medicine, 2006).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Institute of Medicine, 2006
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Premisenone givenMany clinical scientists are not yet taking the approach of studying change mechanisms in intervention development research.
“Despite these frequent calls for studying change mechanisms in intervention development research, many clinical scientists are not yet taking this approach.”
Quote in the paperNot a substantial claimMay combine two claims.
Premisenone givenResearch therapists tend to be committed to the therapy they administer and to the research process, and they are directly incentivized to implement treatments with skill and fidelity.
“Research therapists tend to be committed to the therapy they are administering and to the research process, and they are directly incentivized to implement treatments with skill and fidelity.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationIn a study of clinical psychologists treating posttraumatic stress disorder, 17% reported using exposure therapy and 72% reported discomfort with it.
“For example, in a study of clinical psychologists’ use of exposure therapy for posttraumatic stress disorder, only 17% of therapists reported using the evidence-based treatment, and 72% reported a lack of comfort with exposure therapy (Becker, Zayfert, & Anderson, 2004).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Becker, Zayfert, & Anderson, 2004
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InterpretationreasoningNo party takes charge of ensuring implementability, so the cycle continues.
“As it turns out, nobody takes charge, and the cycle continues.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationEmpirically supported therapies are not always preferentially reimbursed, while some ineffective or harmful interventions continue to be reimbursed.
“Another particularly unfortunate barrier is that empirically supported therapies are not always preferentially reimbursed, whereas some interventions that have been shown to be ineffective or worse (e.g., repeated inpatient detoxification without aftercare) continue to be reimbursed (Humphreys & McLellan, 2012).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Humphreys & McLellan, 2012
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InterpretationreasoningThe development of potent and implementable behavioral interventions could be revolutionized if the field unified around fundamental mechanisms of behavior change and all clinical scientists were trained to address mechanisms at every stage of intervention development.
“We suggest that the development of potent and implementable behavioral interventions could be revolutionized if the field were unified around fundamental mechanisms of behavior change and if all types of clinical scientists were trained to address mechanism of action of behavioral interventions at every stage of the intervention development process.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationImplementing such treatments may require fundamental changes in training and supervision of community clinicians, smaller patient loads, and more time per patient.
“For example, implementation of such treatments may require fundamental changes in the training and ongoing supervision of community-based clinicians (Carroll & Rounsaville, 2007), smaller numbers of patients assigned to each clinician, and increased time allotted per patient.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Carroll & Rounsaville, 2007
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InterpretationreasoningWhen clinical scientists uncover essential mechanisms of action, they may be able to package an intervention in a highly implementable way.
“On the other hand, when clinical scientists uncover essential mechanisms of action, they may be able to package the intervention in a way that is highly implementable.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationDirect supervision of community clinicians' fidelity and skill in delivering evidence-based practice is rarely provided and is not reimbursed or incentivized.
“Direct supervision, via review of clinicians’ levels of fidelity and skill in delivering evidence-based practice, is rarely provided in community-based settings and is also not reimbursed or otherwise incentivized (Olmstead et al., 2012; Schoenwald, Mehta, Frazier, & Shernoff, 2013).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Olmstead et al., 2012
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- cites Schoenwald, Mehta, Frazier, & Shernoff, 2013
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PremisecitationSuch modifications typically involve fewer sessions, group rather than individual format, and other shortcuts that could reduce potency.
“Such alterations typically involve delivering the intervention in far fewer sessions, in group versus individual format, and other shortcuts that could diminish potency.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Stewart, Stirman, & Chambless, 2012
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Interpretationnone givenStudents need an integrative vision of the field, to see themselves as part of it, and to know how to interact with scientists in other parts of clinical science for the field to flourish long term and achieve its potential for public health impact.
“However, the need for students to acquire a more integrative vision of the entire field, to see themselves as part of it, and to understand how to interact with scientists in other parts of the clinical science system is critical for clinical science to flourish in the long term, and to achieve its rich potential for exerting a positive impact on public health.”
Quote in the paperNot a substantial claim- Rests on an assumption: Most clinical researchers were not trained in an integrative outlook and are too embedded in current clinical research pressures to change quickly.
May combine two claims.
Premisenone givenEfficacy research values internal validity, while effectiveness research prioritizes external validity at the expense of internal validity, producing a disconnect.
“There is a clear disconnect between efficacy research that values internal validity and effectiveness research that prioritizes external validity at the expense of internal validity.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
PremisecitationA need has been identified for research that falls between traditional efficacy and effectiveness research.
“a need has been identified for research between traditional efficacy and effectiveness research (Carroll & Rounsaville, 2007; Weisz et al., 2013).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites Carroll & Rounsaville, 2007
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- cites Weisz et al., 2013
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InterpretationreasoningResearchers across the spectrum from basic clinical science to applied intervention development can help each other and themselves by opening new research avenues and asking new questions while fostering public health.
“Researchers from the most basic realm of clinical science to the most applied realm of intervention development not only can help each other, but also can help themselves by opening up new avenues of research pursuits, and asking and answering new research questions—all while fostering the public health.”
Quote in the paperNot a substantial claimMay combine two claims.
InterpretationreasoningA successful Stage III trial demonstrates that an intervention can be delivered faithfully in the community and that it retains efficacy.
“A successful Stage III trial shows that it is possible to deliver faithfully an intervention in the community, and that the intervention retains efficacy.”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationreasoningUnderstanding mechanisms could clarify scientifically based principles of interventions, and imparting these principles may help practitioners deliver with higher fidelity than strict manual adherence.
“Understanding mechanism could help to clarify scientifically based principles of interventions, and imparting these principles may help practitioners deliver interventions with a higher level of fidelity than requiring a strict adherence to intervention manuals.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone givenNumerous calls have been made for research on mechanisms of change.
“There have been numerous calls for research on mechanisms of change.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
Interpretationnone givenA major reason for the relative lack of attention to mechanisms in prior research may be that areas of clinical science are largely disconnected.
“We suggest that a major reason for the relative lack of attention to mechanisms in prior research may be an unfortunate consequence of largely disconnected areas of clinical science.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningBasic science questions and research paradigms are integral to the entire behavioral intervention development process, not limited to research before intervention development.
“Hence, basic science questions and relevant research paradigms should not be limited to research that occurs prior to intervention development; they are integral to the entire behavioral intervention development process.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisereasoningNot all dissemination and implementation research examines the intervention itself, except as something to be adopted by the system.
“Although relevant to intervention development, not all D&I research looks at the intervention per se, except as something to be adopted by the system.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationA recent announcement called for research on putative mechanisms of action of behavioral interventions with the ultimate goal of simplifying and creating more implementable interventions.
“Indeed, one recent announcement, “Use-Oriented Basic Research: Change Mechanisms of Behavioral Social Interventions” (http://grants.nih.gov/grants/guide/pa-files/PA-12-119.html), called for research to study putative mechanisms of action of behavioral, with the ultimate goal of simplifying and creating more implementable interventions.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites http://grants.nih.gov/grants/guide/pa-files/PA-12-119.html
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Premisenone givenDissemination and implementation research focuses at least as much, if not more, on the service delivery system as on the intervention itself.
“Generally speaking, dissemination and implementation (D&I) research focuses at least as much if not more on the service delivery system as opposed to the intervention itself.”
Quote in the paperNot a substantial claimMay combine two claims.
Premisenone givenClinical scientists usually do not convey modifications to interventions and often lack tools to retain effective ingredients while guiding adaptation.
“Unfortunately, clinical scientists are not usually the conveyers of such modifications, nor do they always have the tools necessary to retain effective intervention ingredients while guiding adaptation efforts.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
InterpretationreasoningSimplifying interventions could help with training, cost, and transportability.
“Simplification of interventions could help with training, cost, and transportability.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
Interpretationnone givenThe implementation problems fall between scientific cracks at a meta-level.
“A meta-level problem is that these problems fall between scientific cracks.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
Interpretationnone givenQuestions about mechanisms of disorders and mechanisms of change are conceptually similar to questions in basic behavioral science.
“Questions regarding mechanisms of disorders and mechanisms of change are conceptually similar to questions asked within basic behavioral science.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
InterpretationreasoningInterventions at Stage V are not exempt from the requirement to study mechanisms; understanding how implementation strategies work is important.
“This does not imply, however, that interventions at this stage are exempt from the desiderata regarding mechanism that are discussed in previous sections: It is important to understand how implementation strategies work.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.
Interpretationnone givenA common language fosters a progressive discipline and creates the groundwork to solve public health problems.
“A common language fosters a progressive discipline, creating the groundwork to solve public health problems.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable). May combine two claims.
InterpretationreasoningThis common language facilitates research grant proposal writing and review, leading to a more coherent, efficient, and progressive science.
“This common language facilitates research grant proposal writing and review, ultimately leading to a more coherent, efficient, and progressive science.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
InterpretationreasoningTraining students to use the stage model as a heuristic can help achieve the goals of underscoring interconnectedness, awareness of mechanisms, defining essential aspects, promoting a common language, and emphasizing full development of potent interventions through implementation.
“Training students to use the stage model as a heuristic can help to foster all of these goals.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningThe vision requires clinical scientists and their students to understand that intervention development is far from complete when an intervention shows efficacy in Stage II.
“The vision presented here demands that clinical scientists understand and train their students to understand that intervention development is far from complete when an intervention shows efficacy in Stage II.”
Quote in the paperNot a substantial claim- Rests on an assumption: Complex treatments delivered with high fidelity in research settings by research therapists tend to lose strength when delivered in community settings by community providers.
Probably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningA new vision for clinical science is equivalent to a new vision for intervention development because both ultimately aim at interventions that promote physical and mental health.
“A new vision for clinical science is, in a sense, equivalent to a new vision for intervention development, in that the ultimate goal of both is interventions that promote the physical and mental health of individuals.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable). May combine two claims.
InterpretationreasoningDefining a stage between efficacy and effectiveness draws attention to the importance of that stage and clarifies the use of the terms efficacy and effectiveness.
“Moreover, defining a stage in between efficacy and effectiveness, where interventions can be tested with high internal validity, with research therapists in research settings, draws attention to the importance of this stage of intervention development, and also provides more clarity when the words efficacy and effectiveness are used.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
PremisereasoningDefining treatment generation and refinement helped legitimize this necessary part of behavioral treatment research.
“For example, defining treatment generation and refinement helped to legitimize this necessary part of behavioral treatment research.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
InterpretationreasoningBasic science is an integral part of the goal of interventions that promote health because basic and all types of applied clinical scientists are necessary to fully achieve it.
“Although the ultimate goal may be applied, basic science is an integral part of that goal because basic and all types of applied clinical scientists are necessary to fully achieve it.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
Premisenone givenBasic science can precede and provide the basis for generating a new intervention or modifying an existing one.
“Stage 0 can precede and provide the basis for the generation of a new intervention, or the modification of an existing one.”
Quote in the paperNot a substantial claim- Rests on an assumption: Basic science plays a major role in intervention development.
Probably not a substantial claim: may not pass S2 (checkable), S4 (based).
InterpretationreasoningWith a common language, a defined Stage III, and a mind-set that values basic science and implementability, the field can replace unproductive cycles of efficacy and effectiveness trials with a path toward implementing effective interventions.
“With a common language, the (oftentimes) missing link of Stage III defined, and a mind-set that includes an appreciation of basic science and implementability within intervention development, we expect to replace the merry-go-round of efficacy and effectiveness trials that go nowhere with a map that leads toward implementation of effective interventions.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable). May combine two claims.
InterpretationreasoningIf basic science can inform and be informed by applied clinical science, the field can expand, help solve public health problems, and gain recognition for doing so.
“Basic science divorced from applied science can yield fascinating findings, but if basic science can inform and be informed by applied clinical science, the field can expand and can help solve public health problems, and be noticed for doing so.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
Interpretationnone givenTraining the next generation of clinical scientists to embrace this new vision could lead to a new generation of powerful and implementable interventions for public health.
“Training the next generation of clinical scientists to embrace this new vision could mean a new generation of powerful and implementable interventions for the public health.”
Quote in the paperNot a substantial claimMay combine two claims.
InterpretationcitationIncorporating basic science into Stage IV may be more complex than into Stages I to III, but methods may exist for doing so.
“It may be more complex to incorporate Stage 0 (basic science) into Stage IV than into Stages I to III, but there may be methods for doing so (Collins, Dziak, & Li, 2009; Doss & Atkins, 2006).”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites Collins, Dziak, & Li, 2009
Not checked in the free run.
- cites Doss & Atkins, 2006
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.
Interpretationnone givenUnderstanding the basic principles of behavior change for an intervention will fuel every stage of intervention development and help create more potent and implementable interventions.
“As discussed earlier, we believe that understanding the basic principles of behavior change for an intervention will fuel every stage of intervention development and will facilitate the creation of ever more potent and implementable interventions.”
Quote in the paperNot a substantial claim- Rests on an assumption: Basic science plays a major role in intervention development.
Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.
InterpretationreasoningQuestions will still arise if the field is integrated, but the science will be better positioned to progress coherently.
“Questions will still arise if the field is integrated, but the science will be better positioned to coherently progress.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).
InterpretationreasoningA Stage II study can provide an ideal opportunity to experimentally manipulate and test mechanisms.
“Indeed, a Stage II study can provide an ideal opportunity to experimentally manipulate and test mechanisms.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningDefining the stages creates a common language for discussing behavioral intervention development across clinical, academic, and research settings.
“Finally, defining the stages creates a common language through which behavioral intervention development can be discussed across clinical, academic, and research settings.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningWithout understanding mechanisms, many questions can arise when clinical trials fail and even when they succeed.
“On the other hand, without an understanding of mechanisms, endless questions can arise when clinical trials fail (e.g., questions about appropriateness of design, delivery, fidelity, population, providers, etc.) and even when they succeed”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningDefining stages of behavioral intervention development highlights the value and frequent necessity of a particular type of research endeavor.
“defining stages of behavioral intervention development highlights the value and frequent necessity of a particular type of research endeavor.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
Interpretationnone givenIf an intervention is not implementable in the community, more work is needed, even if that work shows there is currently no way to make it more implementable.
“If an intervention is not implementable in the community, there is more work to be done—even if that work ends up showing that there is no conceivable way currently to change the intervention into a more implementable form.”
Quote in the paperNot a substantial claim- Rests on an assumption: Complex treatments delivered with high fidelity in research settings by research therapists tend to lose strength when delivered in community settings by community providers.
Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.
InterpretationreasoningEven though stages do not always occur in a prescribed order and it is not always necessary to progress through every stage, defining the stages facilitates communication and clarifies research activities and next steps.
“So even though the stages of behavioral intervention development do not always—or even usually—occur in a prescribed order, and even though it is not always—or even usually—necessary to progress through every stage, it facilitates communication and helps clarify research activities and necessary next steps when the stages of intervention development research are defined.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
Complex treatments delivered with high fidelity in research settings by research therapists tend to lose strength when delivered in community settings by community providers.
“Complex treatments administered with a high degree of fidelity in research settings with research therapists seem destined to weaken when implemented in community settings with community providers.”
The paper relies on this without support.
Most clinical researchers were not trained in an integrative outlook and are too embedded in current clinical research pressures to change quickly.
“Realistically, the large majority of clinical researchers, sympathetic as they may be to this sort of integrative vision, were not trained in this kind of outlook and are far too ensconced in the intense pressure of contemporary clinical research to change rapidly.”
The paper relies on this without support.
Clinical science training currently produces excellent basic scientists, intervention developers and testers, effectiveness researchers, and implementation scientists.
“Moreover, clinical science training now produces excellent basic scientists, intervention generators and testers, effectiveness researchers, and implementation scientists.”
The paper relies on this without support.
It is generally considered necessary to demonstrate that an intervention is effective before moving to implementation and dissemination in real-world settings.
“It is generally considered necessary to show that an intervention is effective before proceeding to implementation and dissemination in the real world.”
The paper relies on this without support.
Basic science plays a major role in intervention development.
“Basic science, considered to be Stage 0, plays a major role in intervention development.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
It is recommended to conduct a pilot trial before the real RCT to assess feasibility and improve the quality of the real RCT.
“It is recommended to conduct a pilot trial before the real RCT to assess feasibility and improve the quality of the real RCT [20–22].”
From A pilot randomised trial comparing a mindfulness-based stress reduction course, a locally-developed stress reduction intervention and a waiting list control group in a real-life municipal health care setting (2020) · cites this paper as [21]
The NIH Stage Model sections on Stage I and Stage II describe pilot testing and say that proceeding to later testing presumes promising feasibility data. They do not specifically recommend a pilot trial to improve the quality of a subsequent RCT; Stage II may use an RCT or another design. (LLM, conf=0.86)
Experimental — accuracy not yet measuredCommunity healthcare providers face practical constraints and limited resources, leading them to adapt treatment manuals or broaden the population receiving the intervention.
“Conversely, community healthcare providers face real-world practical constraints and limited resources, which means they adapt treatment manuals to their service needs or broaden the population to which the intervention is applied (Onken et al. 2014).”
From The Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Real-World Healthcare Services (2020) · cites this paper as Onken et al. 2014
As a program of research matures, increasingly rigorous and theoretically therapeutic control conditions may be warranted, both for ethical and scientific reasons.
“As a program of research matures (e.g., moves through the stages of intervention development)11,39,40, increasingly rigorous and theoretically therapeutic control conditions may be warranted, both for ethical (e.g., beneficence and non-maleficence)53 and scientific reasons (i.e., determining how a novel treatment compares with established treatments).”
From Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology (2023) · cites this paper as [39]
There is no single control condition that is appropriate for every study at every stage of the research process.
“There is no single control condition that is appropriate for every study at every stage of the research process11,12,39.”
From Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology (2023) · cites this paper as [39]
In early stages of research, No Treatment controls may be very appropriate to evaluate intervention effects beyond passage of time and related confounds.
“In early stages of research39,40, No Treatment controls may be very appropriate in order to evaluate intervention effects beyond the passage of time and related confounds (e.g., regression to the mean)41.”
From Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology (2023) · cites this paper as [39]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
The proposed intermediate stage is assigned incompatible settings and providers
MinorOne passage describes the stage between efficacy and effectiveness as using research therapists in research settings. The Stage III definition instead places that intermediate stage with community therapists in a community setting.
“defining a stage in between efficacy and effectiveness, where interventions can be tested with high internal validity, with research therapists in research settings”
“This new vision of intervention development includes an additional stage, Stage III, of research where an intervention is tested in a well-controlled, internally valid study in a community setting with community therapists/providers”
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Self-citationWhat is usual about “treatment-as-usual”? Data from two multisite effectiveness trials
Ana, E. J. S., Martino, S., Ball, S. A., Nich, C., Frankforter, T. L., & Carroll, K. M. (2008) · Journal of Substance Abuse Treatment · doi:10.1016/j.jsat.2008.01.003 · Cited by 80 · see citing works
Self-citationMerry, S., & WERRY, J. S. (2000) · Cambridge University Press eBooks · doi:10.1017/cbo9780511526800.011 · Cited by 79 · see citing works
Clinical supervision in effectiveness and implementation research.
Schoenwald, S. K., Mehta, T. G., Frazier, S. L., & Shernoff, E. S. (2013) · Clinical Psychology Science and Practice · doi:10.1111/cpsp.12022 · Cited by 78 · see citing works
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“Another example is the computerized attention modification program that directly targets cognitive biases operating in the most prevalent mood disorders (Amir & Taylor, 2012).”
Treatment development: can we find a better way?
Hayes, S. C., Long, D. M., Levin, M. E., & Follette, W. C. (2013) · Clinical Psychology Review · doi:10.1016/j.cpr.2012.09.009 · Cited by 75 · see citing works
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Henggeler, S. W. (2004) · Journal of Family Psychology · doi:10.1037/0893-3200.18.3.420 · Cited by 71 · cited 1× · see citing works
“For one, we can trace the implementation cliff back to the effect size drop evident in many effectiveness trials (Curtis, Ronan, & Borduin, 2004; Henggeler, 2004; Miller, 2005; Weisz, Weiss, & Donenberg, 1992).”
The dissemination and implementation of psychological treatments: problems and solutions
Fairburn, C. G., & Wilson, G. T. (2013) · International Journal of Eating Disorders · doi:10.1002/eat.22110 · Cited by 64 · cited 1× · see citing works
“…change, and a synthesis of the literature suggests that successful implementation necessitates a sustained, multilevel approach (Damschroder et al., 2009; Fairburn & Wilson, 2013; Fixsen et al., 2005), requiring that multiple barriers be addressed simultaneously for implementation to be successful.”
The research–practice Gap: Bridging the schism between eating disorder researchers and practitioners
Lilienfeld, S. O., Ritschel, L. A., Lynn, S. J., Brown, A. P., Cautin, R. L., & Latzman, R. D. (2013) · International Journal of Eating Disorders · doi:10.1002/eat.22090 · Cited by 59 · cited 4× · see citing works
“…participation of practitioners in a research team that is ready to ask hard questions regarding why the intervention works and how to preserve its effective ingredients while adapting the intervention to fit broader and more varied contexts (Chorpita & Viesselman, 2005; Lilienfeld et al., 2013).”
InfluentialLehman, W. E. K., Simpson, D. D., Knight, D. K., & Flynn, P. M. (2011) · Psychology of Addictive Behaviors · doi:10.1037/a0022682 · Cited by 57 · see citing works
Olmstead, T. A., Abraham, A., Martino, S., & Roman, P. (2011) · Drug and Alcohol Dependence · doi:10.1016/j.drugalcdep.2011.07.017 · Cited by 56 · cited 1× · see citing works
“Direct supervision, via review of clinicians’ levels of fidelity and skill in delivering evidence-based practice, is rarely provided in community-based settings and is also not reimbursed or otherwise incentivized (Olmstead et al., 2012; Schoenwald, Mehta, Frazier, & Shernoff, 2013).”
Otto, M. W., Tolin, D. F., Nations, K. R., Utschig, A. C., Rothbaum, B. O., Hofmann, S. G., & Smits, J. A. J. (2012) · Depression and Anxiety · doi:10.1002/da.21910 · Cited by 54 · cited 1× · see citing works
“For example, with an understanding of mechanisms, Otto et al. (2012) were able to create an ultra-brief treatment for panic disorder.”
Innovative approaches for difficult-to-treat populations
Henggeler, S. W., & Santos, A. B. (1997) · American Psychiatric Press eBooks · Cited by 52 · see citing works
Depersonalization, fantasies, and coping behavior in clinical context
Wolfradt, U., & Engelmann, S. (1999) · Journal of Clinical Psychology · doi:10.1002/(sici)1097-4679(199902)55:2 · Cited by 32 · see citing works
Adding a more Rigorous Scientific Agenda to the Empirically Supported Treatment Movement
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“Many clinical psychology training programs include the teachings of empirically supported treatments or at least engage in debating their value (Baker et al., 2008; Follette & Beitz, 2003).”
Redefining Clinical Science Training
Shoham, V., Rohrbaugh, M. J., Onken, L. S., Cuthbert, B. N., Beveridge, R. M., & Fowles, T. R. (2013) · Clinical Psychological Science · doi:10.1177/2167702613497931 · Cited by 25 · see citing works
Self-citationInvestigating Treatment Mediators When Simple Random Assignment to a Control Group is Not Possible.
Doss, B. D., & Atkins, D. C. (2006) · Clinical Psychology: Science and Practice · doi:10.1111/j.1468-2850.2006.00045.x · Cited by 24 · cited 1× · see citing works
“It may be more complex to incorporate Stage 0 (basic science) into Stage IV than into Stages I to III, but there may be methods for doing so (Collins, Dziak, & Li, 2009; Doss & Atkins, 2006).”
Innovative Approaches for Difficult-to-Treat Populations
Barrett, D. M. (1998) · The Journal of Nervous and Mental Disease · doi:10.1097/00005053-199808000-00016 · Cited by 21 · see citing works
Natural history of obsessional neurosis.
Kringlen, E. (1970) · PubMed · Cited by 20 · see citing works
Motivational interviewing and the incredible shrinking treatment effect
MILLER, W. R. (2005) · Addiction · doi:10.1111/j.1360-0443.2005.01035.x · Cited by 19 · cited 1× · see citing works
“For one, we can trace the implementation cliff back to the effect size drop evident in many effectiveness trials (Curtis, Ronan, & Borduin, 2004; Henggeler, 2004; Miller, 2005; Weisz, Weiss, & Donenberg, 1992).”
Methodological Diversity and Theory in the Stage Model: Reply to Kazdin
Rounsaville, B. J., Carroll, K. M., & Onken, L. S. (2001) · Clinical Psychology Science and Practice · doi:10.1093/clipsy.8.2.152 · Cited by 17 · cited 2× · see citing works
“The conceptual framework of intervention development described in this article is an update of the model described by Onken, Blaine, and Battjes (1997) and Rounsaville, Carroll, and Onken (2001a, 2001b).”
Self-citationIssues for DSM-V: The Limitations of Field Trials: A Lesson From DSM-IV
FRANCES, A. J. (2009) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2009.09071007 · Cited by 14 · see citing works
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“On the other side of the translation-implementation continuum (Shoham et al., 2014), we are missing a tighter link between basic and applied clinical science (Onken & Blaine, 1997; Onken & Bootzin, 1998).”
Self-citationStaying in the Clinical Ballpark While Running the Evidence Bases
Chorpita, B. F., Viesselman, J. O., & Hamilton, J. D. (2005) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/01.chi.0000177058.26408.d3 · Cited by 11 · cited 1× · see citing works
“…participation of practitioners in a research team that is ready to ask hard questions regarding why the intervention works and how to preserve its effective ingredients while adapting the intervention to fit broader and more varied contexts (Chorpita & Viesselman, 2005; Lilienfeld et al., 2013).”
Beyond Context to the Skyline: Thinking in 3D
Hoagwood, K., Olin, S.-C. S., & Cleek, A. F. (2013) · Administration and Policy in Mental Health and Mental Health Services Research · doi:10.1007/s10488-012-0451-7 · Cited by 10 · cited 1× · see citing works
“…are doing all they can to determine how to get interventions adopted and have identified a multitude of program- and system-level constraints and barriers to implementation (e.g., Fixsen, Naoom, Blase, Friedman, & Wallace, 2005; Hoagwood et al., 2013; Lehman, Simpson, Knight, & Flynn, 2011).”
Onken, L. S. (2011) · Journal of Public Health Dentistry · doi:10.1111/j.1752-7325.2011.00221.x · Cited by 9 · cited 1× · see citing works
“Perhaps instead of forcing the square pegs of our evidence-based interventions into the round holes of the delivery system (Onken, 2011) we should consider making our interventions somewhat more round.”
Self-citationBehavioral Therapy Development and Psychological Science: Reinforcing the Bond
Onken, L. S., & BLAINE, J. D. (1997) · Psychological Science · doi:10.1111/j.1467-9280.1997.tb00397.x · Cited by 7 · cited 1× · see citing works
“On the other side of the translation-implementation continuum (Shoham et al., 2014), we are missing a tighter link between basic and applied clinical science (Onken & Blaine, 1997; Onken & Bootzin, 1998).”
Self-citation
Flagged first, then by citations
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Van Dam, N. T., van Vugt, M. K., Vago, D. R., Schmalzl, L., Saron, C. D., Olendzki, A., Meissner, T., Lazar, S. W., Kerr, C. E., Gorchov, J., et al. (2018) · Perspectives on Psychological Science · doi:10.1177/1745691617709589 · Cited by 1,506 · see citing works
“Dimidjian and Segal (2015) estimate, using the NIH stage model for clinical science (Onken, Carroll, Shoham, Cuthbert, & Riddle, 2014), that only 30% of research using mind-fulness-based interventions (MBIs) has moved beyond Stage 1 (intervention generation/refinement).”
What defines mindfulness-based programs? The warp and the weft
Crane, R. S., Brewer, J., Feldman, C., Kabat-Zinn, J., Santorelli, S., Williams, J. M. G., & Kuyken, W. (2017) · Psychological Medicine · doi:10.1017/s0033291716003317 · Cited by 868 · see citing works
“In this editorial we focus on a critical underpinning issue throughout the Stage Model – namely the fi delity/integrity of the intervention itself.”
Carey, R., Bohlen, L. C., Johnston, M., Rothman, A. J., de Bruin, M., Kelly, M. P., & Michie, S. (2018) · Annals of Behavioral Medicine · doi:10.1093/abm/kay078 · Cited by 692 · see citing works
“…their effects, through identification of the links between behavior change techniques (BCTs) and the MoAs they target, Susan Michie s.michie@ucl.ac.uk would enable us to (i) design interventions that include components more likely to be effective [6] and (ii) better explain intervention effects.”
BackgroundMohr, D. C., Lyon, A. R., Lattie, E. G., Reddy, M., & Schueller, S. M. (2017) · Journal of Medical Internet Research · doi:10.2196/jmir.7725 · Cited by 432 · see citing works
“These five phases are (1) intervention generation and refinement, (2) efficacy in research clinics, (3) efficacy in community settings, (4) effectiveness, and (5) implementation [24,25].”
Nielsen, L., Riddle, M., King, J. W., Aklin, W. M., Chen, W., Clark, D., Collier, E., Czajkowski, S., Esposito, L., Ferrer, R., et al. (2018) · Behaviour Research and Therapy · doi:10.1016/j.brat.2017.07.002 · Cited by 446 · see citing works
Self-citationMediation, Moderation, and Conditional Process Analysis
Rockwood, N., & Hayes, A. F. (2020) · Cambridge University Press eBooks · doi:10.1017/9781316995808.037 · Cited by 471 · see citing works
Health Behavior Change: Moving from Observation to Intervention
Sheeran, P., Klein, W. M. P., & Rothman, A. J. (2016) · Annual Review of Psychology · doi:10.1146/annurev-psych-010416-044007 · Cited by 439 · see citing works
Bartlett, L., Martin, A., Neil, A. L., Memish, K., Otahal, P., Kilpatrick, M., & Sanderson, K. (2019) · Journal of Occupational Health Psychology · doi:10.1037/ocp0000146 · Cited by 426 · see citing works
Prospects for a clinical science of mindfulness-based intervention
Dimidjian, S., & Segal, Z. V. (2015) · American Psychologist · doi:10.1037/a0039589 · Cited by 291 · see citing works
Garland, E. L., & Howard, M. O. (2018) · Addiction Science & Clinical Practice · doi:10.1186/s13722-018-0115-3 · Cited by 300 · see citing works
“At this juncture in the development of the field, additional Stage III and IV clinical trials (for a review of the NIH Stage Model, see [71]) are needed to replicate these promising findings via gold-standard research design features including the use of active control conditions, detailed fidelity monitoring procedur…”
Improving Methodological Standards in Behavioral Interventions for Cognitive Enhancement
Green, C. S., Bavelier, D., Kramer, A. F., Vinogradov, S., Ulrich Ansorge, A., Ball, K., Bingel, U., Chein, J. M., Colzato, L. S., Edwards, J. D., et al. (2019) · Journal of Cognitive Enhancement · doi:10.1007/s41465-018-0115-y · Cited by 236 · see citing works
“…model proposed by the NIH discusses the need for studies that target implementation and dissemination (i.e., determining what steps and/or procedures are most useful in ensuring that scientifically validated interventions come into common use among real-world practitioners; Onken et al. 2014).”
BackgroundEisman, A. B., Kilbourne, A. M., Dopp, A. R., Saldana, L., & Eisenberg, D. (2020) · Psychiatry Research · doi:10.1016/j.psychres.2019.06.008 · Cited by 210 · see citing works
Harvey, A. G., & Gumport, N. B. (2015) · Behaviour Research and Therapy · doi:10.1016/j.brat.2015.02.004 · Cited by 221 · see citing works
“This research on MATCH and CALM represents an encouraging ‘new wave’ of Stage 3 and 4 studies, as defined by the Onken et al. (2014) Stage Model of Treatment Development.”
MethodCarroll, K. M., & Kiluk, B. D. (2017) · Psychology of Addictive Behaviors · doi:10.1037/adb0000311 · Cited by 218 · see citing works
Self-citationRawson, T. M., Moore, L. S. P., Hernandez, B., Charani, E., Castro‐Sánchez, E., Herrero, P., Hayhoe, B. W. J., Hope, W. W., Georgiou, P., & Holmes, A. H. (2017) · Clinical Microbiology and Infection · doi:10.1016/j.cmi.2017.02.028 · Cited by 190 · see citing works
“Development[22] and the Medical Research Council’s Developing and Evaluating complex”
Applying mixed methods to pilot feasibility studies to inform intervention trials
Aschbrenner, K. A., Kruse, G. R., Gallo, J. J., & Clark, V. L. P. (2022) · Pilot and Feasibility Studies · doi:10.1186/s40814-022-01178-x · Cited by 188 · see citing works
“Background Intervention research in the health sciences encompasses the procedures used to develop, refine, and test the efficacy and effectiveness of an intervention on a clinical outcome [1, 2].”
Systematic review of social media interventions for smoking cessation
Naslund, J. A., Kim, S. J., Aschbrenner, K. A., McCulloch, L. J., Brunette, M. F., Dallery, J., Bartels, S. J., & Marsch, L. A. (2017) · Addictive Behaviors · doi:10.1016/j.addbeh.2017.05.002 · Cited by 184 · see citing works
Li, W., Garland, E. L., McGovern, P., O’Brien, J. E., Tronnier, C. D., & Howard, M. O. (2017) · Psychology of Addictive Behaviors · doi:10.1037/adb0000269 · Cited by 188 · see citing works
Nápoles, A. M., & Stewart, A. L. (2018) · BMC Health Services Research · doi:10.1186/s12913-018-3521-z · Cited by 163 · see citing works
Loucks, E. B., Schuman-Olivier, Z., Britton, W. B., Fresco, D. M., Desbordes, G., Brewer, J. A., & Fulwiler, C. (2015) · Current Cardiology Reports · doi:10.1007/s11886-015-0668-7 · Cited by 158 · see citing works
Cognitive-behavioral treatment of insomnia and depression in adolescents: A pilot randomized trial
Clarke, G. N., McGlinchey, E. L., Hein, K., Gullion, C. M., Dickerson, J. F., Leo, M. C., & Harvey, A. G. (2015) · Behaviour Research and Therapy · doi:10.1016/j.brat.2015.04.009 · Cited by 158 · see citing works
El Morr, C., Ritvo, P., Ahmad, F., Moineddin, R., & MVC Team (2020) · JMIR Mental Health · doi:10.2196/18595 · Cited by 145 · see citing works
“Our study is currently at stage 2 of the National Institute of Health stage model [39].”
A pragmatic randomized clinical trial of behavioral activation for depressed pregnant women.
Dimidjian, S., Goodman, S. H., Sherwood, N. E., Simon, G. E., Ludman, E. J., Gallop, R., Welch, S. S., Boggs, J. M., Metcalf, C. A., Hubley, S. H., et al. (2017) · Journal of Consulting and Clinical Psychology · doi:10.1037/ccp0000151 · Cited by 133 · see citing works
“Although the efficacy of BA is well established, the effectiveness of BA in routine care settings has not been widely examined, which is a critical step in maximizing public health relevance according to the National Institute of Health Stage Model (Onken, Carroll, Shoham, Cuthbert, & Riddle, 2014).”
Wearable Devices and Smartphones for Activity Tracking Among People with Serious Mental Illness
Naslund, J., Aschbrenner, K., & Bartels, S. (2016) · Mental Health and Physical Activity · doi:10.1016/j.mhpa.2016.02.001 · Cited by 121 · see citing works
“The sequential steps used to refine and evaluate the use of wearable devices and smartphones for activity tracking among people with serious mental illness align closely with recent emphasis at the NIH on adopting an iterative approach to intervention development and evaluation, especially in the context of emerging m…”
Vivanti, G., Kasari, C. L., Green, J., Mandell, D. S., Maye, M. P., & Hudry, K. (2017) · Autism Research · doi:10.1002/aur.1900 · Cited by 143 · see citing works
“, 2013], theory-driven efforts to understand how interventions work are critical to our capacity to adapt, optimize, and customize interventions without diluting their active ingredients [Onken et al., 2014].”
The care planning umbrella: The evolution of advance care planning
Hickman, S. E., Lum, H. D., Walling, A. M., Savoy, A., & Sudore, R. L. (2023) · Journal of the American Geriatrics Society · doi:10.1111/jgs.18287 · Cited by 147 · see citing works
“32 35 The recently updated Consolidated Framework for Implementation Research (CFIR) is a well-established framework for implementing evidence-based interventions in real-world settings.”
Lebares, C. C., Guvva, E. V., Olaru, M., Sugrue, L. P., Staffaroni, A. M., Delucchi, K. L., Kramer, J. H., Ascher, N. L., & Harris, H. W. (2019) · JAMA Network Open · doi:10.1001/jamanetworkopen.2019.4108 · Cited by 131 · see citing works
Kelly, A., & Garland, E. (2016) · Journal of Clinical Psychology · doi:10.1002/jclp.22273 · Cited by 122 · see citing works
Mennin, D. S., Fresco, D. M., O'Toole, M. S., & Heimberg, R. G. (2018) · Journal of Consulting and Clinical Psychology · doi:10.1037/ccp0000289 · Cited by 119 · see citing works
Beets, M. W., von Klinggraeff, L., Weaver, R. G., Armstrong, B., & Burkart, S. A. (2021) · Pilot and Feasibility Studies · doi:10.1186/s40814-021-00909-w · Cited by 111 · see citing works
“As described in translational science frameworks [13, 14], as an intervention moves progressively across the “ maturity continuum ” , there is a need to demonstrate that an intervention can be conducted (i.e., implemented) and shows promise for impacting one or more primary and/or secondary…”
InfluentialHodge, L. M., & Turner, K. M. T. (2016) · American Journal of Community Psychology · doi:10.1002/ajcp.12082 · Cited by 120 · see citing works
Zimmerman, M. A., Eisman, A. B., Reischl, T. M., Morrel‐Samuels, S., Stoddard, S. A., Miller, A. L., Hutchison, P., Franzen, S. P., & Rupp, L. A. (2017) · Health Education & Behavior · doi:10.1177/1090198117710491 · Cited by 115 · see citing works
Vicarious traumatization among child welfare and child protection professionals: A systematic review
Molnar, B. E., Meeker, S. A., Manners, K., Tieszen, L., Kalergis, K. I., Fine, J. E., Hallinan, S., Wolfe, J., & Wells, M. K. (2020) · Child Abuse & Neglect · doi:10.1016/j.chiabu.2020.104679 · Cited by 115 · see citing works
Mindfulness-Based Programs: Why, When, and How to Adapt?
Loucks, E. B., Crane, R. S., Sanghvi, M. A., Montero‐Marín, J., Proulx, J. A., Brewer, J. A., & Kuyken, W. (2022) · Global Advances in Health and Medicine · doi:10.1177/21649561211068805 · Cited by 116 · see citing works
Nazarova, V. A., Sokolov, A. V., Chubarev, V. N., Tarasov, V. V., & Schiöth, H. B. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.1066988 · Cited by 111 · see citing works
“For example, NIH proposes to classify behavioral therapy trials based on the setting of a trial, starting from basic science in the research setting and finishing with trials in community settings (Onken et al., 2014).”
