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

• Sponsor: Seattle Institute for Biomedical and Clinical Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT00880152
• Collaborator: Puget Sound Partners for Global Health (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 3.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post-Traumatic; Depression	Behavioral: Mindfulness-based stress reduction	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MBSR An 8-week course in mindfulness-based stress reduction (MBSR)	Behavioral: Mindfulness-based stress reduction; An 8-week course in mindfulness training
No Intervention: 2 Treatment as usual

Outcome Measures

Primary Outcome Measures

1. PTSD symptom score [baseline, after MBSR and 4 months later]

Secondary Outcome Measures

1. depression (PHQ9) [baseline, after MBSR and 4 months later]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Must have PTSD

Exclusion Criteria:

• Active substance use

• Active suicidal ideations

• Borderline or antisocial personality disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Puget Sound Health Care System	Seattle	Washington	United States	98108

Sponsors and Collaborators

• Seattle Institute for Biomedical and Clinical Research
• Puget Sound Partners for Global Health

Investigators

• Principal Investigator: David Kearney, MD, VA Puget Sound Health Care System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00880152
• Other Study ID Numbers: 34622
• First Posted: Apr 13, 2009
• Last Update Posted: Sep 24, 2010
• Last Verified: Sep 1, 2010

• Keywords provided by , ,: stress; mindfulness; trauma
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Sep 24, 2010