Transcendental Meditation and PTSD

Ptsd Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04856033
• Other study ID #: DLF2021
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 2021
• Est. completion date: December 2023

Study information

• Verified date: April 2021
• Source: David Lynch Foundation
• Contact: Thomas Rutledge, PhD
• Phone: 8585528585
• Email: thomas.rutledge[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use, Unspecified
• Depression
• Depressive Symptoms
• Ptsd
• Suicidal Ideation

Intervention

Behavioral:
• TM
Transcendental Meditation instruction, 12-sessions over 3-4 months with monthly follow-up
• PCT
Present Centered Therapy, 12-sessions over 3-4 months with monthly follow-up

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
David Lynch Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD diagnosis and symptoms	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	Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Secondary	Depressive symptoms	Patient Health Questionnaire-9 (PHQ-9) changes, range=0-27, higher scores=higher depressive symptoms	Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Secondary	Alcohol use	Timeline Followback changes	Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Secondary	Suicidal ideation	Columbia-Suicide Severity Rating Scale (C-SSRS), range 0-25 with higher scores=greater suicidal ideation intensity	Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention