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| Sponsors and Collaborators: |
Seattle Institute for Biomedical and Clinical Research Puget Sound Partners for Global Health |
|---|---|
| Information provided by: | Seattle Institute for Biomedical and Clinical Research |
| ClinicalTrials.gov Identifier: | NCT00880152 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Stress Disorders, Post-Traumatic Depression |
Behavioral: Mindfulness-based stress reduction |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study |
| Estimated Enrollment: | 50 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | November 2009 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
MBSR: Experimental
An 8-week course in mindfulness-based stress reduction (MBSR)
|
Behavioral: Mindfulness-based stress reduction
An 8-week course in mindfulness training
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2: No Intervention
Treatment as usual
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Michelle Martinez | 206-277-1721 | michelle.martinez4@va.gov |
| United States, Washington | |
| VA Puget Sound Health Care System | Recruiting |
| Seattle, Washington, United States, 98108 | |
| Contact: Michelle Martinez 206-277-1721 michelle.martinez4@va.gov | |
| Principal Investigator: David J Kearney, MD | |
| Principal Investigator: | David Kearney, MD | Puget Sound Veterans Administration Health Care System |
More Information
| Responsible Party: | VA Puget Sound Health Care System ( David Kearney, M.D. ) |
| Study ID Numbers: | 34622 |
| Study First Received: | April 10, 2009 |
| Last Updated: | April 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00880152 History of Changes |
| Health Authority: | United States: Federal Government |
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stress mindfulness trauma |
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Depression Anxiety Disorders Mental Disorders Wounds and Injuries Stress Disorders, Post-Traumatic |
Stress Depressive Disorder Stress Disorders, Traumatic Behavioral Symptoms |
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Pathologic Processes Disease Depression Anxiety Disorders Mental Disorders |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic Behavioral Symptoms |
