NCT04856033

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

April 16, 2021

Last Update Submit

April 20, 2021

Conditions

PtsdDepressive SymptomsSuicidal IdeationAlcohol Use, Unspecified

Keywords

PtsdVeteransMeditationSuicidal ideationRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Depressive symptoms

    Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention

  • Alcohol use

    Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention

  • Suicidal ideation

    Baseline, immediately after the intervention, 12-weeks after the intervention, 24-weeks after the intervention

Study Arms (2)

TM

EXPERIMENTAL

Transcendental Mediation

Behavioral: TM

PCT

ACTIVE COMPARATOR

Present Centered Therapy

Behavioral: PCT

Interventions

TMBEHAVIORAL

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

TM
PCTBEHAVIORAL

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

PCT

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionSuicidal IdeationAlcohol Drinking

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehaviorSuicideSelf-Injurious BehaviorDrinking Behavior

Study Officials

  • Thomas Rutledge, PhD

    VA San Diego

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Rutledge, PhD

CONTACT

8585528585thomas.rutledge@va.gov

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 group RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 22, 2021

Study Start

October 1, 2021

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 22, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share