Meditation Interventions for Treatment of PTSD in Veterans (VMP)
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|ClinicalTrials.gov Identifier: NCT01548742|
Recruitment Status : Completed
First Posted : March 8, 2012
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic||Behavioral: Mindfulness-Based Stress Reduction (MBSR) Behavioral: Present-Centered Group Therapy (PCGT)||Not Applicable|
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.
- To evaluate rates of drop-out, compliance, and consumer satisfaction with MBSR.
- To evaluate acceptability and outcomes of treatment with veterans with mild traumatic brain injuries.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Meditation Interventions for Treatment of PTSD in Veterans|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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 Name: 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548742
|United States, Minnesota|
|VA Medical Center, Minneapolis|
|Minneapolis, Minnesota, United States, 55417|
|Principal Investigator:||Kelvin Lim, MD||Minneapolis VA Health Care System, Minneapolis, MN|