Clinical trial NCT05645042: Transcendental Meditation in Veterans and First Responders With PTSD
Official title: Transcendental Meditation in Veterans and First Responders With PTSD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: PTSD
Lead sponsor: Research Foundation for Mental Hygiene, Inc.
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Northwell Health
name: Brown University
name: University of California, San Diego
name: University of Southern California
name: VA Palo Alto Health Care System
name: New York State Psychiatric Institute
name: Icahn School of Medicine at Mount Sinai
First posted: 2022-12-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in PTSD symptoms over time
timeFrame: Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake
Secondary outcomes:
measure: Change in depressive symptoms over time
timeFrame: Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: NYSPI and Columbia University
name: Yuval Neria, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.