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

April 10, 2009
September 23, 2010
September 2008
December 2009   (final data collection date for primary outcome measure)
PTSD symptom score [ Time Frame: baseline, after MBSR and 4 months later ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00880152 on ClinicalTrials.gov Archive Site
depression (PHQ9) [ Time Frame: baseline, after MBSR and 4 months later ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study
Mindfulness-Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stress Disorders, Post-Traumatic
  • Depression
Behavioral: Mindfulness-based stress reduction
An 8-week course in mindfulness training
  • Experimental: MBSR
    An 8-week course in mindfulness-based stress reduction (MBSR)
    Intervention: Behavioral: Mindfulness-based stress reduction
  • No Intervention: 2
    Treatment as usual
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must have PTSD

Exclusion Criteria:

  • Active substance use
  • Active suicidal ideations
  • Borderline or antisocial personality disorder
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00880152
34622
No
David Kearney, M.D., VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Puget Sound Partners for Global Health
Principal Investigator: David Kearney, MD VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP