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Cognitive-behavioral group treatment for veterans diagnosed with PTSD: Design of a hybrid efficacy-effectiveness clinical trial.

ABSTRACT: Despite significant advances in individual treatment approaches for PTSD, knowledge of group approaches has lagged behind. Much of the reason knowledge about group treatment for PTSD has been limited is due to the complexity of conducting randomized controlled trials in the group treatment context. This limited empirical knowledge is unfortunate given the frequency with which group treatment for PTSD is used in clinical settings, including the Department of Veteran Affairs. The goal of this study is to examine the efficacy of a group cognitive-behavioral treatment (GCBT) for PTSD relative to group supportive counseling approach (i.e. group present centered treatment; GPCT). The sample consists of 196 veterans diagnosed with PTSD who are randomly assigned to either GCBT (n=98) or GPCT (n=98). Both treatments are administered by two therapists over the course of 14 sessions. Assessments take place at baseline, mid-treatment, post-treatment and 3-, 6-, and 12-month follow-up. The primary outcome measure is the PTSD symptom severity assessed with a semi-structured diagnostic instrument. Given the substantial rise of veterans presenting for PTSD treatment services, identifying an efficacious group treatment approach is invaluable.

SUBMITTER: Sloan DM

PROVIDER: S-EPMC4838993 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Cognitive-behavioral group treatment for veterans diagnosed with PTSD: Design of a hybrid efficacy-effectiveness clinical trial.

Sloan Denise M DM Unger William W Gayle Beck J J

Contemporary clinical trials 20151221

Despite significant advances in individual treatment approaches for PTSD, knowledge of group approaches has lagged behind. Much of the reason knowledge about group treatment for PTSD has been limited is due to the complexity of conducting randomized controlled trials in the group treatment context. This limited empirical knowledge is unfortunate given the frequency with which group treatment for PTSD is used in clinical settings, including the Department of Veteran Affairs. The goal of this stud ...[more]

PMID: 26718094

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Project description: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.

Project description:BACKGROUND:Broadly disseminating and implementing evidence-based psychotherapies with high fidelity, particularly cognitive behavioral therapy (CBT), has proved challenging for many health-care systems, including the Department of Veterans Affairs, especially in primary care settings such as small or remote clinics. A computer-based tool (based on the coordinated anxiety learning and management (CALM) program) was designed to support primary care-based mental health providers in delivering CBT. The objectives of this study are to modify the CALM tool to meet the needs of mental health clinicians in veterans affairs (VA) community-based outpatient clinics (CBOCs) and rural "veterans", use external facilitation to implement CBT and determine the effect of the CALM tool versus a manualized version of CALM to improve fidelity to the CBT treatment model, and conduct a needs assessment to understand how best to support future implementation of the CALM tool in routine care. METHODS/DESIGN:Focus groups will inform the redesign of the CALM tool. Mental health providers at regional VA CBOCs; CBT experts; VA experts in implementation of evidence-based mental health practices; and veterans with generalized anxiety disorder, panic disorder, social anxiety disorder, posttraumatic stress disorder, "with or without" depression will be recruited. A hybrid type III design will be used to examine the effect of receiving CBT training plus either the CALM tool or a manual version of CALM on treatment fidelity. External facilitation will be used as the overarching strategy to implement both CBT delivery methods. Data will also be collected on symptoms of the targeted disorders. To help prepare for the future implementation of the CALM tool in VA CBOCs, we will perform an implementation need assessment with mental health providers participating in the clinical trial and their CBOC directors. DISCUSSION:This project will help inform strategies for delivering CBT with high fidelity in VA CBOCs to veterans with anxiety disorders and PTSD with or without depression. If successful, results of this study could be used to inform a national rollout of the CALM tool in VA CBOCs including providing recommendations for optimizing the adoption and sustained use of the computerized CALM tool among mental health providers in this setting. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02488551.

Project description:Rural African Americans are disproportionately exposed to numerous stressors such as poverty that place them at risk for experiencing elevated levels of depressive symptoms. Effective treatments for decreasing depressive symptoms exist, but rural African Americans often fail to receive adequate and timely care. Churches have been used to address physical health outcomes in rural African American communities, but few have focused primarily on addressing mental health outcomes. Our partnership, consisting of faith community leaders and academic researchers, adapted an evidence-based behavioral activation intervention for use with rural African American churches. This 8-session intervention was adapted to include faith-based themes, Scripture, and other aspects of the rural African American faith culture (e.g. bible studies) This manuscript describes a Hybrid-II implementation trial that seeks to test the effectiveness of the culturally adapted evidence-based intervention (Renewed and Empowered for the Journey to Overcome in Christ: REJOICE) and gather preliminary data on the strategies necessary to support the successful implementation of this intervention in 24 rural African American churches. This study employs a randomized one-way crossover cluster design to assess effectiveness in reducing depressive symptoms and gather preliminary data regarding implementation outcomes, specifically fidelity, associated with 2 implementation strategies: training only and training+coaching calls. This project has the potential to generate knowledge that will lead to improvements in the provision of mental health interventions within the rural African American community. Further, the use of the Hybrid-II design has the potential to advance our understanding of strategies that will support the implementation of and sustainability of mental health interventions within rural African American faith communities. TRIAL REGISTRATION:NCT02860741. Registered August 5, 2016.

Dataset Information

Cognitive-behavioral group treatment for veterans diagnosed with PTSD: Design of a hybrid efficacy-effectiveness clinical trial.

Publications

Cognitive-behavioral group treatment for veterans diagnosed with PTSD: Design of a hybrid efficacy-effectiveness clinical trial.

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