- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04856033
Transcendental Meditation and PTSD
A Phase 3 Clinical Trial on Transcendental Meditation and Posttraumatic Stress Disorder, Suicide, and Substance Use in Veterans
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Thomas Rutledge, PhD
- Phone Number: 8585528585
- Email: thomas.rutledge@va.gov
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Current diagnosis of PTSD from medical record or CAPS-5 interview
- A symptom severity score≥33 on the CAPS-5 indicating clinically significant PTSD symptoms
- Three or more months since trauma
- 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.
- If being treated with psychoactive medications, a stable regimen (no change in drugs or dose) for at least 2 months before enrollment
- Age: 18 years or older
- Language: English literate
Exclusion Criteria:
- Prior training with TM or treatment with PCT in the past year
- Currently untreated psychotic symptoms or mania symptoms from chart review or self-report
- Moderate or greater cognitive impairment indicated by chart diagnosis or observable cognitive difficulties
- 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
- Psychiatric hospitalization in the previous six months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TM
Transcendental Mediation
|
Transcendental Meditation instruction, 12-sessions over 3-4 months with monthly follow-up
|
Active Comparator: PCT
Present Centered Therapy
|
Present Centered Therapy, 12-sessions over 3-4 months with monthly follow-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD diagnosis and symptoms
Time Frame: 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
|
Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive symptoms
Time Frame: 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
|
Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
|
Alcohol use
Time Frame: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
|
Timeline Followback changes
|
Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
|
Suicidal ideation
Time Frame: 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
|
Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Rutledge, PhD, VA San Diego
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLF2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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