Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study (MBSRforPTSD)
Primary Purpose
Stress Disorders, Post-Traumatic, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based stress reduction
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring stress, mindfulness, trauma
Eligibility Criteria
Inclusion Criteria:
- Must have PTSD
Exclusion Criteria:
- Active substance use
- Active suicidal ideations
- Borderline or antisocial personality disorder
Sites / Locations
- VA Puget Sound Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MBSR
2
Arm Description
An 8-week course in mindfulness-based stress reduction (MBSR)
Treatment as usual
Outcomes
Primary Outcome Measures
PTSD symptom score
Secondary Outcome Measures
depression (PHQ9)
Full Information
NCT ID
NCT00880152
First Posted
April 10, 2009
Last Updated
September 23, 2010
Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
Puget Sound Partners for Global Health
1. Study Identification
Unique Protocol Identification Number
NCT00880152
Brief Title
Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
Acronym
MBSRforPTSD
Official Title
Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seattle Institute for Biomedical and Clinical Research
Collaborators
Puget Sound Partners for Global Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Depression
Keywords
stress, mindfulness, trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MBSR
Arm Type
Experimental
Arm Description
An 8-week course in mindfulness-based stress reduction (MBSR)
Arm Title
2
Arm Type
No Intervention
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based stress reduction
Intervention Description
An 8-week course in mindfulness training
Primary Outcome Measure Information:
Title
PTSD symptom score
Time Frame
baseline, after MBSR and 4 months later
Secondary Outcome Measure Information:
Title
depression (PHQ9)
Time Frame
baseline, after MBSR and 4 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have PTSD
Exclusion Criteria:
Active substance use
Active suicidal ideations
Borderline or antisocial personality disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kearney, MD
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22930491
Citation
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.
Results Reference
derived
Learn more about this trial
Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
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