BackgroundBritton, W. B., Davis, J. H., Loucks, E. B., Peterson, B., Cullen, B. H., Reuter, L., Rando, A., Rahrig, H., Lipsky, J., & Lindahl, J. R. (2018) · Behaviour Research and Therapy · doi:10.1016/j.brat.2017.09.010 · Cited by 100 · see citing works
Querstret, D., Cropley, M., & Fife-Schaw, C. (2018) · Mindfulness · doi:10.1007/s12671-018-0925-0 · Cited by 103 · see citing works
“Similarly, in the National Institutes Health Stage Model (Onken et al. 2014), a sixstage progressive model is proposed in the development of behavioural therapies.”
The Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) in Real-World Healthcare Services
Tickell, A., Ball, S., Bernard, P., Kuyken, W., Marx, R., Pack, S., Strauss, C., Sweeney, T., & Crane, C. (2020) · Mindfulness · doi:10.1007/s12671-018-1087-9 · Cited by 99 · see citing works
Kechter, A., Amaro, H., & Black, D. S. (2019) · Mindfulness · doi:10.1007/s12671-018-0974-4 · Cited by 102 · see citing works
“We believe our tool can be used by MBI investigators regardless of study design or study phase in order to develop, monitor, and evaluate treatment fidelity (Onken et al. 2014).”
MethodLindau, S. T., Makelarski, J. A., Abramsohn, E., Beiser, D. G., Boyd, K., Chou, C., Giurcanu, M. C., Huang, E. S., Liao, C., Schumm, L. P., et al. (2019) · American Journal of Public Health · doi:10.2105/ajph.2018.304905 · Cited by 98 · see citing works
“understand how and why these interventions work.(16)”
Roberts, A., Davenport, T. A., Wong, T., Moon, H.-W., Hickie, I. B., & LaMonica, H. M. (2021) · Internet Interventions · doi:10.1016/j.invent.2021.100379 · Cited by 99 · see citing works
“…to the development and implementation of interventions rely on a linear approach, including basic science, intervention creation or adaptation, efficacy testing in both research and clinical settings, effectiveness research in community settings, and finally dissemination (Onken et al., 2014).”
Mak, W. W., Chio, F. H., Chan, A. T., Lui, W. W., & Wu, E. K. (2017) · Journal of Medical Internet Research · doi:10.2196/jmir.6737 · Cited by 94 · see citing works
“One size does not fit all; we need myriad approaches of varying dosage and penetration rates to reach a wider population in order to prevent the tremendous mental illness burden [61,62].”
Advance Care Planning Video Intervention Among Long-Stay Nursing Home Residents
Mitchell, S. L., Volandes, A. E., Gutman, R., Gozalo, P. L., Ogarek, J. A., Loomer, L., McCreedy, E. M., Zhai, R., & Mor, V. (2020) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2020.2366 · Cited by 84 · see citing works
Ritvo, P., Ahmad, F., El Morr, C., Pirbaglou, M., Moineddin, R., & MVC Team (2021) · JMIR Mental Health · doi:10.2196/23491 · Cited by 75 · see citing works
“This study can be characterized as being at stage 2 of the National Institute of Health stage model [37], progressing from a pilot study during which the entire platform was tested.”
Britton, W. B., Desbordes, G., Acabchuk, R. L., Peters, S., Lindahl, J. R., Canby, N. K., Vago, D. R., Dumais, T., Lipsky, J., Kimmel, H. J., et al. (2021) · Frontiers in Psychology · doi:10.3389/fpsyg.2021.730972 · Cited by 81 · see citing works
Mizuno, A., Changolkar, S., & Patel, M. S. (2020) · Annual Review of Medicine · doi:10.1146/annurev-med-050919-031534 · Cited by 80 · see citing works
Hinton, L., Tran, D., Nguyen, T.-N., Ho, J., & Gitlin, L. (2019) · BMJ Global Health · doi:10.1136/bmjgh-2019-001830 · Cited by 82 · see citing works
Intervention Integrity in Mindfulness-Based Research
Crane, R. S., & Hecht, F. M. (2018) · Mindfulness · doi:10.1007/s12671-018-0886-3 · Cited by 75 · see citing works
Matis, J., Svetlak, M., Slezackova, A., Svoboda, M., & Šumec, R. (2020) · doi:10.2196/preprints.20709 · Cited by 81 · see citing works
Beavers, K. M., Ambrosius, W. T., Rejeski, W. J., Burdette, J. H., Walkup, M. P., Sheedy, J. L., Nesbit, B. A., Gaukstern, J. E., Nicklas, B. J., & Marsh, A. P. (2017) · Obesity · doi:10.1002/oby.21977 · Cited by 88 · see citing works
“Moreover, because the intervention was accomplished in a community setting, results are highly translatable and align with the recent National Institutes of Health vision of effectively disseminated clinical intervention research (39).”
Goldberg, S. B., Sun, S., Carlbring, P., & Torous, J. (2023) · npj Digital Medicine · doi:10.1038/s41746-023-00923-7 · Cited by 75 · see citing works
Learmonth, Y. C., & Motl, R. W. (2017) · Pilot and Feasibility Studies · doi:10.1186/s40814-017-0145-8 · Cited by 76 · see citing works
“Stage I data is important to the advancement of stage II and stage III, while data from stage II to V can inform stage I for further refinement of the intervention [19].”
BackgroundMethodInfluentialThinking Health-related Behaviors in a Climate Change Context: A Narrative Review
Chevance, G., Fresán, U., Hekler, E. B., Edmondson, D. E., Lloyd, S. J., Ballester, J., Litt, J., Cvijanović, I., Araújo‐Soares, V., & Bernard, P. (2022) · Annals of Behavioral Medicine · doi:10.1093/abm/kaac039 · Cited by 76 · see citing works
Aschbrenner, K., Naslund, J., Shevenell, M. D., Mueser, K., & Bartels, S. (2016) · Psychiatric quarterly · doi:10.1007/s11126-015-9395-x · Cited by 95 · see citing works
“Consistent with the National Institutes of Health (NIH) Stage Model for behavioral intervention development this small-scale feasibility study was a first step in treatment generation and refinement [23].”
Bright, E. E., Finkelstein, L. B., Nealis, M. S., Genung, S. R., Wrigley, J., Gu, H. C. J., Schmiege, S. J., & Arch, J. J. (2023) · Journal of Clinical Oncology · doi:10.1200/jco.23.00697 · Cited by 74 · see citing works
Carroll, K. M. (2014) · Annals of the New York Academy of Sciences · doi:10.1111/nyas.12501 · Cited by 70 · see citing works
Self-citationDissemination and Implementation of Evidence‐Based Dementia Care Using Embedded Pragmatic Trials
Gitlin, L. N., Baier, R. R., Jutkowitz, E., Baker, Z. G., Gustavson, A. M., Sefcik, J. S., Hodgson, N. A., Koeuth, S., & Gaugler, J. E. (2020) · Journal of the American Geriatrics Society · doi:10.1111/jgs.16622 · Cited by 65 · see citing works
Greenberg, J., Popok, P., Lin, A. C., Kulich, R. J., James, P., Macklin, E. A., Millstein, R. A., Edwards, R. R., & Vranceanu, A. (2020) · JMIR Formative Research · doi:10.2196/18703 · Cited by 59 · see citing works
Behavioral interventions to extend sleep duration: A systematic review and meta-analysis
Baron, K., Duffecy, J., Reutrakul, S., Levenson, J., McFarland, M. M., Lee, S., & Qeadan, F. (2021) · Sleep Medicine Reviews · doi:10.1016/j.smrv.2021.101532 · Cited by 62 · see citing works
“Consistent with the National Institute of Health (NIH) Stage Model of intervention development [8], a variety of studies are needed to adapt promising interventions to maximum potency before these interventions can progress from basic to translational studies.”
