Transcendental Meditation in Veterans and First Responders With PTSD

Summary

The present study is part of a Phase 3 multi-site clinical trial that will recruit veterans and first responders diagnosed with PTSD, where they will be randomized to receive either Transcendental Meditation (TM) or Present Centered Therapy (PCT). Five assessments will be conducted, at: 1) baseline, 2) midpoint, 3) posttreatment, 4) three months posttreatment and 5) six months posttreatment. All assessments will be completed using remote HIPAA-compliant videoconferencing. The study protocol at NYSPI/Columbia will also include Magnetic Resonance Imaging (MRI) before and after treatment to elucidate neural predictors and mechanisms of these two treatment approaches.

Enrollment will include veterans and first responders with PTSD. Both TM and PCT will be provided by trained staff receiving weekly supervision. This trial is funded by the David Lynch Foundation and will recruit approximately 360 veterans and first responders over a three-year period.

Conditions

• PTSD

Interventions

BEHAVIORAL

Transcendental Meditation (TM)

During the first week, each participant randomized to undergo TM will meet with a TM instructor on four consecutive days for 60 minutes, for an introductory training. Next, participants will meet for twelve 60-minute sessions over the course of three months and then once monthly for booster sessions for 6 months. All sessions will be recorded and reviewed for adherence to the TM protocol.

BEHAVIORAL

Present Centered Therapy (PCT)

PCT treatments will be delivered by trained clinicians at master's or doctoral-level. Study therapists will be supervised by a a licensed psychologist. Participants assigned to this treatment will meet with a PCT therapist once a week for twelve 60-minute sessions over the course of 3 months and then monthly for months four through nine. Sessions will focus on current life problems as manifestations of PTSD. All sessions will be recorded and reviewed for adherence to the treatment protocol.

Sponsors & Collaborators

• Columbia University

  collaborator OTHER

• Northwell Health

  collaborator OTHER

• Brown University

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• VA Palo Alto Health Care System

  collaborator FED

• New York State Psychiatric Institute

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Research Foundation for Mental Hygiene, Inc.

  lead OTHER

Principal Investigators

• Yuval Neria, PhD · NYSPI and Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-12

Primary Completion

2024-10-30

Completion

2024-10-30

Countries

• United States

Study Locations