A Phase 2/3 interventional study of Mindfulness-Based Stress Reduction and Cognitive Processing Therapy in Posttraumatic Stress Disorder and Depression, sponsored by US Department of Veterans Affairs. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-02.
Sponsored by US Department of Veterans Affairs · Phase 2/3, Interventional, and Treatment
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.
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
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Exclusion Criteria:
An 8-week program designed to teach mindfulness skills
Behavioral: Mindfulness-Based Stress Reduction
A group-administered PTSD treatment program.
Behavioral: Cognitive Processing Therapy
A validated 8-week group program that teaches mindfulness meditation
Also known as: MBSR
A validated group program of PTSD treatment, which focuses on cognitive processing.
Also known as: CPT
PTSD symptoms
Clinician-administered PTSD Scale (CAPS)
Time frame: 3 months follow-up
Health-related Quality of Life
SF-36V
Time frame: 3 months follow-up
This study is withdrawn, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs