Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01865123
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : November 26, 2018
Sponsor:
Collaborators:
San Diego Veterans Healthcare System
Maharishi University of Management Research Institute
University of California, San Diego
Information provided by (Responsible Party):
Sanford Nidich, Ed.D., Maharishi University of Management

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.

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Behavioral: Transcendental Meditation Behavioral: Prolonged Exposure Behavioral: Educational control Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans
Study Start Date : June 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Transcendental Meditation
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 Name: meditation, mantra meditation, stress management

Active Comparator: 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.
Behavioral: Prolonged Exposure
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 Name: Cognitive Behavioral Therapy

Placebo Comparator: 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.
Behavioral: Educational control
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 Name: Health Education




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865123


Locations
Layout table for location information
United States, California
San Diego VA Healthcare System
La Jolla, California, United States
Sponsors and Collaborators
United States Department of Defense
San Diego Veterans Healthcare System
Maharishi University of Management Research Institute
University of California, San Diego
Investigators
Layout table for investigator information
Principal Investigator: Sanford I Nidich, EdD Maharishi University of Management Research Institute
Principal Investigator: Thomas Rutledge, PhD San Diego VA Healthcare System

Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Sanford Nidich, Ed.D., Associate Director, Maharishi University of Management
ClinicalTrials.gov Identifier: NCT01865123     History of Changes
Other Study ID Numbers: PT110413
First Posted: May 30, 2013    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sanford Nidich, Ed.D., Maharishi University of Management:
post-traumatic stress disorder
transcendental meditation
cognitive behavioral therapy
prolonged exposure
Additional relevant MeSH terms:
Layout table for MeSH terms
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders