Groups for Regaining Our Wellbeing (GROW)
GROW
A Non-inferiority Trial of MBSR and CPT for PTSD
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2013
CompletedFirst Posted
Study publicly available on registry
October 29, 2013
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJuly 2, 2014
July 1, 2014
2.9 years
October 23, 2013
July 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PTSD symptoms
Clinician-administered PTSD Scale (CAPS)
3 months follow-up
Secondary Outcomes (1)
Health-related Quality of Life
3 months follow-up
Study Arms (2)
Mindfulness-Based Stress Reduction (MBSR)
EXPERIMENTALAn 8-week program designed to teach mindfulness skills
Cognitive Processing Therapy
ACTIVE COMPARATORA group-administered PTSD treatment program.
Interventions
A validated 8-week group program that teaches mindfulness meditation
A validated group program of PTSD treatment, which focuses on cognitive processing.
Eligibility Criteria
You may qualify if:
- Veterans with current DSM-V diagnosis of PTSD
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David J. Kearney, MD
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2013
First Posted
October 29, 2013
Study Start
April 1, 2014
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
July 2, 2014
Record last verified: 2014-07