Groups for Regaining Our Wellbeing (GROW)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-03-31

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.

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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.

Conditions

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Posttraumatic Stress Disorder Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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Mindfulness-Based Stress Reduction (MBSR)

An 8-week program designed to teach mindfulness skills

Group Type EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type BEHAVIORAL

A validated 8-week group program that teaches mindfulness meditation

Cognitive Processing Therapy

A group-administered PTSD treatment program.

Group Type ACTIVE_COMPARATOR

Cognitive Processing Therapy

Intervention Type BEHAVIORAL

A validated group program of PTSD treatment, which focuses on cognitive processing.

Interventions

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Mindfulness-Based Stress Reduction

A validated 8-week group program that teaches mindfulness meditation

Intervention Type BEHAVIORAL

Cognitive Processing Therapy

A validated group program of PTSD treatment, which focuses on cognitive processing.

Intervention Type BEHAVIORAL

Other Intervention Names

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MBSR CPT

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No