Transcendental Meditation in Veterans and First Responders With PTSD

PTSD Clinical Trial

Official title:

Transcendental Meditation in Veterans and First Responders With PTSD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645042
• Other study ID #: 8172
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Research Foundation for Mental Hygiene, Inc.
• Contact: Yuval Neria, PhD
• Phone: 646-774-8092
• Email: yuval.neria[@]nyspi.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PTSD is among the most common and disabling problems for veterans and first responders. Although PTSD from combat-related events is widely known, veterans and first-responders also face traumatic experiences from other events including sexual trauma, accidents, and injuries. Recent findings, for example, indicated that nearly a quarter of female Veterans experienced sexual assault when in the military.

At present, the non-medication therapies for PTSD with the strongest scientific support include Prolonged Exposure (PE), Cognitive Processing Therapy (CPT), and Eye Movement Desensitization and Reprocessing (EMDR). While many patients with PTSD benefit from these therapies, research indicates that these psychotherapies appear to be less effective for veterans than for civilians with PTSD, and many veterans may remained symptomatic in the long run. Based on this evidence, there is a clear need for new PTSD treatments that are effective for and amenable to the unique circumstances of veterans and first-responders.

Transcendental Meditation (TM) is a promising intervention. A phase 2 clinical trial, funded by the Department of Defense and conducted at the San Diego VA, showed that TM significantly reduces both PTSD symptom severity and depression in a veteran population, with post-hoc analysis indicating reduced suicidal ideation. Relative to conventional PTSD treatments that aim to improve symptoms through mechanisms such as habituation to anxiety-provoking stimuli and desensitization to trauma-related memories, TM improves symptoms by aiming to calm down the nervous system.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

General Inclusion Criteria:

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

2. Active and primary diagnosis of PTSD with symptom duration = 3 months

3. CAPS-5 score = 25 at intake assessment

4. Age 18 - 80

5. Able to give consent, English literate

General Exclusion Criteria:

1. Previous or current treatment with Transcendental Meditation, Present Centered Therapy, or any current psychotherapy.

2. 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)

3. History of or present psychiatric diagnosis of psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder

4. Current diagnosis of bipolar disorder

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

6. Psychiatric hospitalization in the past six months

7. Intent to change or begin new psychotherapy or other meditation therapy during 3-month study treatment

8. Intent to enroll in another research study testing an experimental intervention during three-month period of study intervention

9. Recent psychotropic medication dosage change or initiation within the three months prior to study enrollment

10. Intent to change dosage of or initiate new psychotropic medication during the three-month period of study intervention

11. Medical illness that could interfere with assessment of diagnosis, such as organic brain impairment or unstable thyroid disease

12. Current unstable medical illness

MRI Inclusion Criteria:

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

2. Active and primary diagnosis of PTSD with symptom duration = 3 months

3. CAPS-5 score = 25 at intake assessment

4. Age 18 - 80

5. Able to give consent, English literate

6. Right handed

MRI Exclusion Criteria:

1. Previous or current treatment with Transcendental Meditation, Present Centered Therapy, or any current psychotherapy.

2. 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)

3. History of or current psychiatric diagnosis of psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorder

4. Current diagnosis of bipolar disorder

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

6. Psychiatric hospitalization in the past six months

7. Intent to change or begin new psychotherapy or other meditation therapy during 3-month study intervention

8. Intent to enroll in another research study testing an experimental intervention during three-month period of study intervention

9. Recent psychotropic medication dosage change or initiation within the three months prior to study enrollment

10. Intent to change dosage of or initiate new psychotropic medication during the three-month period of study intervention

11. Paramagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body.

12. Medical illness that could interfere with assessment of diagnosis, such as organic brain impairment or unstable thyroid disease

13. Current unstable medical illness

14. Any condition that would exclude clinical MRI exam (e.g. pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos)

15. Significant claustrophobia that would preclude ability to remain calm within the MRI scanner

16. Females who are pregnant or breastfeeding, or plan to become pregnant during the period of the study.

Related Conditions & MeSH terms

• PTSD

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (9)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in depressive symptoms over time	Change in symptoms as measured by the Hamilton Depression Rating Scale (HDRS-24; range 0-76) from pre- to post-treatment. Lower scores indicate lower symptom levels of depression.	Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake