Groups for Regaining Our Wellbeing (GROW)
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Depression, Depression, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | April 2014 |
| End Date: | March 2017 |
| Contact: | David J Kearney, MD |
| Email: | david.kearney@va.gov |
| Phone: | (206) 277-1445 |
A Non-inferiority Trial of MBSR and CPT for PTSD
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.
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.
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.
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.
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.
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