Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study

Not Applicable

Completed

• Conditions: Stress Disorders, Post-Traumatic; Depression
• Interventions: Behavioral: Mindfulness-based stress reduction

• Registration Number: NCT00880152
• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-10
• Study First Posted: 2009-04-13
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-23
• Last Update Posted: 2010-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Must have PTSD

Exclusion Criteria

• Active substance use
• Active suicidal ideations
• Borderline or antisocial personality disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MBSR	Mindfulness-based stress reduction	An 8-week course in mindfulness-based stress reduction (MBSR)

Primary Outcome Measures

Name	Time	Method
PTSD symptom score	baseline, after MBSR and 4 months later

Secondary Outcome Measures

Name	Time	Method
depression (PHQ9)	baseline, after MBSR and 4 months later

Trial Locations

Locations (1)

VA Puget Sound Health Care System; 🇺🇸 Seattle, Washington, United States