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Transcendental Meditation and PTSD

NCT04856033 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2021-04-22

No results posted yet for this study

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).

Conditions

Interventions

BEHAVIORAL

TM

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

BEHAVIORAL

PCT

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

Sponsors & Collaborators

  • David Lynch Foundation

    lead OTHER

Principal Investigators

  • Thomas Rutledge, PhD · VA San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2023-12-31
Completion
2023-12-31

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Entities

Diseases

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 NCT04856033 on ClinicalTrials.gov