Transcendental Meditation and PTSD

A Phase 3 Clinical Trial on Transcendental Meditation and Posttraumatic Stress Disorder, Suicide, and Substance Use in Veterans

Sponsors

Lead Sponsor: David Lynch Foundation

Source David Lynch Foundation
Brief Summary

This paper describes the rationale and design of a Phase 3 RCT comparing Transcendental Meditation to Present Centered Therapy for posttraumatic stress disorder (PTSD), suicidal ideation, alcohol use, and depressive symptoms in Veterans. In this multisite trial, 450 Veterans meeting Diagnostic and Statistical Manual-5 (DSM-5) criteria for PTSD will be recruited from nine VA and academic medical center sites across the U.S. Study outcomes include changes in PTSD diagnosis and symptom severity (primary), suicidal ideation, alcohol use, and depressive symptoms. Participation includes baseline testing and post-treatment assessments at 12, 24, and 36-weeks. During each assessment visit, Veterans will complete diagnostic interviews, including the Clinician-Administered PTSD Scale for DSM-5 and the Alcohol Timeline Followback, as well as validated self-report measures. Cost-effectiveness of the treatments will be measured using intervention and healthcare costs, the proportion with PTSD diagnosis removed, and Quality-Adjusted Life Years. Finally, single-site substudies will examine pre-to-post-treatment changes in PTSD biomarkers and on magnetic resonance imaging (MRI).

Detailed Description

Background: The evidence supporting the Transcendental Meditation (TM) technique as a treatment for posttraumatic stress disorder (PTSD) has advanced considerably in the past decade. With a recent randomized controlled trial (RCT) suggesting statistical superiority to active control treatments for PTSD (e.g., Present Centered Therapy [PCT]) and noninferiority to first-line PTSD psychotherapies, additional research evaluating the benefits and cost-effectiveness of TM for PTSD among Veterans is needed. Methods and design: This paper describes the rationale and design of a Phase 3 RCT comparing TM to PCT for PTSD in Veterans. In this multisite trial, 450 Veterans meeting DSM-5 criteria for PTSD will be recruited from nine VA and academic medical center sites across the U.S. Study outcomes include changes in PTSD diagnosis and symptom severity (primary), suicidal ideation, alcohol use, and depressive symptoms. Participation includes baseline testing and post-treatment assessments at 12, 24, and 36-weeks. During each assessment visit, Veterans will complete diagnostic interviews, including the Clinician-Administered PTSD Scale for DSM-5 and the Alcohol Timeline Followback, as well as validated self-report measures. Cost-effectiveness of the treatments will be measured using intervention and healthcare costs, the proportion with PTSD diagnosis removed, and Quality-Adjusted Life Years. Finally, single-site substudies will examine pre-to-post-treatment changes in PTSD biomarkers and on magnetic resonance imaging (MRI). Discussion: Despite progress in PTSD treatments, new evidence-based treatments are still needed for Veterans who drop-out of or respond poorly to existing trauma-focused psychotherapies and that may assist Veterans with common PTSD-comorbidities such as depression, suicidal ideation, and substance use. This multisite trial seeks to advance the science and potential application of TM as a treatment for PTSD in Veterans.

Overall Status Not yet recruiting
Start Date 2021-10-01
Completion Date 2023-12-01
Primary Completion Date 2023-12-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
PTSD diagnosis and symptoms Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Secondary Outcome
Measure Time Frame
Depressive symptoms Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Alcohol use Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Suicidal ideation Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Enrollment 450
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: TM

Description: Transcendental Meditation instruction, 12-sessions over 3-4 months with monthly follow-up

Arm Group Label: TM

Intervention Type: Behavioral

Intervention Name: PCT

Description: Present Centered Therapy, 12-sessions over 3-4 months with monthly follow-up

Arm Group Label: PCT

Eligibility

Criteria:

Inclusion Criteria: 1. Current diagnosis of PTSD from medical record or CAPS-5 interview 2. A symptom severity score≥33 on the CAPS-5 indicating clinically significant PTSD symptoms 3. Three or more months since trauma 4. Agreement to not receive other psychotherapy or meditation for PTSD during the active treatment or follow-up period. Psychotherapy for other problems will be allowed. 5. If being treated with psychoactive medications, a stable regimen (no change in drugs or dose) for at least 2 months before enrollment 6. Age: 18 years or older 7. Language: English literate Exclusion Criteria: 1. Prior training with TM or treatment with PCT in the past year 2. Currently untreated psychotic symptoms or mania symptoms from chart review or self-report 3. Moderate or greater cognitive impairment indicated by chart diagnosis or observable cognitive difficulties 4. Acute severe symptoms (such as imminent suicidal risk) that will likely require active treatment intervention (such as medication changes) within the course of the study 5. Psychiatric hospitalization in the previous six months

Gender:

All

Minimum Age:

18 Years

Maximum Age:

100 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Thomas Rutledge, PhD Principal Investigator VA San Diego
Overall Contact

Last Name: Thomas Rutledge, PhD

Phone: 8585528585

Email: [email protected]

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: TM

Type: Experimental

Description: Transcendental Mediation

Label: PCT

Type: Active Comparator

Description: Present Centered Therapy

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 2 group RCT

Primary Purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

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