A Randomized Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Clinically Administered PTSD Scale (CAPS)
Study Overview
Brief Summary
The purpose of this study is to compare the effectiveness of the Transcendental Meditation (TM) program to the more standard Cognitive Behavioral Therapy with Prolonged Exposure (CBT-PE) in treating posttraumatic stress disorder (PTSD) in war Veterans over a three month treatment period.
Detailed Description
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
- Transcendental Meditation (TM) or
- Cognitive Behavioral Therapy with Prolonged Exposure (CBT-PE) or
- Educational control group.
The primary outcome will be scores on the Clinically Administered PTSD Scale (CAPS).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Current medical diagnosis of PTSD
- •A symptom severity score of 45 or higher on the Clinically Administered PTSD Scale (CAPS)
- •Three or more months since service-related trauma
- •If being treated with psychoactive medication, a stable regimen (no change in drugs or dose) for at least 2 months before enrollment
- •Age: 18 years or older
- •Language: English literate -
Exclusion Criteria
- •Current unstable or uncontrolled psychotic symptoms, mania or bipolar disorder
- •Current suicidal or homicidal ideation
- •Moderate or greater cognitive impairment indicated by chart diagnosis or observable cognitive difficulties
- •Having received Prolonged Exposure therapy or having been instructed in Transcendental Meditation.
Arms & Interventions
Transcendental Meditation
TM is a simple, natural, effortless mental technique practiced with eyes closed sitting for 20 minutes twice a day. This allows the practitioner to experience lesser excited levels of the mind and correspondingly greater degrees of physical relaxation. TM is a traditional meditation technique that has its origin in the ancient Vedic tradition of India.
Intervention: Transcendental Meditation (Behavioral)
Prolonged Exposure
Prolonged Exposure (PE) is a specialized type of Cognitive Behavorial Therapy employing a manualized, trauma-focused behavioral treatment for PTSD and is based on exposure principles and emotional processing theory.
Intervention: Prolonged Exposure (Behavioral)
Educational Control
Didactic based instructional classes will provide health education which will include the benefits of proper diet, exercise, and reducing smoking and alcohol. No stress management techniques will be taught.
Intervention: Educational control (Behavioral)
Outcomes
Primary Outcomes
Clinically Administered PTSD Scale (CAPS)
Time Frame: 3 months
This scale is currently the gold standard for assessing the severity of post-traumatic stress disorder (PTSD) using a face-to-face interview with the patient and a professionally trained medical/psychiatric administrator.
Secondary Outcomes
- Self-Report Symptoms of PTSD(3 months)
Investigators
Sanford Nidich, Ed.D.
Associate Director
Maharishi International University