NCT01865123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

3.2 years

First QC Date

May 24, 2013

Last Update Submit

November 21, 2018

Conditions

Post-traumatic Stress Disorder

Keywords

post-traumatic stress disordertranscendental meditationcognitive behavioral therapyprolonged exposure

Outcome Measures

Primary Outcomes (1)

  • Clinically Administered PTSD Scale (CAPS)

    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.

    3 months

Secondary Outcomes (1)

  • Self-Report Symptoms of PTSD

    3 months

Other Outcomes (3)

  • Behavioral Measures

    3 months

  • Biomarkers of Stress

    3 months

  • Treatment Adherence

    3 months

Study Arms (3)

Transcendental Meditation

EXPERIMENTAL

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

Prolonged Exposure

ACTIVE COMPARATOR

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

Educational Control

PLACEBO COMPARATOR

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

Interventions

Transcendental MeditationBEHAVIORAL

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.

Also known as: meditation, mantra meditation, stress management
Transcendental Meditation
Prolonged ExposureBEHAVIORAL

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.

Also known as: Cognitive Behavioral Therapy
Prolonged Exposure
Educational controlBEHAVIORAL

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.

Also known as: Health Education
Educational Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego VA Healthcare System

La Jolla, California, United States

Location

Related Publications (2)

  • 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.

    PMID: 25066921BACKGROUND

  • 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.

    PMID: 30449712RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

MeditationCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sanford I Nidich, EdD

    Maharishi University of Management Research Institute

    PRINCIPAL INVESTIGATOR

  • Thomas Rutledge, PhD

    San Diego VA Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director

Study Record Dates

First Submitted

May 24, 2013

First Posted

May 30, 2013

Study Start

June 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 26, 2018

Record last verified: 2018-11

Locations

US(1)