Suchman, N. E., DeCoste, C. L., Borelli, J. L., & McMahon, T. J. (2017) · Journal of Substance Abuse Treatment · doi:10.1016/j.jsat.2017.11.006 · Cited by 66 · see citing works
Adapting dialectical behavior therapy for outpatient adult anorexia nervosa—A pilot study
Chen, E. Y., SEGAl, K. E., Weissman, J. L., Zeffiro, T. A., Gallop, R., Linehan, M. M., Bohus, M., & Lynch, T. R. (2014) · International Journal of Eating Disorders · doi:10.1002/eat.22360 · Cited by 65 · see citing works
Teri, L., Logsdon, R. G., McCurry, S. M., Pike, K. C., & McGough, E. L. (2020) · The Gerontologist · doi:10.1093/geront/gny122 · Cited by 66 · see citing works
Greenberg, J., Lin, A. C., Zale, E. L., Kulich, R. J., James, P., Millstein, R. A., Shapiro, H., Schatman, M. E., Edwards, R. R., & Vranceanu, A. (2019) · Journal of Pain Research · doi:10.2147/jpr.s222448 · Cited by 55 · see citing works
The Profound Heterogeneity of Substance Use Disorders: Implications for Treatment Development
Carroll, K. M. (2021) · Current Directions in Psychological Science · doi:10.1177/09637214211026984 · Cited by 67 · see citing works
“Using the National Institutes of Health’s Stage Model of Behavioral Intervention Development as our blueprint for development and evaluation (Onken et al., 2014), we have completed eight independent randomized trials demonstrating CBT4CBT’s efficacy, the durability of its effects, and its effects on skills acquisition…”
Self-citationAggarwal, N. K., Jarvis, G. E., Gómez-Carrillo, A., Kirmayer, L. J., & Lewis‐Fernández, R. (2020) · Transcultural Psychiatry · doi:10.1177/1363461520940481 · Cited by 68 · see citing works
Palmer, J. A., Parker, V. A., Barre, L. R., et al. (2019) · Trials · doi:10.1186/s13063-019-3725-5 · Cited by 59 · see citing works
Suchman, N. E., Ordway, M. R., Kuhn, L. D. L. H., & McMahon, T. J. (2016) · Attachment & Human Development · doi:10.1080/14616734.2016.1226371 · Cited by 65 · see citing works
Ruijgrok-Lupton, P. E., Crane, R. S., & Dorjee, D. (2018) · Mindfulness · doi:10.1007/s12671-017-0750-x · Cited by 64 · see citing works
“The current feasibility pilot study is an initial investigation measuring impact of mindfulnessbased teacher training on participant outcomes, addressing the need for further investigation of MBP clinician training (Dimidjian and Segal 2015, p.605) within the context of stage I of the six-stage NIH model for intervent…”
InfluentialMindfulness-Based Blood Pressure Reduction (MB-BP): Stage 1 single-arm clinical trial
Loucks, E. B., Nardi, W. R., Gutman, R., Kronish, I. M., Saadeh, F. B., Li, Y., Wentz, A. E., Webb, J., Vago, D. R., Harrison, A., et al. (2019) · PLOS ONE · doi:10.1371/journal.pone.0223095 · Cited by 60 · see citing works
“[74, 75] This study’s methodological approach utilized the recommended NIH Stage Model and SOBC framework.[14, 76, 77] The SOBC framework uses an experimental medicine approach that emphasizes four steps, described in more detail elsewhere: (1) Identifying an intervention target (i.”
MethodMcGovern, M. P., Lambert-Harris, C. A., Xie, H., Meier, A., McLeman, B. M., & Saunders, E. C. (2015) · Addiction · doi:10.1111/add.12943 · Cited by 63 · see citing works
Gaiha, S. M., Duemler, A., Silverwood, L., Razo, A., Halpern‐Felsher, B. L., & Walley, S. C. (2020) · Addictive Behaviors · doi:10.1016/j.addbeh.2020.106519 · Cited by 61 · see citing works
Eisman, A. B., Hutton, D. W., Prosser, L. A., Smith, S. N., & Kilbourne, A. M. (2020) · Implementation Science · doi:10.1186/s13012-020-01069-w · Cited by 50 · see citing works
“Evidence-based treatments for mental health conditions, including depression, are essential to improving the public’s health(1).”
Embedded Pragmatic Trials in Dementia Care: Realizing the Vision of the NIA IMPACT Collaboratory
Mitchell, S. L., Mor, V., Harrison, J., & McCarthy, E. P. (2020) · Journal of the American Geriatrics Society · doi:10.1111/jgs.16621 · Cited by 59 · see citing works
Community Weight Loss to Combat Obesity and Disability in At-Risk Older Adults
Rejeski, W. J., Ambrosius, W. T., Burdette, J. H., Walkup, M. P., & Marsh, A. P. (2017) · The Journals of Gerontology Series A: Biological Sciences and Medical Sciences · doi:10.1093/gerona/glw252 · Cited by 58 · see citing works
LaMonica, H. M., Iorfino, F., Lee, G. Y., Piper, S., Occhipinti, J., Davenport, T. A., Cross, S. P. M., Milton, A. C., Ospina‐Pinillos, L., Whittle, L., et al. (2022) · JMIR Mental Health · doi:10.2196/33060 · Cited by 46 · see citing works
“Traditional clinical science approaches to the development and implementation of interventions rely on a lengthy linear process, from basic science through to effectiveness trials and dissemination [41], which can result in delays of up to 17 years for research translation into clinical practice [42].”
Baron, K. G., Duffecy, J. L., Richardson, D., Avery, E., Rothschild, S. K., & Lane, J. (2019) · Journal of Clinical Sleep Medicine · doi:10.5664/jcsm.8018 · Cited by 54 · see citing works
“Exclusion criteria included (1) high risk or presence of sleep disorders, including obstructive sleep apnea (OSA), restless legs syndrome (RLS), or insomnia as assessed by history or screening questionnaires; (2) history of cognitive or neurological disorders; (3) presence of any major psychiatric disorder (eg, bipola…”
Mander, J., Blanck, P., Neubauer, A. B., Kröger, P., Flückiger, C., Lutz, W., Barnow, S., Bents, H., & Heidenreich, T. (2019) · Journal of Clinical Psychology · doi:10.1002/jclp.22695 · Cited by 56 · see citing works
Kelleher, S. A., Fisher, H. M., Winger, J. G., Miller, S. N., Amaden, G. H., Somers, T. J., Colloca, L., Uronis, H. E., & Keefe, F. J. (2022) · Palliative & Supportive Care · doi:10.1017/s1478951521002017 · Cited by 51 · see citing works
Bosk, E. A., Paris, R., Hanson, K. E., Ruisard, D., & Suchman, N. E. (2019) · Children and Youth Services Review · doi:10.1016/j.childyouth.2019.03.040 · Cited by 55 · see citing works
“…et. al. outline six stages: Stage 0 (Basic Research), Stage 1 (Intervention Generation/Refinement), Stage II (Efficacy-Research Clinics), Stage III (Efficacy-Community Clinics), Stage IV (Effectiveness), Stage V (Implementation & Dissemination) for intervention development (Onken et al., 2014)).”
BackgroundTargeting self-regulation to promote health behaviors in children
Miller, A. L., Gearhardt, A. N., Fredericks, E. M., Katz, B., Shapiro, L. F., Holden, K., Kaciroti, N., Gonzalez, R., Hunter, C. M., & Lumeng, J. C. (2017) · Behaviour Research and Therapy · doi:10.1016/j.brat.2017.09.008 · Cited by 54 · see citing works
“Improving self-regulation early in life may be a novel approach to obesity prevention; eating behavior provides an excellent context in which to test a self-regulation behavior change model (Czajkowski, 2016; Onken, 2015; Onken et al., 2014).”
BackgroundConsolidated guidance for behavioral intervention pilot and feasibility studies
Pfledderer, C. D., von Klinggraeff, L., Burkart, S. A., Bandeira, A. D. S., Lubans, D. R., Jago, R., Okely, A. D., van Sluijs, E. M. F., Ioannidis, J. P. A., Thrasher, J. F., et al. (2024) · Pilot and Feasibility Studies · doi:10.1186/s40814-024-01485-5 · Cited by 65 · see citing works
Robinson, S. A., Bisson, A., Hughes, M. L., Ebert, J. E. J., & Lachman, M. E. (2018) · Psychology and Health · doi:10.1080/08870446.2018.1539487 · Cited by 47 · see citing works
Biello, K. B., Hill-Rorie, J., Valente, P. K., Futterman, D. C., Sullivan, P. S., Hightow‐Weidman, L., Muessig, K. E., Dormitzer, J., Mimiaga, M. J., & Mayer, K. H. (2021) · Journal of Medical Internet Research · doi:10.2196/25107 · Cited by 41 · see citing works
“Still, the evaluation of feasibility and acceptability of behavioral interventions in open pilot studies is an important part of the intervention development process and helps inform subsequent randomized controlled trials (RCTs) to evaluate the efficacy of the intervention [66].”
