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Meditation Interventions for Treatment of PTSD in Veterans (VMP)

This study is currently recruiting participants.
Verified February 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01548742
First received: March 5, 2012
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Stress Disorders, Post-Traumatic
 Behavioral: Mindfulness-Based Stress Reduction (MBSR)
Behavioral: Present-Centered Group Therapy (PCGT)
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Meditation Interventions for Treatment of PTSD in Veterans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Posttraumatic stress disorder (PTSD) checklist (PCL) [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    PTSD symptoms


Secondary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    PTSD diagnosis


Estimated Enrollment: 180
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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 Name: MBSR
Active Comparator: Arm 2
Present-Centered Group Therapy (PCGT)
 Behavioral: Present-Centered Group Therapy (PCGT)
Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.

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.
  Eligibility

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

Inclusion Criteria:

  1. Male or female veterans who are 18 years or older.
  2. Must meet current DSM-IV criteria for PTSD based on the Clinician Administered PTSD Scale (CAPS).
  3. If taking psychoactive medications, must be on a stable regime for 8 weeks or more.

Exclusion Criteria:

  1. Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment.
  2. Meets current DSM-IV criteria for substance dependence (except nicotine or caffeine), bipolar affective disorder, schizophrenia or any psychotic disorder.
  3. Has unstable or serious medical illness, including history of stroke, seizure disorder, or unstable cardiac disease, that would interfere with participation in treatment.
  4. Severe cognitive impairment or moderate/severe traumatic brain injury.
  5. Unable to comprehend or communicate in English.
  6. Unwilling to accept random assignment or unwilling to refrain from participating in other active forms of psychotherapy during 8-week treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548742

Contacts
Contact: Doris M Clancy, MA (612) 467-5203 Doris.Clancy@va.gov
Contact: Kelvin Lim, MD (612) 467-3323 kolim@umn.edu

Locations
United States, Minnesota
VA Medical Center, Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Doris M Clancy, MA     612-467-5203     Doris.Clancy@va.gov    
Contact: Kelvin Lim, MD     (612) 467-3323     kolim@umn.edu    
Principal Investigator: Kelvin Lim, MD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Kelvin Lim, MD Minneapolis VA Health Care System, Minneapolis, MN
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01548742     History of Changes
Other Study ID Numbers: SPLE-012-11S, CX-11-012
Study First Received: March 5, 2012
Last Updated: February 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Meditation

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013