Transcendental Meditation and PTSD

• Sponsor: David Lynch Foundation (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04856033
• Collaborator: (none)
• Enrollment: 450
• Arms: 2
• Anticipated Duration (Months): 26

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Ptsd; Depressive Symptoms; Suicidal Ideation; Alcohol Use, Unspecified	Behavioral: TM; Behavioral: PCT	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 2 group RCT2 group RCT
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Clinical Trial on Transcendental Meditation and Posttraumatic Stress Disorder, Suicide, and Substance Use in Veterans
• Anticipated Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TM Transcendental Mediation	Behavioral: TM; Transcendental Meditation instruction, 12-sessions over 3-4 months with monthly follow-up
Active Comparator: PCT Present Centered Therapy	Behavioral: PCT; Present Centered Therapy, 12-sessions over 3-4 months with monthly follow-up

Outcome Measures

Primary Outcome Measures

1. PTSD diagnosis and symptoms [Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention]

   Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) changes in PTSD diagnosis and symptom severity. Scores range from 0-80 with higher scores=higher PTSD symptoms

Secondary Outcome Measures

1. Depressive symptoms [Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention]

   Patient Health Questionnaire-9 (PHQ-9) changes, range=0-27, higher scores=higher depressive symptoms

2. Alcohol use [Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention]

   Timeline Followback changes

3. Suicidal ideation [Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention]

   Columbia-Suicide Severity Rating Scale (C-SSRS), range 0-25 with higher scores=greater suicidal ideation intensity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• David Lynch Foundation

Investigators

• Principal Investigator: Thomas Rutledge, PhD, VA San Diego

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Lynch Foundation
• ClinicalTrials.gov Identifier: NCT04856033
• Other Study ID Numbers: DLF2021
• First Posted: Apr 22, 2021
• Last Update Posted: Apr 22, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by David Lynch Foundation: Ptsd; Veterans; Meditation; Suicidal ideation; Randomized Controlled Trial
• Additional relevant MeSH terms: Depression; Suicidal Ideation

Study Results

No Results Posted as of Apr 22, 2021