Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01865123
Previous Study | Return to List | Next Study

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

Tracking Information
First Submitted Date  ICMJE May 24, 2013
First Posted Date  ICMJE May 30, 2013
Last Update Posted Date November 26, 2018
Study Start Date  ICMJE June 2013
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 24, 2013)
  • 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
  • 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).
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans
Official Title  ICMJE A Randomized Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post-traumatic Stress Disorder
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Transcendental Meditation
  • 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.
    Intervention: Behavioral: Prolonged Exposure
  • 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.
    Intervention: Behavioral: Educational control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2016)
200
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2013)
210
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01865123
Other Study ID Numbers  ICMJE PT110413
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sanford Nidich, Ed.D., Maharishi University of Management
Study Sponsor  ICMJE United States Department of Defense
Collaborators  ICMJE
  • San Diego Veterans Healthcare System
  • Maharishi University of Management Research Institute
  • University of California, San Diego
Investigators  ICMJE
Principal Investigator: Sanford I Nidich, EdD Maharishi University of Management Research Institute
Principal Investigator: Thomas Rutledge, PhD San Diego VA Healthcare System
PRS Account United States Department of Defense
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP