An interventional study of Mindfulness-Based Stress Reduction (MBSR) and Present-Centered Group Therapy (PCGT) in Stress Disorders, Post-Traumatic, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-10.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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:
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This study's enrollment of 116 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
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Exclusion Criteria:
Mindfulness-Based Stress Reduction (MBSR)
Behavioral: Mindfulness-Based Stress Reduction (MBSR)
Present-Centered Group Therapy (PCGT)
Behavioral: Present-Centered Group Therapy (PCGT)
Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
Also known as: MBSR
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
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.
Time frame: Baseline, Weeks 3, 6, 9 and 17
PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up
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.
Time frame: 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
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.
Time frame: Baseline, Weeks 9 and 17
Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL
% of participants with clinically significant improvement in self-reported PTSD symptoms defined as a reduction of 10 points or more on the PCL.
Time frame: Weeks 9 and 17
Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS)
% of participants with clinically significant improvement in interviewer-rated PTSD symptom severity defined as a reduction of 10 points or more on the CAPS.
Time frame: Weeks 9 and 17
Participants were recruited through flyers posted in targeted clinics and clinical referrals at the Minneapolis VA Medical Center.
| Milestone | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) |
|---|---|---|
| Started | 58 | 58 |
| Completed | 45 | 54 |
| Not completed | 13 | 4 |
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.
| units on a scale | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) |
|---|---|---|
| Baseline PCL | 63.6 (60.6 to 66.7) | 58.8 (55.7 to 61.8) |
| Week 3 PCL | 63.9 (60.8 to 67.0) | 61.7 (58.6 to 64.8) |
| Wee 6 PCL | 61.3 (58.1 to 64.4) | 60.7 (57.6 to 63.8) |
| Week 9 PCL | 55.7 (52.6 to 58.9) | 55.8 (52.7 to 58.9) |
| Week 17 PCL | 54.4 (51.2 to 57.6) | 56.0 (52.9 to 59) |
% of participants with clinically significant improvement in self-reported PTSD symptoms defined as a reduction of 10 points or more on the PCL.
| percentage clinical responders | Arm 1: Mindfulness Based Stress Reduction (MBSR) | Arm 2: Present Centered Group Therapy (PCGT) |
|---|---|---|
| % responders, Week 9 | 36.5 (24 to 49) | 22.8 (10.9 to 34.7) |
| % responders, Week 17 | 48.9 (35.1 to 62.8) | 28.1 (15.5 to 40.6) |
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.
| units on a scale | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) |
|---|---|---|
| Baseline CAPS | 69.9 (65.0 to 74.8) | 62.5 (57.6 to 67.4) |
| Week 9 CAPS | 56.3 (51.0 to 61.5) | 51.7 (46.5 to 56.8) |
| Week 17 CAPS | 49.8 (44.3 to 55.3) | 50.6 (45.4 to 55.8) |
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.
| units on a scale | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) |
|---|---|---|
| Baseline PHQ-9 | 15.5 (13.9 to 17.0) | 14.6 (13.1 to 16.2) |
| Week 9 PHQ-9 | 13.6 (12.0 to 15.1) | 13.9 (12.3 to 15.4) |
| Week 17 PHQ-9 | 13.3 (11.7 to 15.0) | 13.8 (12.2 to 15.4) |
% of participants with clinically significant improvement in interviewer-rated PTSD symptom severity defined as a reduction of 10 points or more on the CAPS.
| percentage clinical responders | Arm 1: Mindfulness Based Stress Reduction (MBSR) | Arm 2: Present Centered Group Therapy (PCGT) |
|---|---|---|
| % responders, Week 9 | 63.5 (49.8 to 77.1) | 49.1 (36.1 to 62.1) |
| % responders, Week 17 | 66.7 (52.1 to 81.2) | 54.5 (41.4 to 67.7) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | — | 1/58 (1.7%) | 0/58 (0%) |
| Arm 2: Present-Centered Group Therapy (PCGT) | — | 2/58 (3.4%) | 0/58 (0%) |
| Event | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) |
|---|---|---|
| Suicide Attempt or worsening of symptomsPsychiatric disorders | 1/58 | 1/58 |
| Crushed by falling treeGeneral disorders | 0/58 | 1/58 |
| Age, Continuous(years) | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) | Total |
|---|---|---|---|
| Mean | 57.6 ± 10.4 | 59.4 ± 9.2 | 58.5 ± 9.8 |
| Sex: Female, Male(Participants) | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) | Total |
|---|---|---|---|
| Female | 12 | 6 | 18 |
| Male | 46 | 52 | 98 |
| Race/Ethnicity, Customized(participants) | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) | Total |
|---|---|---|---|
| White | 47 | 50 | 97 |
| Black | 3 | 6 | 9 |
| Other | 2 | 2 | 4 |
| Mixed | 6 | 0 | 6 |
| Service Era(participants) | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) | Total |
|---|---|---|---|
| OEF/OIF | 6 | 5 | 11 |
| Gulf War | 9 | 8 | 17 |
| Vietnam War | 41 | 45 | 86 |
| Other | 2 | 0 | 2 |
| Lifetime trauma exposure(No. of events) | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) | Total |
|---|---|---|---|
| Mean | 7.9 ± 3.3 | 7.5 ± 3.0 | 7.7 ± 3.1 |
| Lifetime trauma exposure event type(participants) | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) | Total |
|---|---|---|---|
| Combat exposure | 39 | 47 | 86 |
| Sexual trauma | 21 | 11 | 32 |
| Physical assault | 39 | 37 | 76 |
| Disaster exposure | 25 | 25 | 50 |
| Serious accident | 38 | 36 | 74 |
| Life-threatening illness or injury | 34 | 33 | 67 |
| Other traumatic event | 55 | 55 | 110 |
| PTSD diagnosis(participants) | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) | Total |
|---|---|---|---|
| Full PTSD criteria | 57 | 56 | 113 |
| Subthreshold PTSD | 1 | 2 | 3 |
| Comorbid mood disorder(participants) | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) | Total |
|---|---|---|---|
| Number | 26 | 23 | 49 |
4 further baseline measures are reported on the registry.
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic→
VA Office of Research and Development