Meditation Interventions for Treatment of PTSD in Veterans (VMP)

November 4, 2015 updated by: VA Office of Research and Development
Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder which results in serious impairments in interpersonal, occupational and social functioning. Effective treatments are available for PTSD but they do not work for everyone. Alternative treatments are needed to help those veterans not helped by currently available treatments. Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on mindfulness meditation. MBSR has been found to be effective in helping people with problems with pain and anxiety. MBSR has not yet been studied in veterans with PTSD. The proposed study will compare MBSR with a standard psychotherapy treatment in veterans with PTSD. This research is relevant to Veterans' health because of the need to develop alternative treatments for veterans with PTSD who have not responded to currently available treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder associated with high rates of chronicity, poor quality of life, and severe impairments in interpersonal, occupational, and social functioning. While evidence-based psychotherapies for treatment of PTSD have been developed and disseminated within the VA system, no treatment has shown universal effectiveness and there have been great concerns about attenuated treatment response and elevated treatment drop out in veteran populations. The evaluation of alternative treatment modalities for veterans with PTSD is therefore an important priority. The Minneapolis VA Health Care System (MVAHCS) has taught Mindfulness Based Stress Reduction (MBSR), a group-based intervention focused on mindfulness meditation, to veteran clinical populations since 2001, and pilot data from veterans diagnosed with PTSD is promising. Despite support for the application of MBSR to other mental health and physical problems, MBSR has not been systematically evaluated as a treatment for PTSD. Moreover, the existing literature on MBSR is limited by methodological weaknesses. If shown to be efficacious through scientifically sound trials, MSBR may offer an effective, acceptable, and tolerable intervention for veterans suffering PTSD who are unable to engage in or complete traditional exposure-based therapies. The primary goal of this proposal is to conduct a methodologically rigorous randomized controlled trial (RCT) of MBSR in treating PTSD among veterans, examining both symptom outcomes and subsequent health services utilization. Given our compelling pilot data, we propose initial steps to evaluate putative mechanisms of change (self-report and electrophysiology markers, i.e., EEG) through which MBSR may relate to PTSD symptom improvements, and to examine the acceptability of MBSR to the veteran population.

The MVAHCS and the assembled team combines expertise in PTSD treatment and research, clinical trials, and neuroscience, with clinical expertise in MBSR and compelling pilot data to support the feasibility and scope of the current project. The efficacy of MBSR will be examined relative to present-centered group therapy (PCGT), a non-specific therapeutic comparison group. Veterans diagnosed with PTSD will be randomized to MBSR or PCGT for 9 weeks. Each intervention will be delivered in group format following manualization by trained clinicians receiving expert supervision. Treatment integrity will be independently monitored. Assessment of clinical outcomes post-treatment and 2 months follow-up will be independently evaluated. Putative mechanisms of mindfulness meditation will be assessed using self-report and electrophysiology markers. We have the following aims:

Primary Aim 1: To evaluate the efficacy of MBSR as a treatment for PTSD in veterans compared to PCGT over 9-weeks of treatment and 2-month follow-up.

Secondary Aim 1: To identify potential treatment-based predictors of PTSD outcomes.

Secondary Aim 2: To identify differences in subsequent VA health services utilization among veterans across treatment conditions.

Exploratory Aims:

  1. To evaluate rates of drop-out, compliance, and consumer satisfaction with MBSR.
  2. To evaluate acceptability and outcomes of treatment with veterans with mild traumatic brain injuries.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • VA Medical Center, Minneapolis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female veterans who are 18 years or older.
  • Must meet current DSM-IV criteria for PTSD based on the Clinician Administered PTSD Scale (CAPS) or have a PTSD Checklist (PCL) score between 40 and 60.
  • If taking psychoactive medications, must be on a stable regime for 8 weeks or more.

Exclusion Criteria:

  • Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment.
  • Current substance dependence (not in sustained remission), current or recent (within past 6 months) manic episode, or active psychosis. To be eligible, if veteran has current diagnosis of bipolar disorder, there is evidence that illness has been stable for at least 6 months on medication. Has unstable or serious medical illness, including history of stroke, seizure disorder, or unstable cardiac disease that would interfere with participation in treatment.
  • Severe cognitive impairment or moderate/severe traumatic brain injury.
  • Unable to comprehend or communicate in English.
  • Unwilling to accept random assignment or unwilling to refrain from participating in other active forms of psychotherapy during 8-week treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1: Mindfulness-Based Stress Reduction (MBSR)
Mindfulness-Based Stress Reduction (MBSR)
Behavioral: Mindfulness-Based Stress Reduction (MBSR)
Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
Other Names:
  • MBSR
ACTIVE_COMPARATOR: Arm 2: Present-Centered Group Therapy (PCGT)
Present-Centered Group Therapy (PCGT)
Behavioral: Present-Centered Group Therapy (PCGT)
Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up
Time Frame: Baseline, Weeks 3, 6, 9 and 17
The PCL is a valid and reliable measure of PTSD symptoms. Score range from 17-85; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the PCL.
Baseline, Weeks 3, 6, 9 and 17

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up
Time Frame: Baseline, Weeks 9 and 17
The CAPS is a valid and reliable measure of PTSD symptom severity. Score range from 0-136; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 10 or more points on the CAPS.
Baseline, Weeks 9 and 17
Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up
Time Frame: Baseline, Weeks 9 and 17
The PHQ-9 is a valid and reliable measure of depression symptom severity. Score range from 0-27; higher scores indicate more severe symptoms. The minimal clinically important difference for self-reported PTSD symptom severity is a reduction of 5 or more points on the PHQ-9.
Baseline, Weeks 9 and 17

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL
Time Frame: Weeks 9 and 17
% of participants with clinically significant improvement in self-reported PTSD symptoms defined as a reduction of 10 points or more on the PCL.
Weeks 9 and 17
Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS)
Time Frame: Weeks 9 and 17
% of participants with clinically significant improvement in interviewer-rated PTSD symptom severity defined as a reduction of 10 points or more on the CAPS.
Weeks 9 and 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Kelvin Lim, MD, Minneapolis VA Health Care System, Minneapolis, MN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 5, 2012

First Posted (ESTIMATE)

March 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 10, 2015

Last Update Submitted That Met QC Criteria

November 4, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPLE-012-11S
  • CX-11-012 (OTHER_GRANT: VA Clinical Science Research & Development (CSR&D))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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