Unified protocol for the discontinuation of long-term serotonin reuptake inhibitors in obsessive compulsive disorder: Study protocol and methods
Open accessAbstract
Obsessive-compulsive disorder (OCD) is chronic psychiatric disorder associated with high rates of functional impairment and decreased quality of life. Although serotonin reuptake inhibitors have demonstrated efficacy in the treatment of OCD, little data is available to guide clinicians on how to manage these medications long-term. Cognitive-behavioral approaches provide a promising avenue for helping OCD patients discontinue maintenance SRIs while minimizing the potential for symptom worsening. This manuscript describes the rationale and methods for pilot feasibility study designed to a unified, cognitive-behavioral strategy for discontinuing long-term SRIs in OCD. The aims of the study are (1) to evaluate the feasibility and acceptability of research procedures and interventions, (2) to test the efficacy of this treatment relative to an enhanced control condition and (3) to investigate the role of distress tolerance in both taper completion and clinical outcome. Our central aim is to investigate whether this approach improves discontinue outcomes relative to an enhanced control condition. Identifying optimal long-term treatment strategies for this population is needed to guide clinicians managing this often-chronic disorder. © 2018 Elsevier Inc.
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Claims the paper makes
12 of 48 cited sources checked · 5 supported · 1 flagged · accuracy not yet measured
- Premisecitation
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders is an empirically supported cognitive-behavioral treatment.
“The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) [22] is an empirically supported, cognitive-behavioral treatment that has been described extensive elsewhere [32–34].”
Quote in the paperSubstantial claim2 of 4 sources checked- cites [22] source
- cites [32] source
- cites [33] source
The Abstract identifies the UP as a cognitive-behavioral treatment, and Protocol Development says it draws on empirically supported CBT treatments. But the Abstract describes evidence for the UP’s own efficacy as preliminary; Preliminary Data reports a 15-patient open trial, not established empirical support for the UP itself. Page numbers are unavailable in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measured - cites [34] source
- Premisecitation
Baseline obsessive-compulsive disorder symptom level is likely a prognostic factor affecting severity and discontinuation outcomes.
“Level of OCD symptomatology at baseline (pre-intervention) is likely a prognostic factor affecting severity and discontinuation outcomes [7] and therefore is controlled during randomization.”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [7] source
The Results sections on SRI discontinuation and the course after discontinuation link OCD symptom status to stopping medication and symptom severity at discontinuation to subsequent worsening. They do not establish that symptom level at baseline, before an intervention, predicts those outcomes; this was a naturalistic study rather than a randomized intervention. Page numbers were not available in our copy. (LLM, conf=0.86)
Experimental — accuracy not yet measured
- Premisecitation
Cognitive behavioral therapy-based approaches have shown promise for facilitating medication discontinuation in anxiety disorders.
“CBT-based approaches have shown promise for facilitating medication discontinuation in anxiety disorders [26,27]; however, studies of OCD have remain largely unaddressed.”
Quote in the paperSubstantial claim1 of 2 sources checked - Premisecitation
Naturalistic observations suggest that most obsessive-compulsive disorder patients stop maintenance serotonin reuptake inhibitors without significant symptom worsening.
“These findings, however, are inconsistent with naturalistic observations suggesting that the majority of OCD patients discontinue maintenance SRIs without significant symptom worsening [7].”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [7] source
The Discussion reports that SRI discontinuation was generally not associated with significant symptom worsening; among patients in partial or full remission who stopped, the cumulative incidence of worsening was 33.3%. But the Results (Discontinuation of serotonin reuptake inhibitors) show that only 43.7% of SRI-treated adults discontinued at least once, so the paper does not support saying that a majority of patients stopped treatment. (LLM, conf=0.88)
Experimental — accuracy not yet measured
- Study design and conductcitation
The combined criteria account for the possibility that participants with lower baseline scores might more easily worsen when only a percentage definition is used.
