Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study (MBSRforPTSD)
| Tracking Information | |||||
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| First Received Date ICMJE | April 10, 2009 | ||||
| Last Updated Date | September 23, 2010 | ||||
| Start Date ICMJE | September 2008 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
PTSD symptom score [ Time Frame: baseline, after MBSR and 4 months later ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00880152 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
depression (PHQ9) [ Time Frame: baseline, after MBSR and 4 months later ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study | ||||
| Official Title ICMJE | Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Mindfulness-based stress reduction
An 8-week course in mindfulness training |
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| Study Arm (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00880152 | ||||
| Other Study ID Numbers ICMJE | 34622 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | David Kearney, M.D., VA Puget Sound Health Care System | ||||
| Study Sponsor ICMJE | Seattle Institute for Biomedical and Clinical Research | ||||
| Collaborators ICMJE | Puget Sound Partners for Global Health | ||||
| Investigators ICMJE |
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| Information Provided By | Seattle Institute for Biomedical and Clinical Research | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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