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

NCT ID: NCT00880152

Last Updated: 2010-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Stress Disorders, Post-Traumatic Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MBSR

An 8-week course in mindfulness-based stress reduction (MBSR)

Group Type EXPERIMENTAL

Mindfulness-based stress reduction

Intervention Type BEHAVIORAL

An 8-week course in mindfulness training

2

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-based stress reduction

An 8-week course in mindfulness training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Must have PTSD

Exclusion Criteria

* Active substance use
* Active suicidal ideations
* Borderline or antisocial personality disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Puget Sound Partners for Global Health

UNKNOWN

Sponsor Role collaborator

Seattle Institute for Biomedical and Clinical Research

OTHER

Sponsor Role lead

Responsible Party

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VA Puget Sound Health Care System

Principal Investigators

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David Kearney, MD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System

Locations

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VA Puget Sound Health Care System

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22930491 (View on PubMed)

Other Identifiers

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34622

Identifier Type: -

Identifier Source: org_study_id