A Randomized Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans

Posttraumatic stress disorder (PTSD) is a common and debilitating anxiety condition that
affects up to 20% of war Veterans. PTSD is often a chronic problem for Veterans, affecting
reintegration into society, family and marital relationships, sleep, employment stability,
substance abuse rates, and risk for depression and suicide, among other areas. Although
several effective therapies exist to treat PTSD, research shows that up to half of patients
completing these treatments continue to have elevated symptoms indicating the important need
for developing additional treatment options.

In the current trial, we propose to test one such new treatment, specifically a meditation
practice known as Transcendental Meditation. The Transcendental Meditation (TM) program will
be compared to one of the best and most standard of PTSD therapies (Prolonged Exposure
therapy), and a educational control group. This study will recruit 210 War Veterans
clinically diagnosed with PTSD from the San Diego VA Healthcare System over a 4 year study
period.

The intervention period will be 3 months. Study participants will be randomized equally to
one of three study groups, either

1. Transcendental Meditation (TM) or

2. Cognitive Behavioral Therapy with Prolonged Exposure (CBT-PE) or

3. Educational control group.

The primary outcome will be scores on the Clinically Administered PTSD Scale (CAPS).

Secondary outcomes will includes scores on PTSD symptoms including depression, anger, mood
disturbance and quality of life.

Behavioral or lifestyle factors will also be measured including smoking, alcohol, and
non-described drug usage along with compliance with each treatment.

Physiological markers of stress and disease risk will include cortisol, blood pressure,
inflammatory markers and body mass.

If successful, these research findings will serve to provide key data on the feasibility and
efficacy of the TM program as an alternative therapy for PTSD. The results will serve to
inform policy decisions on the study and application of standardized and validated stress
reduction programs in veteran populations.

Inclusion Criteria:

1. Current medical diagnosis of PTSD

2. A symptom severity score of 45 or higher on the Clinically Administered PTSD Scale
(CAPS)

3. Three or more months since service-related trauma

4. If being treated with psychoactive medication, a stable regimen (no change in drugs or
dose) for at least 2 months before enrollment

5. Age: 18 years or older

6. Language: English literate -

Exclusion Criteria:

1. Current unstable or uncontrolled psychotic symptoms, mania or bipolar disorder 2.
Current suicidal or homicidal ideation 3. Moderate or greater cognitive impairment
indicated by chart diagnosis or observable cognitive difficulties 4. Having received
Prolonged Exposure therapy or having been instructed in Transcendental Meditation.