“This combined criteria also accounts for the fact that participants with lower scores at randomization might more easily worsen when solely using a percentage definition [44].”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [44] source
In “Impact of Different Relapse Criteria on Outcome” (page unavailable), the paper says responders with the lowest posttreatment Week 12 scores could meet a percentage-only relapse threshold after trivial increases. The claim instead specifies scores at randomization, and the paper does not establish that the combined criteria account for this problem. The Discussion (page unavailable) also says it is unclear whether combining severity criteria produces more valid definitions. (LLM, conf=0.88)
Experimental — accuracy not yet measured
- Premisecitation
Long-term use of serotonin reuptake inhibitors is associated with adverse side effects.
“Although widely used and efficacious [8–10], SRI use long-term is associated with adverse side effects [11–14]”
Quote in the paperSubstantial claim0 of 4 sources checked - Premisecitation
Controlled short-term discontinuation studies indicate a moderate-to-high risk of obsessive-compulsive symptom recurrence after abrupt or rapid serotonin reuptake inhibitor discontinuation.
“Controlled short-term SRI discontinuation studies highlight a moderate-to-high risk of OCD symptom reoccurrence following abrupt or rapid discontinuation [18–20].”
Quote in the paperSubstantial claim0 of 3 sources checked - Interpretationreasoning
The Unified Protocol was chosen because it is designed to address dysphoric and distressing states, catastrophic thinking patterns, and comorbidity that may prevent obsessive-compulsive disorder patients from successfully stopping serotonin reuptake inhibitors.
“The UP was selected because it is specifically designed to address the broad experience of dysphoric and distressing states, catastrophic thinking patterns, and comorbidity that may prevent patients with OCD from successfully discontinuing SRIs.”
Quote in the paperSubstantial claim - Premisecitation
Increasing patients' ability to confront and experience uncomfortable emotions adaptively, rather than avoiding them, is a putative mechanism underlying change in the Unified Protocol.
“Indeed, increasing patients’ ability to confront and experience uncomfortable emotions adaptively (non-avoidance) represents a putative mechanism underlying change in the UP [52].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [52]
- Premisecitation
The Credibility/Expectancy Questionnaire has been shown to predict clinical outcomes in previous treatment trials.
“The CEQ has shown to be predictive of clinical outcomes in previous treatment trials [46] and was adapted to include questions on expectancies regarding the likelihood of successful SRI discontinuation.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [46] source
- Study design and conductown data
Because of the sample size, the study cannot test for potential differences in outcome between serotonin reuptake inhibitors with different half-lives or discontinuation symptom profiles.
“Second, due to our sample size we are not able to test for potential differences in outcome between SRIs with different half-lives or discontinuation symptom profiles.”
Quote in the paperNot a substantial claim - Study design and conductreasoning
Because of the likely size of the confidence intervals, the analyses most likely will not permit definitive conclusions.
“We recognize that, due to the likely size of these CIs, these analyses most likely will not permit definitive conclusions.”
Quote in the paperSubstantial claim
- Classified as probably not a substantial claim. 29
- May combine two claims. 18
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationFifteen percent of audiotapes will be randomly selected for review by an independent evaluator using fidelity scales adapted from a prior large-scale randomized controlled trial.
“Fifteen percent of audiotapes will be randomly selected for review by an independent evaluator using fidelity scales adapted from a prior large-scale randomized controlled trial [32].”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [32] source
The Method section (‘Therapists and Treatment Integrity’; page unavailable) says treatment adherence was monitored in weekly supervision but was not systematically assessed. The Discussion (page unavailable) explicitly says treatment fidelity was not evaluated in this trial, contrary to presenting it as the source of fidelity scales for independent audiotape review. (LLM, conf=0.86)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measured
May combine two claims.
PremisecitationSerotonin reuptake inhibitors are the most frequently prescribed medications for obsessive-compulsive disorder, and lifetime use exceeds 90% in treatment-seeking samples.
“Serotonin reuptake inhibitors (SRIs) are the most commonly prescribed medications for OCD [5] with large observational studies estimating lifetime utilization at over 90% in treatment-seeking populations [6,7].”
Quote in the paperNot a substantial claim1 of 3 sources checkedMay combine two claims.
PremisecitationThe ability to tolerate distress and negative emotional states has long been associated with the development and maintenance of psychopathology and with difficulties discontinuing or withdrawing from psychiatric medications and drugs of abuse.
“The ability to tolerate distress negative emotional states has long been associated with the development and maintenance of psychopathology [49–51] as well as difficulties discontinuing or withdrawing from psychiatric medications as well as drugs of abuse [49].”
Quote in the paperSubstantial claim1 of 3 sources checkedMay combine two claims.
Study design and conductcitationThe measures selected for this study mirror those commonly used in obsessive-compulsive disorder treatment outcome trials and are consistent with international expert consensus guidelines for determining treatment response.
“Measures selected for this study mirror those commonly used in treatment outcome trials for OCD [24,36,37] and are consistent with international expert consensus guidelines for determining treatment response [38].”
Quote in the paperNot a substantial claim1 of 4 sources checkedProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationDistress tolerance is central to the theoretical basis of numerous therapeutic approaches.
“Thus, it is not surprising that distress tolerance is central to the theoretical basis of numerous therapeutic approaches [49].”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [49] source
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductcitationREDCap is a secure, password-protected web application designed for research data capture that includes features to reduce missing data and optimize data quality.
“REDCap (Research Electronic Data Capture) [54] is used for data collection, entry and management. REDCap is a secure, password-protected web application designed to support data capture for research studies that includes several features to reduce the amount of missing data and optimize data quality.”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [54] source
The Methods section describes REDCap as a web-based research data-collection application with user authentication, access controls, and validation features intended to ensure data quality. It does not say that those features reduce the amount of missing data; its reference to a “mandatory field type” concerns validating the type of an entry, not requiring an entry. (LLM, conf=0.85)
Experimental — accuracy not yet measured
Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).
Study design and conductnone givenAll treatment sessions, including psychiatrist visits, are audio-recorded to monitor treatment fidelity.
“All treatment sessions, including psychiatrist visits, are audio-recorded to monitor treatment fidelity.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
PremisecitationAbrupt serotonin reuptake inhibitor discontinuation conflicts with clinical practice and American Psychiatric Association guidelines that recommend a slow taper.
“Furthermore, abrupt discontinuation of SRIs is at odds with clinical practice and American Psychiatric Association guidelines recommending slow taper [21].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [21]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationFluoxetine is discontinued by the end of week 4 because of its extended half-life.
“Due to its extended half-life, fluoxetine is discontinued by the end of week 4 [21].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [21]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenThe Institutional Review Boards at Butler Hospital and Brown University approved all study procedures.
“The Institutional Review Boards at Butler Hospital and Brown University approved all study procedures, which are described below.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationCognitive behavioral therapy is an efficacious and effective treatment for obsessive-compulsive disorder, with improvement that persists long-term.
“Cognitive behavioral therapy (CBT) is an efficacious and effective treatment for OCD with improvement that persists long-term [23–25].”
Quote in the paperSubstantial claim0 of 3 sources checkedMay combine two claims.
PremisecitationLong-term serotonin reuptake inhibitor use poses additional challenges, including continuation during pregnancy and potential drug interactions.
“Additional potential challenges include continuation of medication during pregnancy [17] and potential drug interactions [13].”
Quote in the paperNot a substantial claim0 of 2 sources checkedMay combine two claims.
PremisecitationLong-term use of serotonin reuptake inhibitors is associated with adherence problems and financial burden.
“as well as problems with adherence and financial burden [15,16].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [15] source
- cites [16]
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataThe study uses several measures to minimize attrition, including frequent participant contact and collecting contact information for two individuals who could help locate participants.
“The current study employs several measures to minimize attrition, including frequent contact with participants for the duration of the study, including reminder calls prior to study appointments. In addition, as part of the informed consent process, participants are asked to provide contact information for two individuals who could help us locate them if we lose contact.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataThe study is registered on clinicaltrials.gov under identifier NCT02103621.
“This study was funded by the National Institutes of Mental Health (MH100444) and is registered on clinical trials.gov (NCT02103621).”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductreasoningThe enhanced control condition controls for patients' expectation of receiving an intervention, approximates the number and frequency of study visits, and increases systematic monitoring of patient progress.
“This enhanced control condition allows us to: 1) control for the patient’s expectation that they are receiving an intervention; 2) approximate for number and frequency of study visits; 3) increase systematic monitoring of patient progress.”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationreasoningMaintenance serotonin reuptake inhibitor treatment may not be an ideal long-term approach, and some patients may want or need to stop pharmacologic treatment.
“Thus, maintenance SRI treatment may not be an ideal long-term approach and some patients may want or need to discontinue pharmacologic treatment.”
Quote in the paperSubstantial claimMay combine two claims.
Study design and conductcitationUrn randomization assigns participants in a 1:1 allocation while stratifying treatment assignment on baseline obsessive-compulsive disorder severity, using a Yale-Brown Obsessive Compulsive Scale cutoff of 16 or greater.
“Urn randomization is used to assign participants [30] in a 1:1 allocation while stratifying treatment assignment on baseline level of OCD severity (cutoff on the YBOCS ≥ 16) [31].”
Quote in the paperSubstantial claim0 of 2 sources checkedClassified as probably not a substantial claim.
Study design and conductreasoningThe taper is non-blinded by design because the study aims to pilot an intervention hypothesized to limit symptom recurrence by helping patients tolerate distress arising from awareness of serotonin reuptake inhibitor discontinuation.
“The taper is non-blinded by design, as this study aims to pilot an intervention hypothesized to limit symptom recurrence by providing strategies to help patients tolerate distress that may arise due to patients’ awareness of SRI discontinuation (e.g., catastrophic thoughts around likelihood of abrupt symptom reoccurrence, misinterpretation of interoceptive cues).”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductcitationObsessive-compulsive disorder symptoms are assessed for eligibility using the clinician-rated Yale Brown Obsessive-Compulsive Scale and Symptom Checklist, which is the gold-standard for obsessive-compulsive disorder assessment.
“OCD symptoms are assessed for the determination of eligibility at intake using the clinician-rated Yale Brown Obsessive-Compulsive Scale and Symptom Checklist (YBOCS) [31,39], the gold-standard for OCD assessment.”
Quote in the paperNot a substantial claim0 of 2 sources checkedClassified as probably not a substantial claim.
Study design and conductnone givenThe criteria for determining significant symptom worsening and initiation of rescue treatment were developed a priori.
“The criteria for determining significant symptom worsening and initiation of rescue treatment were developed a priori and are follows:”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationSerotonin reuptake inhibitors are tapered slowly at a rate consistent with clinical practice and American Psychiatric Association treatment guidelines.
“Consistent with American Psychiatric Association treatment guidelines [21], SRIs are tapered slowly, at a rate consistent with that used in clinical practice.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [21]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductreasoningAll interviews are audio-recorded for review to help ensure that valid and reliable data are collected.
“To ensure that valid and reliable data are collected, all interviews are audio-recorded for review.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Study design and conductnone givenUnless otherwise specified, all measures, including primary and secondary outcome measures, are administered and collected by Ph.D.-level independent evaluators who are naive to study condition.
“Unless otherwise specified, all measures –including primary and secondary outcome measures – are administered and collected by Ph.D.-level independent evaluators (IEs) naive to study condition.”
Quote in the paperSubstantial claimMay combine two claims.
Study design and conductreasoningThe inclusion and exclusion criteria are designed to maximize participant safety, but they limit the ability to generalize results to more severe patient populations or those with high comorbidity.
