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PTSDNCT05645042

Transcendental Meditation in Veterans and First Responders With PTSD

A study testing Transcendental Meditation (TM) and Present Centered Therapy (PCT) in people with PTSD, run by Research Foundation for Mental Hygiene, Inc. at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
PTSD
What is being tested?
Transcendental Meditation (TM) and Present Centered Therapy (PCT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
5 sitesUnited States
Study dates
12 Dec 2022to 30 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites
  • Northwell Health

    Great Neck, New York, 11021

  • University of California San Diego

    La Jolla, California, 92093

  • University of Southern California

    Los Angeles, California, 90033

  • New York State Psychiatric Institute

    New York, New York, 10032

  • Stanford University

    Palo Alto, California, 94305

Other trials in United States

About this study

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.

Read the 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.

Conditions
PTSD
Being tested
Transcendental Meditation (TM), Present Centered Therapy (PCT)
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcendental Meditation (TM)Behavioural

    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)Behavioural

    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.

Study groups in NCT05645042
Study groupRoleWhat they receive
Transcendental Meditation (TM):Active comparatorTM 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.
Receives: Behavioral: Transcendental Meditation (TM)
Present Centered Therapy (PCT):Active comparatorPCT 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.
Receives: Behavioral: Present Centered Therapy (PCT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2022
  2. Study start12 Dec 2022
  3. Primary completion30 Oct 2024
  4. Study completion30 Oct 2024

Why it stopped: The sponsor made a decision to terminate the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05645042
Sponsor's protocol ID
8172
Status last verified
Apr 2025
First submitted
1 Dec 2022
Last updated
9 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30449712
  • 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.

    PubMed 31742672

Questions about this trial

What is this clinical trial studying?

A study testing Transcendental Meditation (TM) and Present Centered Therapy (PCT) in people with PTSD, run by Research Foundation for Mental Hygiene, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The sponsor made a decision to terminate the study.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PTSD symptoms over time (time frame: Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05645042, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.

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