Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT04856033 |
Other study ID # |
DLF2021 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
Phase 3
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.