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

NCT01865123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-11-26

No results posted yet for this study

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.

Conditions

  • Post-traumatic Stress Disorder

Interventions

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.

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.

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.

Sponsors & Collaborators

  • San Diego Veterans Healthcare System

    collaborator FED
  • Maharishi University of Management Research Institute

    collaborator OTHER
  • University of California, San Diego

    collaborator OTHER
  • United States Department of Defense

    lead FED

Principal Investigators

  • Sanford I Nidich, EdD · Maharishi University of Management Research Institute

  • Thomas Rutledge, PhD · San Diego VA Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01865123 on ClinicalTrials.gov