Brief cognitive behavioral therapy in primary care: a hybrid type 2 patient-randomized effectiveness implementation design
Open accessAbstract
BACKGROUND: Despite the availability of evidence-based psychotherapies for depression and anxiety, they are underused in non-mental health specialty settings such as primary care. Hybrid effectiveness-implementation designs have the potential to evaluate clinical and implementation outcomes of evidence-based psychotherapies to improve their translation into routine clinical care practices. METHODS: This protocol article discusses the study methodology and implementation strategies employed in an ongoing, hybrid, type 2 randomized controlled trial with two primary aims: (1) to determine whether a brief, manualized cognitive behavioral therapy administered by Veterans Affairs Primary Care Mental Health Integration program clinicians is effective in treating depression and anxiety in a sample of medically ill (chronic cardiopulmonary diseases) primary care patients and (2) to examine the acceptability, feasibility, and preliminary outcomes of a focused implementation strategy on improving adoption and fidelity of brief cognitive behavioral therapy at two Primary Care-Mental Health Integration clinics. The study uses a hybrid type 2 effectiveness/implementation design to simultaneously test clinical effectiveness and to collect pilot data on a multifaceted implementation strategy that includes an online training program, audit and feedback of session content, and internal and external facilitation. Additionally, the study engages the participation of an advisory council consisting of stakeholders from Primary Care-Mental Health Integration, as well as regional and national mental health leaders within the Veterans Administration. It targets recruitment of 320 participants randomized to brief cognitive behavioral therapy (n = 200) or usual care (n = 120). Both effectiveness and implementation outcomes are being assessed using mixed methods, including quantitative evaluation (e.g., intent-to-treat analyses across multiple time points) and qualitative methods (e.g., focus interviews and surveys from patients and providers). Patient-effectiveness outcomes include measures of depression, anxiety, and physical health functioning using blinded independent evaluators. Implementation outcomes include patient engagement and adherence and clinician brief cognitive behavioral therapy adoption and fidelity. CONCLUSIONS: Hybrid designs are needed to advance clinical effectiveness and implementation knowledge to improve healthcare practices. The current article describes the rationale and challenges associated with the use of a hybrid design for the study of brief cognitive behavioral therapy in primary care. Although trade-offs exist between scientific control and external validity, hybrid designs are part of an emerging approach that has the potential to rapidly advance both science and practice. TRIAL REGISTRATION: NCT01149772 at http://www.clinicaltrials.gov/ct2/show/NCT01149772.
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Cully et al. concurrently collected implementation data including feasibility and acceptability of the clinical intervention and impact of the implementation strategy package.
“They concurrently collected implementation data including the feasibility and acceptability of the clinical intervention as well as data on the impact of the implementation strategy package (i.e., online clinician training, enhanced referral and scheduling, clinician audit and feedback, and internal and external facilitation).”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Cully et al. (2012)
The Methods’ implementation evaluation plan describes collecting stakeholder interviews on bCBT acceptability and feasibility and on the impact of implementation interventions. The implementation strategy section names online training, clinician audit and feedback, and internal and external facilitation, but does not identify enhanced referral and scheduling as a separate package component. This is a study-design paper describing planned data collection, rather than reporting that the data had already been collected. (LLM, conf=0.86)
Experimental — accuracy not yet measuredPatients in Cully et al. (2012) were randomized to treatment condition.
“Patients were randomized to treatment condition.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Cully et al. (2012)
The Methods section (page unavailable) specifies random assignment to the ACCESS and usual-care conditions and describes the allocation procedure. However, this is a study-design paper: it says patients “will be randomized” and does not establish that the randomization had been completed, as the claim’s past tense implies. (LLM, conf=0.84)
Experimental — accuracy not yet measuredBy collecting data on the impact of implementation strategies, Cully et al. (2012) were able to gather information to prepare for an implementation trial of the strategies.
“By collecting data on the impact of the implementation strategies, Cully et al. (2012) were able to gather information to prepare for an implementation trial of the implementation strategies in which the tested strategies would be randomized and compared across intervention sites.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Cully et al. (2012)
The Discussion (Methodological challenge #3; page not provided) says the team sought to refine implementation procedures for a future trial and aimed to study a refined strategy using a cluster-randomized design. The Methods (Implementation evaluation plan and analyses; page not provided) says the planned data collection would inform future trials. This is a study design paper: it does not establish that the authors had already collected those data or prepared a trial comparing randomized strategies across sites. (LLM, conf=0.86)
Experimental — accuracy not yet measuredCully et al. conducted an intent-to-treat analysis of clinical outcomes (N = 320).
“To measure effectiveness, Cully et al. conducted an intent-to-treat analysis of clinical outcomes (N = 320).”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Cully et al. (2012)
The Methods section (‘Clinical effectiveness: analyses’) says quantitative clinical-outcome analyses will be conducted on an intention-to-treat basis. ‘Identification and recruitment of participants’ gives 320 as the planned total sample size. This is a study-design paper; these passages do not show that Cully et al. had already conducted an analysis of 320 patients. (LLM, conf=0.90)
Experimental — accuracy not yet measuredCully et al. measured clinician knowledge acquisition and fidelity to the model.
