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

This study has been completed.
Sponsor:
Collaborator:
Puget Sound Partners for Global Health
Information provided by:
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT00880152
First received: April 10, 2009
Last updated: September 23, 2010
Last verified: September 2010
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:
  • PTSD symptom score [ Time Frame: baseline, after MBSR and 4 months later ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • depression (PHQ9) [ Time Frame: baseline, after MBSR and 4 months later ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have PTSD

Exclusion Criteria:

  • Active substance use
  • Active suicidal ideations
  • Borderline or antisocial personality disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880152

Locations
United States, Washington
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
  More Information

No publications provided by Seattle Institute for Biomedical and Clinical Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David Kearney, M.D., VA Puget Sound Health Care System
ClinicalTrials.gov Identifier: NCT00880152     History of Changes
Other Study ID Numbers: 34622
Study First Received: April 10, 2009
Last Updated: September 23, 2010
Health Authority: United States: Federal Government

Keywords provided by Seattle Institute for Biomedical and Clinical Research:
stress
mindfulness
trauma

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
 Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on May 16, 2013