Using Single-Case Experiments to Support Evidence-Based Decisions
Lanovaz, M., & Rapp, J. (2016) · Behavior Modification · doi:10.1177/0145445515613584 · Cited by 46 · see citing works
Norman, S. B., Capone, C., Panza, K. E., Haller, M. M., Davis, B. C., Schnurr, P. P., Shea, M. T., Browne, K. C., Norman, G. J., Lang, A. J., et al. (2022) · Depression and Anxiety · doi:10.1002/da.23244 · Cited by 51 · see citing works
Finlay, J., & Rowles, G. D. (2021) · Wellbeing Space and Society · doi:10.1016/j.wss.2021.100035 · Cited by 47 · see citing works
“A geographical lens can strengthen clinical practice, and enhance the movement toward translational science (Onken et al., 2014) and team-oriented care.”
BackgroundSong, M.-K., Ward, S. E., Hepburn, K., Paul, S., Kim, H., Shah, R. C., Morhardt, D. J., Medders, L., Lah, J. J., & Clevenger, C. C. (2019) · Journal of Palliative Medicine · doi:10.1089/jpm.2019.0088 · Cited by 47 · see citing works
Bird, M., Li, L. H., Ouellette, C., Hopkins, K., McGillion, M. H., & Carter, N. (2019) · JMIR Pediatrics and Parenting · doi:10.2196/15106 · Cited by 42 · see citing works
Multi-session online interpretation bias training for anxiety in a community sample
Ji, J. L., Baee, S., Zhang, D., Calicho-Mamani, C., Meyer, M. J., Funk, D. H., Portnow, S., Barnes, L. E., & Teachman, B. A. (2021) · Behaviour Research and Therapy · doi:10.1016/j.brat.2021.103864 · Cited by 45 · see citing works
Mindfulness Meditation: Impact on Attentional Control and Emotion Dysregulation.
Prakash, R. S. (2021) · PubMed Central · doi:10.1093/arclin/acab053 · Cited by 44 · see citing works
Palitsky, R., & Kaplan, D. M. (2021) · Mindfulness · doi:10.1007/s12671-019-01253-0 · Cited by 46 · see citing works
Goldbach, J. T., Rhoades, H., Mamey, M. R., Senese, J., Karys, P., & Marsiglia, F. F. (2021) · BMC Public Health · doi:10.1186/s12889-021-12357-5 · Cited by 46 · see citing works
“The P&E intervention was named through a democratic vote by youth at LGBT centers after multiple rounds of development, implementation, and revision that followed the NIH Intervention Stage Model for Behavioral Intervention Development [29].”
Orden, K. A. V., & Heffner, K. L. (2022) · The Gerontologist · doi:10.1093/geront/gnac032 · Cited by 45 · see citing works
Cullen, B., Eichel, K., Lindahl, J. R., Rahrig, H., Kini, N., Flahive, J., & Britton, W. B. (2021) · PLOS ONE · doi:10.1371/journal.pone.0244838 · Cited by 43 · see citing works
“In line with mechanism-focused experimental medicine [49,51], both approaches predict that treatments will be maximally beneficial when they reverse baseline pathology or deficits and will be ineffective or contraindicated if baseline pathology is exacerbated or a new imbalance is created.”
BackgroundToward a Mechanistic Understanding of Links Between Close Relationships and Physical Health
Farrell, A. K., & Stanton, S. C. E. (2019) · Current Directions in Psychological Science · doi:10.1177/0963721419855657 · Cited by 41 · see citing works
“As outlined in the stage model (Onken et al., 2014), basic research is critical for developing and refining interventions until they are maximally effective and efficient when implemented in their target populations.”
BackgroundOgbonnaya, I. N., & Keeney, A. J. (2018) · Children and Youth Services Review · doi:10.1016/j.childyouth.2018.10.008 · Cited by 44 · see citing works
Choi, K., Eunju, J., & Lee, G. (2016) · Frontiers in Psychology · doi:10.3389/fpsyg.2016.01759 · Cited by 44 · see citing works
Jacobs, J. M., Post, K. E., Massad, K., Horick, N., Walsh, E. A., Cohn, J. G., Rapoport, C. S., Clara, A. J., Antoni, M. H., Safren, S. A., et al. (2022) · Cancer · doi:10.1002/cncr.34409 · Cited by 41 · see citing works
“Declined to respond 1 (2) 2 (4) 3 (3) Breast cancer stage 0 5 (10) 3 (6) 8 (8) I 36 (72) 41 (82) 77 (77) II 6 (12) 10 (20) 16 (16) III 3 (6) 2 (4) 5 (5) Type of AET Aromatase inhibitor 28 (56) 32 (64) 60 (60) Tamoxifen 22 (44) 18 (36) 40 (40) Primary treatment type Surgery only 10 (20) 13 (26) 23 (23) Surgery and radi…”
Pajka, S. E., Hasdianda, M. A., George, N. R., Sudore, R. L., Schonberg, M. A., Bernstein, E., Tulsky, J. A., Block, S. D., & Ouchi, K. (2020) · Journal of Palliative Medicine · doi:10.1089/jpm.2020.0067 · Cited by 40 · see citing works
“Given that our intervention is in stage 1B (preliminary testing stage) of the Stage Model for Behavioral Intervention Development, where any signal toward the desired outcome is valuable, implementation/dissemination concerns are outside the scope of this study.(54) Enrollments during the first six months (n = 25) of…”
Nahum-Shani, I., Rabbi, M., Yap, J., Philyaw-Kotov, M. L., Klasnja, P., Bonar, E. E., Cunningham, R. M., Murphy, S. A., & Walton, M. A. (2021) · Health Psychology · doi:10.1037/hea0001101 · Cited by 41 · see citing works
“These activities are consistent with Stage I of the NIH Stage Model (Onken et al., 2014), which focuses on intervention creation, refinement and preliminary testing, as well as with the preparation phase of the Multiphase Optimization Strategy (MOST) (Collins, 2018), which focuses on laying the…”
Influential
- Authors
- Onken, L. S., Carroll, K. M., Shoham, V., Cuthbert, B. N., & Riddle, M.
- Affiliations
- National Institute on Drug Abuse (US)
- Yale University (US)
- National Institute of Mental Health (US)
- National Institute of Dental and Craniofacial Research (US)
- Corresponding author
- Onken, Lisa S.
- Venue
- Clinical Psychological Science
- Publisher
- SAGE Publications
- Published
- 2013-12-11
- Volume
- 2
- Issue
- 1
- Pages
- 22-34
- ISSN
- 2167-7026 (ISSN-L)
- 2167-7034
- PMC
- PMC4374633
- OpenAlex
- W2013335489
- Cited by
- 872
- References
- 87
- Citations by year
- 2026: 93 · 2025: 123 · 2024: 107 · 2023: 117 · 2022: 90 · 2021: 101 · 2020: 70 · 2019: 58 · 2018: 35 · 2017: 40 · 2016: 18 · 2015: 12 · 2014: 6 · 2013: 2
- FWCI
- 22.82
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Clinical Psychological Science (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (Z99 DA999999)
- National Institute on Drug Abuse (P50DA009241, U10DA015831, R01DA015969)
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Health and Medical Research Impacts
- Social Sciences › Decision Sciences › Information Systems and Management › Interdisciplinary Research and Collaboration
- Keywords
- clinical science, intervention development, stage model, intervention mechanisms, translational research, research training, implementation, prevention interventions, therapeutic interventions
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