“While our inclusion and exclusion criteria are designed to maximize the safety of participants in this trial, it limits our ability to generalize our results to more severe patient populations or those with high degrees of comorbidity.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenA data monitoring and safety board established at the start of the study provides external monitoring of data integrity.
“In addition, a data monitoring and safety board (DSMB) established at the start of the study, provides external monitoring of data integrity.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenParticipants are monitored weekly for symptom worsening during the acute discontinuation phase and biweekly during the booster phase.
“Participants are monitored on a weekly basis for symptom worsening during the acute discontinuation phase and biweekly during the booster phase of this study.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
PremisecitationKraemer and colleagues emphasized the limitations of using pilot data to estimate an effect size because of the likelihood of a large standard error around the effect size estimate.
“Although widely adopted, Kraemer et al. [55] emphasized the limitations of this practice due to the likelihood of a large standard error surrounding the effect size estimate.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [55] source
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenAll independent evaluators are Ph.D.-level researchers with extensive prior diagnostic assessment experience.
“All independent evaluators are Ph.D.-level researchers with extensive prior diagnostic assessment experience.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenThe data monitoring and safety board meets biannually to review recruitment rates, treatment retention, quality assurance or regulatory issues, adverse events or serious adverse events, and protocol actions or changes.
“The DSMB meets on a biannual basis to review expected versus actual recruitment rates, treatment retention rates, any quality assurance or regulatory issues that occurred during the prior 6 months, any adverse events or serious adverse events (SAEs), and any actions or changes with respect to the protocol.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenAll independent evaluators receive additional training on the primary clinical outcome measures before conducting study assessments.
“Regardless of familiarity with study assessment measures, all IEs receive additional training on the primary clinical outcome measures prior to conducting study assessments.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Study design and conductreasoningAny participant meeting the significant-worsening criteria for two consecutive weeks is considered significantly worsened and referred for doctor's choice rescue treatment.
“Any participant meeting these criteria for 2 consecutive weeks – ensuring that the symptom exacerbation is stable rather than a random fluctuation or temporary lapse—are considered to have significantly worsened and referred for doctor’s choice rescue treatment (e.g., reinstitution of SRI).”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
Study design and conductreasoningAcceptability and satisfaction measures are administered at the end of the acute treatment period by research assistants not otherwise involved in the study, in order to maintain the blind of the independent evaluators.
“To maintain the blind of the IEs, these acceptability and satisfaction measures are administered at the end of the acute treatment period (week 14) by RAs not otherwise involved in the study.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
Study design and conductreasoningThe definition of significant symptom worsening requires participants to meet full criteria for obsessive-compulsive disorder, which corresponds to a Yale-Brown Obsessive Compulsive Scale cut-point of 16.
“This definition requires participants to meet full criteria for OCD, which is associated with a cut-point of 16 on the YBOCS.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Study design and conductnone givenBefore conducting interviews, independent evaluators must meet a reliability threshold of ICC = .80 with established raters.
“Prior to conducting interviews, IEs must meet a reliability threshold (ICC = .80) with established raters.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
PremisecitationSizeable progress has been made in behavioral and pharmacologic treatments for obsessive-compulsive disorder.
“Sizeable progress has been made in behavioral and pharmacologic treatments for OCD [56,57], however, there remain significant questions regarding the long-term management of the disorder.”
Quote in the paperNot a substantial claim0 of 2 sources checkedProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenThe data monitoring and safety board consists of four independent MD- or PhD-level members with expertise in obsessive-compulsive disorder clinical trials, statistical methodology, and medication discontinuation in psychiatric populations.
“The DSMB consists of 4 independent MD or PhD-level board members with expertise in OCD clinical trials, statistical methodology, and medication discontinuation in psychiatric populations.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenResearch assistants follow a standard training protocol under the direction of the study investigators and the Clinical Assessment and Training Unit at Brown University.
