Groups for Regaining Our Wellbeing (GROW)

Study Overview
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Brief Summary
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The proposed study is a randomized, controlled trial that will assess whether two group interventions for PTSD - Mindfulness-Based Stress Reduction (MBSR) and Cognitive Processing Therapy-Cognitive only (CPT-C) result in similar improvements in PTSD symptoms and health-related quality of life (QOL). One hundred fifty-two Veterans with PTSD will be randomized to MBSR (n = 76) or CPT-C (n = 76). Comprehensive assessments will take place post-treatment and 3 months later.

Detailed Description
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The proposed study is a randomized, controlled non-inferiority trial that will assess whether Mindfulness-Based Stress Reduction (MBSR) and Cognitive Processing Therapy-Cognitive only (CPT-C) result in equivalent improvement in both PTSD symptoms and health-related quality of life (QOL). PTSD symptoms will be measured by the Clinician Administered PTSD Scale - CAPS and health-related QOL will be measured by the SF-36V Mental Component Summary Score - MCS. In an exploratory aim, we will also assess whether there is a clinically meaningful response as defined by improvement in both PTSD symptoms and QOL (defined as a reliable change of 12 points on the CAPS and 10 points on the MCS, respectively, according to the reliable change index).7, 8 One hundred fifty-two Veterans with PTSD will be randomized to MBSR (n = 76) or CPT-C (n = 76). Comprehensive assessments will take place post-treatment and 3 months later. Qualitative analysis of brief semi-structured interview data will be used to identify previously unrecognized factors pertaining to participation, adherence and response to treatment, spirituality and religion as treatment moderators, and to identify common themes that may inform treatment retention efforts for both MBSR and CPT-C. In addition, potential moderators of change in PTSD symptoms and QOL for MBSR and CPT-C will be identified.

Official Title
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A Non-inferiority Trial of MBSR and CPT for PTSD

Conditions
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Posttraumatic Stress Disorder, Depression

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction
* Behavioral: Cognitive Processing Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans with current DSM-V diagnosis of PTSD Exclusion Criteria: Current substance use disorder other than alcohol, Alcohol involvement that poses a safety concern or is associated with inability to follow through on assessments and class attendance as evinced by past month appointment attendance record in CPRS, Suicidal or homicidal ideation with intent or plan within the past 3 months, Self harm in the past 3 months, A psychotic disorder, Uncontrolled bipolar disorder, Chart diagnoses of borderline personality disorder or antisocial personality disorder, In-patient admission for psychiatric reasons within the past month, Prior participation in MBSR or CPT.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Stress Reduction (MBSR)<br>An 8-week program designed to teach mindfulness skills | Behavioral: Mindfulness-Based Stress Reduction<br>* A validated 8-week group program that teaches mindfulness meditation<br>* Other names: MBSR;|
| Active Comparator: Cognitive Processing Therapy<br>A group-administered PTSD treatment program. | Behavioral: Cognitive Processing Therapy<br>* A validated group program of PTSD treatment, which focuses on cognitive processing.<br>* Other names: CPT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptoms | Clinician-administered PTSD Scale (CAPS) | 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life | SF-36V | 3 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, behavior therapies, cognitive, posttraumatic stress disorder, group therapy