Transcendental Meditation vs Present Centered Therapy for PTSD

Recruiting at 4 trial locations

Overseen by Yuval Neria, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Research Foundation for Mental Hygiene, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests two treatments, Transcendental Meditation (TM) and Present Centered Therapy (PCT), for veterans and first responders with PTSD. TM uses meditation to calm the nervous system, while PCT focuses on current issues and coping strategies. Early research shows that Transcendental Meditation (TM) can help with PTSD. The goal is to find helpful treatments for PTSD in this group.

Research Team

Yuval Neria, PhD

Principal Investigator

NYSPI and Columbia University

Eligibility Criteria

This trial is for right-handed veterans and first responders aged 18-80 with PTSD, who can consent and are English literate. They must have a CAPS-5 score ≥ 25 and symptoms for at least 3 months. Exclusions include severe substance use disorders (except nicotine), unstable medical conditions, certain metal implants, claustrophobia in MRI scanners, recent psychiatric hospitalization or medication changes, pregnancy/breastfeeding women, current psychotherapy or meditation therapy users.

Inclusion Criteria

Prior or current military service OR prior or current work as a first responder (law enforcement, firefighters, and EMS)

Able to give consent, English literate

I have been diagnosed with PTSD and have had symptoms for at least 3 months.

Exclusion Criteria

Active suicidal or homicidal ideation or suicide attempt within two years of study enrollment

I haven't changed or started any mental health medications in the last 3 months.

Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body (for MRI)

Treatment Details

Interventions

• Present Centered Therapy (PCT) (Behavioural Intervention)
• Transcendental Meditation (TM) (Behavioural Intervention)

Trial Overview The study compares Transcendental Meditation (TM) with Present Centered Therapy (PCT) in treating PTSD. Participants will be randomly assigned to one of the treatments and assessed five times over six months via videoconferencing. The New York State Psychiatric Institute/Columbia protocol includes pre-and post-treatment MRIs to study brain changes.

Participant Groups

Group I: Present Centered Therapy (PCT): Active Control 1 Intervention

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.

Group II: Transcendental Meditation (TM): Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Research Foundation for Mental Hygiene, Inc.

Lead Sponsor

Trials

68

Recruited

21,100+

Dr. Jeffrey Borenstein

Research Foundation for Mental Hygiene, Inc.

Chief Executive Officer since 2012

MD from New York University, undergraduate degree from Harvard University

Dr. John McDaniel

Research Foundation for Mental Hygiene, Inc.

Chief Medical Officer since 2018

MD from Harvard Medical School

Mount Sinai Hospital, New York

Collaborator

Trials

37

Recruited

892,000+

David Lynch Foundation

Collaborator

Trials

4

Recruited

940+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Dr. Samir A.

University of Southern California

Chief Executive Officer since 2024

PhD in Molecular Biology from the University of Southern California

Dr. Chung

University of Southern California

Chief Medical Officer since 2016

MD from UC San Diego

Brown University

Collaborator

Trials

480

Recruited

724,000+

Mukesh Jain

Brown University

Chief Medical Officer since 2022

MD from Harvard Medical School

Christina H. Paxson

Brown University

Chief Executive Officer since 2012

PhD in Economics from Columbia University

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

New York State Psychiatric Institute

Collaborator

Trials

481

Recruited

154,000+

Dr. Elizabeth B. Ford

New York State Psychiatric Institute

Chief Medical Officer since 2023

MD

Dr. Joshua A. Gordon

New York State Psychiatric Institute

Chief Executive Officer

MD, PhD in Neuroscience

Northwell Health

Collaborator

Trials

481

Recruited

470,000+

Michael Dowling

Northwell Health

Chief Executive Officer since 2002

Bachelor's and Master's degrees from University College Cork, Ireland

Dr. David Battinelli

Northwell Health

Chief Medical Officer since 2022

MD from Georgetown University School of Medicine

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University