Transcendental Meditation in Veterans and First Responders With PTSD

NCT05645042 | Terminated DMC

• 1 other identifier: 8172
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptoms over time

  Change in symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5: ranging from 0-80) from pre- to post-treatment. Lower scores indicate lower symptom levels of PTSD.

  Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake

Secondary Outcomes (1)

• Change in depressive symptoms over time

  Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake

Study Arms (2)

Transcendental Meditation (TM):

ACTIVE COMPARATOR

TM treatment for PTSD is designed to reduce stress, facilitate deep rest, and increase well-being. It was originally conceptualized as an effortless technique to enable physical relaxation. The treatment will be delivered by experienced, certified TM instructors receiving weekly supervision.

Behavioral: Transcendental Meditation (TM)

Present Centered Therapy (PCT):

ACTIVE COMPARATOR

PCT is a focused time-limited treatment for PTSD that focuses on increasing adaptive responses to current life stressors and difficulties that are directly or indirectly related to trauma or PTSD symptoms. PCT was originally designed as a treatment comparator in trials evaluating the effectiveness of trauma-focused cognitive-behavioral therapies such as PE and CPT. Several clinical trials have indicated that PCT may be an effective treatment option for PTSD and that patients may drop out of PCT at lower rates relative to trauma focused forms of CBT.

Behavioral: Present Centered Therapy (PCT)

Interventions

Transcendental Meditation (TM) BEHAVIORAL

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.

Transcendental Meditation (TM):

Present Centered Therapy (PCT) BEHAVIORAL

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.

Present Centered Therapy (PCT):

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior or current military service OR prior or current work as a first responder (law enforcement, firefighters, and EMS)
• Active and primary diagnosis of PTSD with symptom duration ≥ 3 months
• CAPS-5 score ≥ 25 at intake assessment
• Age 18 - 80
• Able to give consent, English literate

You may not qualify if:

• Previous or current treatment with Transcendental Meditation, Present Centered Therapy, or any current psychotherapy.
• Current severe alcohol/cannabis use disorder or any other current substance use disorder except nicotine (i.e., nicotine use disorder and mild-moderate alcohol/cannabis use disorder are allowed)
• History of or present psychiatric diagnosis of psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder
• Current diagnosis of bipolar disorder
• Active suicidal or homicidal ideation or suicide attempt within two years of study enrollment
• Psychiatric hospitalization in the past six months
• Intent to change or begin new psychotherapy or other meditation therapy during 3-month study treatment
• Intent to enroll in another research study testing an experimental intervention during three-month period of study intervention
• Recent psychotropic medication dosage change or initiation within the three months prior to study enrollment
• Intent to change dosage of or initiate new psychotropic medication during the three-month period of study intervention
• Medical illness that could interfere with assessment of diagnosis, such as organic brain impairment or unstable thyroid disease
• Current unstable medical illness
• Prior or current military service OR prior or current work as a first responder (law enforcement, firefighters, and/or EMS)
• Active and primary diagnosis of PTSD with symptom duration ≥ 3 months
• CAPS-5 score ≥ 25 at intake assessment

Sponsors & Collaborators

• Research Foundation for Mental Hygiene, Inc.: lead
• Columbia University: collaborator
• Northwell Health: collaborator
• Brown University: collaborator
• University of California, San Diego: collaborator
• University of Southern California: collaborator
• VA Palo Alto Health Care System: collaborator
• New York State Psychiatric Institute: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (5)

University of California San Diego

La Jolla, California, 92093, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (2)

• Nidich S, Mills PJ, Rainforth M, Heppner P, Schneider RH, Rosenthal NE, Salerno J, Gaylord-King C, Rutledge T. Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: a randomised controlled trial. Lancet Psychiatry. 2018 Dec;5(12):975-986. doi: 10.1016/S2215-0366(18)30384-5. Epub 2018 Nov 15.

  PMID: 30449712 BACKGROUND

• Belsher BE, Beech E, Evatt D, Smolenski DJ, Shea MT, Otto JL, Rosen CS, Schnurr PP. Present-centered therapy (PCT) for post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2019 Nov 18;2019(11):CD012898. doi: 10.1002/14651858.CD012898.pub2.

  PMID: 31742672 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Meditation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Yuval Neria, PhD

  NYSPI and Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Psychology

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 9, 2022
• Study Start: December 12, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

US (5)