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Completed

NCT Number: NCT01865123

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

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.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego VA Healthcare System

La Jolla, California, United States

About this study

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).

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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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Treatment and study plan

Transcendental Meditation

Behavioral

A standard 7 step course will be offered including an introductory and preparatory lectures, personal one-on-one instruction with a certified TM teacher followed by 3 consecutive days of classes on how to meditate correctly and effortlessly, how to understand mechanisms of stress release and sequential development to higher levels of human consciousness and enjoying ones full potential. Followup meetings will provide checking of TM practice, sharing of group experiences with the TM practice and knowledge to motivate and inspire continued regularity with the practice. The certified TM instructor will have experience with PTSD in this veteran population.

Other names: meditation, mantra meditation, stress management

Prolonged Exposure

Behavioral

Prolonged exposure therapy, a specific form of cognitive behavioral therapy, is considered the standard psychotherapy treatment for PTSD . The delivery of PE will be by a trained study therapist. There will be 16 individual sessions provided to each participant. Homework will include relaxation and breathing exercises and anxiety diaries.

Other names: Cognitive Behavioral Therapy

Educational Control

Behavioral

This group will receive group-administered didactic health education specific to the PTSD veterans population. It will include emphasis on healthy lifestyle changes to promote more positive mental and physical health. The classes will be matched with the TM and PE interventions to control for time, instructor attention and other non-specific factors.

Other names: Health Education

Primary outcomes

  1. 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

  1. Self-Report Symptoms of PTSD

    Time frame: 3 months

    The PTSD Checklist- Military version (PCL-M) will assess PTSD symptoms in response to stressful military experiences.

    The Patient Health Questionnaire (PHQ)-9 will be used to evaluate clinical depression.

    The Profile of Mood States (POMS - will be used to evaluate total mood disturbance (TMD) main scale and tension/anxiety, depression/dejection, and anger/hostility subscales.

    The Social Support Questionnaire (SSQ) will be used to evaluate level of social support.

    The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form will used to assess overall quality of life.

Other outcomes

  1. Behavioral Measures

    Time frame: 3 months

    For substance usage, participants will be evaluated by the Weekly Recall (WR) method on alcohol, non-prescribed drugs, and smoking

  2. Biomarkers of Stress

    Time frame: 3 months

    Blood Pressure will be measured three times with a mercury sphygmomanometer after five minutes rest. Three readings will be taken one minute apart. The latter two will be averaged for clinic visit mean.

    Participants will complete a 24-hour urine collection for catecholamine levels as a marker of chronic sympathetic nervous system activation and cortisol as a marker for hypothalamic-pituitary-adrenal (HPA) axis activation.

    Inflammatory biomarkers relevant to PTSD and cardiovascular disease will be assayed including C-Reactive Protein(CRP), Tumor Necrosis Factor(TNF-a), and Interleukin-6(IL-6).

  3. Treatment Adherence

    Time frame: 3 months

    Adherence with the study interventions will be assessed through multiple measures in the two study groups. Adherence with health education and the stress reduction practice will be measured by: 1) daily home practice logs; 2) basic and follow-up meetings attended; and 3) random phone calls to participants by staff to determine recent practice of participants' respective programs. The Patient Satisfaction Questionnaire will also be used to evaluate the TM and CBT-PE programs.

Sponsors and collaborators

Lead sponsor

United States Department of Defense

Fed

Collaborators

  • Maharishi University of Management Research Institute
  • San Diego Veterans Healthcare System
  • University of California, San Diego

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 30, 2013
Registry last updated
Nov 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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