Clinical trial NCT04856033: Transcendental Meditation and PTSD
Official title: A Phase 3 Clinical Trial on Transcendental Meditation and Posttraumatic Stress Disorder, Suicide, and Substance Use in Veterans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ptsd
Depressive Symptoms
Suicidal Ideation
Alcohol Use, Unspecified
Keywords: Ptsd
Veterans
Meditation
Suicidal ideation
Randomized Controlled Trial
Lead sponsor: David Lynch Foundation
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 group RCT
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PTSD diagnosis and symptoms
timeFrame: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
measure: Alcohol use
timeFrame: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
measure: Suicidal ideation
timeFrame: Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: VA San Diego
name: Thomas Rutledge, PhD
role: PRINCIPAL_INVESTIGATOR
References: