Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
MBSRforPTSD
Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
1 other identifier
interventional
50
1 country
1
Brief Summary
PTSD is a common consequence of war, for soldiers and civilians. PTSD results in hyperarousal, avoidance, numbing, and re-experiencing, causing persistent decreased quality of life. Mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health. Within health care, mindfulness is taught as an 8-week course called Mindfulness-Based Stress Reduction (MBSR). MBSR is unstudied for PTSD. We propose to assess the feasibility of MBSR as an intervention for PTSD, since it may affect hypervigilance, avoidance, and reactivity associated with this disorder. Specific Aims: Aim 1: Assess the feasibility of recruiting and retaining a sample of veterans with PTSD to complete a study protocol that involves randomization to usual care or usual care plus MBSR. Aim 2: Apply measures of PTSD symptom severity, depression and quality of life before and after randomization, to assess whether there is evidence of benefit and whether MBSR warrants further study for PTSD, and allow calculation of standardized effect sizes. Aim 3: Apply a validated measure of mindfulness before and after treatment. Aim 4: Explore the relationship between PTSD symptoms, mindfulness score, and frequency of meditation practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2008
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
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 10, 2009
CompletedFirst Posted
Study publicly available on registry
April 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedSeptember 24, 2010
September 1, 2010
1.2 years
April 10, 2009
September 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PTSD symptom score
baseline, after MBSR and 4 months later
Secondary Outcomes (1)
depression (PHQ9)
baseline, after MBSR and 4 months later
Study Arms (2)
MBSR
EXPERIMENTALAn 8-week course in mindfulness-based stress reduction (MBSR)
2
NO INTERVENTIONTreatment as usual
Interventions
Eligibility Criteria
You may qualify if:
- Must have PTSD
You may not qualify if:
- Active substance use
- Active suicidal ideations
- Borderline or antisocial personality disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
Related Publications (1)
Kearney DJ, McDermott K, Malte C, Martinez M, Simpson TL. Effects of participation in a mindfulness program for veterans with posttraumatic stress disorder: a randomized controlled pilot study. J Clin Psychol. 2013 Jan;69(1):14-27. doi: 10.1002/jclp.21911. Epub 2012 Aug 28.
PMID: 22930491DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Kearney, MD
VA Puget Sound Health Care System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 10, 2009
First Posted
April 13, 2009
Study Start
September 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
September 24, 2010
Record last verified: 2010-09