“RAs follow our standard training protocol under the direction of the study investigators and the Clinical Assessment and Training Unit at Brown University.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductnone givenSeveral data monitoring procedures are implemented to ensure data quality, including double data entry for paper forms, recording study notes-to-file for events threatening data integrity, and routine internal audits.
“Several data monitoring procedures are implemented to ensure data quality: (1) double data entry for all data recorded on paper forms, (2) systematically recording study notes-to-file in the case of any event that threatens data integrity, and (3) routine internal audits confirming proper informed consent, accurate completion of data forms and documentation of missing data.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
Little is known about how to optimize long-term treatment of obsessive-compulsive disorder.
“Despite increased recognition of its public health significance, surprisingly little is known about how to optimize long-term treatment of the disorder.”
The paper relies on this without support.
Few controlled studies have examined discontinuation in obsessive-compulsive disorder patients maintained on serotonin reuptake inhibitors for longer than one year.
“However, there have been few controlled studies examining discontinuation in OCD patients maintained on SRIs longer than one year.”
The paper relies on this without support.
Studies of obsessive-compulsive disorder have remained largely unaddressed with respect to cognitive behavioral therapy-based approaches for facilitating medication discontinuation.
“CBT-based approaches have shown promise for facilitating medication discontinuation in anxiety disorders [26,27]; however, studies of OCD have remain largely unaddressed.”
The paper relies on this without support.
No studies to date have focused specifically on long-term serotonin reuptake inhibitors in obsessive-compulsive disorder.
“Moreover, no studies to date have focused specifically on long-term SRIs, despite frequent use in OCD populations and the challenges presented by maintenance treatment.”
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The Distress Tolerance Scale: Development and Validation of a Self-Report Measure
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“Perceived ability to tolerate emotional distress is assessed with the 15-item self-report Distress Tolerance Scale (DTS) [53] at baseline, mid-treatment (week 7), post-treatment and follow-up.”
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“Treatment history is assessed using the medication and treatment history interview from the Longitudinal Interval Followup Evaluation [41].”
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Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: A Randomized Controlled Trial
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“Fifteen percent of audiotapes will be randomly selected for review by an independent evaluator using fidelity scales adapted from a prior large-scale randomized controlled trial [32].”
MethodSelf-citation. Caution regarding the use of pilot studies to guide power calculations for study proposals.
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“[55] emphasized the limitations of this practice due to the likelihood of a large standard error surrounding the effect size estimate.”
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“Sizeable progress has been made in behavioral and pharmacologic treatments for OCD [56,57], however, there remain significant questions regarding the long-term management of the disorder.”
BackgroundSelective serotonin reuptake inhibitor discontinuation syndrome: a randomized clinical trial
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MethodHoarding disorder: a new diagnosis for DSM-V?
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- Authors
- Boisseau, C. L., & Rasmussen, S. A.
- Affiliations
- Brown University (US)
- Corresponding author
- Boisseau, Christina L.
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2018-02
- Volume
- 65
- Pages
- 157-163
- ISSN
- 1551-7144 (ISSN-L)
- PMC
- PMC5803458
- OpenAlex
- W2781974622
- Cited by
- 0
- References
- 66
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Contemporary Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Mental Health (NCT02103621, MH100444, MH1000444)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Obsessive-Compulsive Spectrum Disorders
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Social Sciences › Psychology › Clinical Psychology › Psychoanalysis and Psychopathology Research
- Keywords
- obsessive-compulsive disorder, serotonin reuptake inhibitors, drug discontinuation, tapering, cognitive behavioral therapy, distress tolerance, maintenance pharmacotherapy
- MeSH terms
- Feasibility Studies, Female, Humans, Male, Obsessive-Compulsive Disorder, Pilot Projects, Quality of Life, Research Design, Stress, Psychological, Cognitive Behavioral Therapy, Randomized Controlled Trials as Topic, Clinical Trials, Phase I as Topic, Selective Serotonin Reuptake Inhibitors
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