“To gather information about the impact of the implementation strategies, Cully et al. measured clinician knowledge acquisition and fidelity to the model.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Cully et al. (2012)
The Methods section’s study-outcomes table identifies clinician adherence and competency ratings from expert audio-session reviews as measures of implementation fidelity; the audit-and-feedback section describes those reviews. The paper describes clinician training and collection of pretrial expertise data, but does not identify a measure of clinician knowledge acquisition. It is a study-design paper, so it describes planned measurements rather than reporting completed results. (LLM, conf=0.86)
Experimental — accuracy not yet measured
Cully et al. (2012) study differentiates from a hybrid type 1 design due to explicit measurement of strategies' impact on intervention feasibility and acceptability.
“This differentiates the study from a hybrid type 1 design due to the explicit measurement of the strategies’ impact on the intervention’s feasibility and acceptability.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Cully et al. (2012)
The Background distinguishes type 1 designs, which have minimal implementation strategies, from type 2 designs, which balance effectiveness and implementation. Methods, Objective #2 (page unavailable), says the study evaluates the acceptability, feasibility, and preliminary outcomes of an implementation strategy. It does not say the study explicitly measures the strategy’s impact on the clinical intervention’s feasibility and acceptability. (LLM, conf=0.84)
Experimental — accuracy not yet measuredBy utilizing posttreatment follow-up, Cully et al. measured provision of the intervention after trial completion to assess sustainability.
“By utilizing the posttreatment follow-up, Cully et al. were able to measure the provision of the intervention after the trial was completed in order to assess the intervention’s sustainability.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Cully et al. (2012)
The Methods section (‘Implementation evaluation plan and analyses’; page unavailable) says the researchers planned to use the longer-term posttreatment follow-up period to survey clinicians about bCBT use six months after study implementation efforts ended. This supports the proposed assessment of continued intervention use, but the paper describes a plan, not a completed measurement, and specifies completion of implementation efforts rather than completion of the trial. (LLM, conf=0.88)
Experimental — accuracy not yet measuredCully et al. conducted qualitative interviews about clinicians' attitudes that may impact implementability.
“They also conducted qualitative interviews to gather information about the clinicians’ attitudes (e.g., perception of intervention’s importance) that may impact the intervention’s implementability.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Cully et al. (2012)
The Methods section (“Implementation evaluation plan and analyses”) says the researchers planned semistructured interviews with clinicians and other stakeholders about the importance of bCBT, its potential adoption, and barriers to implementation. It says the interviews “will be conducted,” however, so this paper does not establish that Cully et al. conducted them. (LLM, conf=0.86)
Experimental — accuracy not yet measuredCully et al. (2012) included a clinical trial of brief cognitive behavioral therapy for treating depression and anxiety and piloting of an implementation strategy.
“This study included a clinical trial of brief cognitive behavioral therapy for treating depression and anxiety and piloting of an implementation strategy.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Cully et al. (2012)
Both sites in Cully et al. (2012) received the same bundle of implementation strategies.
“Both sites involved in the trial received the same bundle of implementation strategies.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Cully et al. (2012)
Cully et al. (2012) is an example of a type 2 hybrid.
“Here we present a paper by Cully et al. (2012) as an example of a type 2 hybrid.”
From An introduction to effectiveness-implementation hybrid designs (2019) · cites this paper as Cully et al. (2012)
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Self-management interventions for people with chronic obstructive pulmonary disease
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Self-citationEnhancing the reporting of implementation research
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The next phase in professional services research: From implementation to sustainability
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Online CBT training for mental health providers in primary care
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Implementation science in hybrid randomized controlled trials: a state-of-the-art systematic review
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- Authors
- Cully, J. A., Armento, M. E. A., Mott, J., Nadorff, M. R., Naik, A. D., Stanley, M. A., Sorocco, K. H., Kunik, M. E., Petersen, N. J., & Kauth, M. R.
- Affiliations
- Michael E. DeBakey VA Medical Center (US)
- Oklahoma City VA Medical Center (US)
- Corresponding author
- Cully, Jeffrey A
- ORCID
- Venue
- Implementation Science
- Published
- 2012-07-11
- Volume
- 7
- Issue
- 1
- Pages
- 64-64
- ISSN
- 1748-5908 (ISSN-L)
- PMC
- PMC3503767
- OpenAlex
- W1998795432
- Cited by
- 72
- References
- 74
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 4 · 2023: 2 · 2022: 4 · 2021: 7 · 2020: 6 · 2019: 11 · 2018: 6 · 2017: 10 · 2016: 5 · 2015: 6 · 2013: 5
- FWCI
- 6.26
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Implementation Science (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- U.S. Department of Veterans Affairs (IIR 09-088)
- Office of Research and Development
- Health Services Research and Development (09-088, HFP90‐020)
- NIH Clinical Center
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- brief cognitive behavioral therapy, primary care, depression, anxiety, implementation strategies, intervention fidelity, audit and feedback, primary care mental health integration, veterans, chronic cardiopulmonary disease, implementation outcomes, clinical effectiveness
- MeSH terms
- Clinical Protocols, Heart Failure, Humans, Mental Health Services, Outcome and Process Assessment, Health Care, Primary Health Care, Research Design, United States, United States Department of Veterans Affairs, Cognitive Behavioral Therapy, Randomized Controlled Trials as Topic, Evidence-Based Medicine, Pulmonary Disease, Chronic Obstructive
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