Meditation Interventions for Treatment of PTSD in Veterans

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.

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.