Clinical Trials Logo

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.


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

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03962504 - Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial N/A
Completed NCT01995123 - Behavioral Activation for Smoking Cessation in PTSD N/A
Not yet recruiting NCT06278922 - Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma N/A
Completed NCT04597450 - Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD) Phase 1
Completed NCT03593772 - Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD N/A
Completed NCT03429166 - Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas N/A
Recruiting NCT04317820 - Deep Brain Reorienting in Post-traumatic Stress Disorder N/A
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Completed NCT03504722 - Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD N/A
Completed NCT04305353 - Intensive Care Unit (ICU) Diary Project N/A
Completed NCT03113890 - McLean and Genomind Prospective Study N/A
Withdrawn NCT05173831 - Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans Phase 2
Withdrawn NCT03924297 - Chilipad for Sleep and Symptoms of PTSD N/A
Not yet recruiting NCT04056767 - Changes in Digital Phenotype During PE Therapy
Withdrawn NCT03216356 - Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD Phase 2/Phase 3
Completed NCT03343028 - Biomarker Establishment for Superior Treatment of PTSD
Completed NCT03158558 - Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD N/A
Completed NCT02370173 - A Non-Pharmacological Method for Enhancing Sleep in PTSD N/A
Withdrawn NCT01957371 - Mindful Yoga Therapy for Veterans With PTSD and Pain N/A
Completed NCT01911585 - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure N/A