Clinical trial NCT01865123: A Randomized Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans
Official title: A Randomized Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: post-traumatic stress disorder
transcendental meditation
cognitive behavioral therapy
prolonged exposure
Lead sponsor: United States Department of Defense
Sponsor class: FED
Collaborators: name: San Diego Veterans Healthcare System
name: Maharishi University of Management Research Institute
name: University of California, San Diego
First posted: 2013-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: Clinically Administered PTSD Scale (CAPS)
timeFrame: 3 months
Secondary outcomes:
measure: Self-Report Symptoms of PTSD
timeFrame: 3 months
Other outcomes:
measure: Behavioral Measures
timeFrame: 3 months
measure: Biomarkers of Stress
timeFrame: 3 months
measure: Treatment Adherence
timeFrame: 3 months
Locations:
city: La Jolla
country: United States
facility: San Diego VA Healthcare System
state: California
Study officials:
affiliation: Maharishi University of Management Research Institute
name: Sanford I Nidich, EdD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego VA Healthcare System
name: Thomas Rutledge, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rutledge T, Nidich S, Schneider RH, Mills PJ, Salerno J, Heppner P, Gomez MA, Gaylord-King C, Rainforth M. Design and rationale of a comparative effectiveness trial evaluating transcendental meditation against established therapies for PTSD. Contemp Clin Trials. 2014 Sep;39(1):50-6. doi: 10.1016/j.cct.2014.07.005. Epub 2014 Jul 25.
citation: Nidich S, Mills PJ, Rainforth M, Heppner P, Schneider RH, Rosenthal NE, Salerno J, Gaylord-King C, Rutledge T. Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: a randomised controlled trial. Lancet Psychiatry. 2018 Dec;5(12):975-986. doi: 10.1016/S2215-0366(18)30384-5. Epub 2018 Nov 15.