Stress Disorders, Post-Traumatic
Conditions
Keywords
Meditation
Brief summary
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.
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.
Interventions
BEHAVIORALMindfulness-Based Stress Reduction (MBSR)
Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
BEHAVIORALPresent-Centered Group Therapy (PCGT)
Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through flyers posted in targeted clinics and clinical referrals at the Minneapolis VA Medical Center.
Pre-assignment details
Participants completed a 5-hour eligibility and baseline assessment that included a structured clinical interview and self-report measures. Randomization occurred for those meeting study inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation. | 58 |
| Arm 2: Present-Centered Group Therapy (PCGT) Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems. | 58 |
| Total | 116 |
Baseline characteristics
| Characteristic | Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Arm 2: Present-Centered Group Therapy (PCGT) | Total |
|---|---|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 10.4 | 59.4 years STANDARD_DEVIATION 9.2 | 58.5 years STANDARD_DEVIATION 9.8 |
| Comorbid mood disorder | 26 participants | 23 participants | 49 participants |
| Duration of previous mental health care | 69.0 months STANDARD_DEVIATION 53.3 | 63.9 months STANDARD_DEVIATION 45.2 | 66.5 months STANDARD_DEVIATION 9.2 |
| Lifetime trauma exposure | 7.9 No. of events STANDARD_DEVIATION 3.3 | 7.5 No. of events STANDARD_DEVIATION 3 | 7.7 No. of events STANDARD_DEVIATION 3.1 |
| Lifetime trauma exposure event type Combat exposure | 39 participants | 47 participants | 86 participants |
| Lifetime trauma exposure event type Disaster exposure | 25 participants | 25 participants | 50 participants |
| Lifetime trauma exposure event type Life-threatening illness or injury | 34 participants | 33 participants | 67 participants |
| Lifetime trauma exposure event type Other traumatic event | 55 participants | 55 participants | 110 participants |
| Lifetime trauma exposure event type Physical assault | 39 participants | 37 participants | 76 participants |
| Lifetime trauma exposure event type Serious accident | 38 participants | 36 participants | 74 participants |
| Lifetime trauma exposure event type Sexual trauma | 21 participants | 11 participants | 32 participants |
| Number of participants receiving 8 or more therapy sessions in PTSD or mental health clinics | 19 participants | 24 participants | 43 participants |
| PTSD diagnosis Full PTSD criteria | 57 participants | 56 participants | 113 participants |
| PTSD diagnosis Subthreshold PTSD | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Black | 3 participants | 6 participants | 9 participants |
| Race/Ethnicity, Customized Mixed | 6 participants | 0 participants | 6 participants |
| Race/Ethnicity, Customized Other | 2 participants | 2 participants | 4 participants |
| Race/Ethnicity, Customized White | 47 participants | 50 participants | 97 participants |
| Service Era Gulf War | 9 participants | 8 participants | 17 participants |
| Service Era OEF/OIF | 6 participants | 5 participants | 11 participants |
| Service Era Other | 2 participants | 0 participants | 2 participants |
| Service Era Vietnam War | 41 participants | 45 participants | 86 participants |
| Sex: Female, Male Female | 12 Participants | 6 Participants | 18 Participants |
| Sex: Female, Male Male | 46 Participants | 52 Participants | 98 Participants |
| Taking psychotropic medication | 51 participants | 49 participants | 100 participants |
| Total number of psychotherapy mental health visits | 13.2 sessions STANDARD_DEVIATION 28.3 | 14.6 sessions STANDARD_DEVIATION 29.2 | 13.9 sessions STANDARD_DEVIATION 28.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 58 |
| serious Total, serious adverse events | 1 / 58 | 2 / 58 |
Outcome results
Primary
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
Population: Intent to treat population (all participants randomized to treatment).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up | Week 3 PCL | 63.9 units on a scale |
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up | Week 9 PCL | 55.7 units on a scale |
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up | Wee 6 PCL | 61.3 units on a scale |
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up | Week 17 PCL | 54.4 units on a scale |
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up | Baseline PCL | 63.6 units on a scale |
| Arm 2: Present-Centered Group Therapy (PCGT) | PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up | Week 17 PCL | 56.0 units on a scale |
| Arm 2: Present-Centered Group Therapy (PCGT) | PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up | Baseline PCL | 58.8 units on a scale |
| Arm 2: Present-Centered Group Therapy (PCGT) | PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up | Week 3 PCL | 61.7 units on a scale |
| Arm 2: Present-Centered Group Therapy (PCGT) | PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up | Wee 6 PCL | 60.7 units on a scale |
| Arm 2: Present-Centered Group Therapy (PCGT) | PTSD Symptoms on the PTSD Checklist (PCL) at Baseline, During Treatment, After Treatment and at 2-Month Follow-up | Week 9 PCL | 55.8 units on a scale |
Secondary
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
Population: Intent to treat population (all participants randomized to treatment).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up | Baseline PHQ-9 | 15.5 units on a scale |
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up | Week 9 PHQ-9 | 13.6 units on a scale |
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up | Week 17 PHQ-9 | 13.3 units on a scale |
| Arm 2: Present-Centered Group Therapy (PCGT) | Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up | Week 17 PHQ-9 | 13.8 units on a scale |
| Arm 2: Present-Centered Group Therapy (PCGT) | Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up | Baseline PHQ-9 | 14.6 units on a scale |
| Arm 2: Present-Centered Group Therapy (PCGT) | Depression Symptom Severity on the Patient Health Questionnaire-9 (PHQ-9) at Baseline, After Treatment, and at 2-Month Follow-up | Week 9 PHQ-9 | 13.9 units on a scale |
Secondary
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
Population: Intent to treat population (all participants randomized to treatment).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up | Baseline CAPS | 69.9 units on a scale |
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up | Week 9 CAPS | 56.3 units on a scale |
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up | Week 17 CAPS | 49.8 units on a scale |
| Arm 2: Present-Centered Group Therapy (PCGT) | PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up | Baseline CAPS | 62.5 units on a scale |
| Arm 2: Present-Centered Group Therapy (PCGT) | PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up | Week 9 CAPS | 51.7 units on a scale |
| Arm 2: Present-Centered Group Therapy (PCGT) | PTSD Symptom Severity on the Clinician Administered PTSD Scale (CAPS) at Baseline, After Treatment, and at 2-Month Follow-up | Week 17 CAPS | 50.6 units on a scale |
Other Pre-specified
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
Population: Intent to treat analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS) | % responders, Week 9 | 63.5 percentage clinical responders |
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS) | % responders, Week 17 | 66.7 percentage clinical responders |
| Arm 2: Present-Centered Group Therapy (PCGT) | Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS) | % responders, Week 9 | 49.1 percentage clinical responders |
| Arm 2: Present-Centered Group Therapy (PCGT) | Clinically Significant Improvement in Clinician Administered PTSD Scale (CAPS) | % responders, Week 17 | 54.5 percentage clinical responders |
Other Pre-specified
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
Population: Intent to treat analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL | % responders, Week 9 | 36.5 percentage clinical responders |
| Arm 1: Mindfulness-Based Stress Reduction (MBSR) | Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL | % responders, Week 17 | 48.9 percentage clinical responders |
| Arm 2: Present-Centered Group Therapy (PCGT) | Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL | % responders, Week 9 | 22.8 percentage clinical responders |
| Arm 2: Present-Centered Group Therapy (PCGT) | Clinically Significant Improvement in Self-reported PTSD Symptoms as Measured by the PCL | % responders, Week 17 | 28.1 percentage clinical responders |