An interventional study of Transcendental Meditation (TM) and Present Centered Therapy (PCT) in PTSD, sponsored by Research Foundation for Mental Hygiene, Inc.. Terminated at 5 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Research Foundation for Mental Hygiene, Inc. · Not applicable, Interventional, and Treatment
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.
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.
Research Foundation for Mental Hygiene, Inc. is the lead sponsor of 35 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
General Inclusion Criteria:
General Exclusion Criteria:
MRI Inclusion Criteria:
MRI Exclusion Criteria:
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)
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)
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.
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.
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.
Time frame: Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake
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.
Time frame: Baseline, At 6 weeks, Post-treatment: approximately 3 months and 6 months from intake
This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Research Foundation for Mental Hygiene, Inc.