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Completed

NCT Number: NCT00880152

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have PTSD

Exclusion criteria

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

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

An 8-week course in mindfulness training

Primary outcomes

  1. PTSD symptom score

    Time frame: baseline, after MBSR and 4 months later

Secondary outcomes

  1. depression (PHQ9)

    Time frame: baseline, after MBSR and 4 months later

Sponsors and collaborators

Lead sponsor

Seattle Institute for Biomedical and Clinical Research

Other

Collaborators

  • Puget Sound Partners for Global Health

Registry information

Official study title

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

Acronym: MBSRforPTSD

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 13, 2009
Registry last updated
Sep 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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