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Recruiting
NCT05645042
Transcendental Meditation in Veterans and First Responders With PTSD
Conditions: PTSD
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 360
Sponsor: Research Foundation for Mental Hygiene, Inc.
Location: United States
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.
Eligibility Criteria
General Inclusion Criteria:Prior or current military service OR prior or current work as a first responder (law enforcement, firefighters, and EMS)Active and primary diagnosis of PTSD with symptom duration ≥ 3 monthsCAPS-5 score ≥ 25 at intake assessmentAge 18 - 80Able to give consent, English literateGeneral Exclusion Criteria:Previous or current treatment with Transcendental Meditation, Present Centered Therapy, or any current psychotherapy.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)History of or present psychiatric diagnosis of psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorderCurrent diagnosis of bipolar disorderActive suicidal or homicidal ideation or suicide attempt within two years of study enrollmentPsychiatric hospitalization in the past six monthsIntent to change or begin new psychotherapy or other meditation therapy during 3-month study treatmentIntent to enroll in another research study testing an experimental intervention during three-month period of study interventionRecent psychotropic medication dosage change or initiation within the three months prior to study enrollmentIntent to change dosage of or initiate new psychotropic medication during the three-month period of study interventionMedical illness that could interfere with assessment of diagnosis, such as organic brain impairment or unstable thyroid diseaseCurrent unstable medical illnessMRI Inclusion Criteria:Prior or current military service OR prior or current work as a first responder (law enforcement, firefighters, and/or EMS)Active and primary diagnosis of PTSD with symptom duration ≥ 3 monthsCAPS-5 score ≥ 25 at intake assessmentAge 18 - 80Able to give consent, English literateRight handedMRI Exclusion Criteria:Previous or current treatment with Transcendental Meditation, Present Centered Therapy, or any current psychotherapy.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)History of or current psychiatric diagnosis of psychotic episode, psychotic disorder, schizophrenia, schizoaffective disorderCurrent diagnosis of bipolar disorderActive suicidal or homicidal ideation or suicide attempt within two years of study enrollmentPsychiatric hospitalization in the past six monthsIntent to change or begin new psychotherapy or other meditation therapy during 3-month study interventionIntent to enroll in another research study testing an experimental intervention during three-month period of study interventionRecent psychotropic medication dosage change or initiation within the three months prior to study enrollmentIntent to change dosage of or initiate new psychotropic medication during the three-month period of study interventionParamagnetic metallic implants or devices contraindicating magnetic resonance imaging or any other non-removable paramagnetic metal in the body.Medical illness that could interfere with assessment of diagnosis, such as organic brain impairment or unstable thyroid diseaseCurrent unstable medical illnessAny condition that would exclude clinical MRI exam (e.g.
pacemaker, paramagnetic metallic prosthesis, surgical clips, shrapnel, necessity for constant medicinal patch, some tattoos)Significant claustrophobia that would preclude ability to remain calm within the MRI scannerFemales who are pregnant or breastfeeding, or plan to become pregnant during the period of the study.
Source: ClinicalTrials.gov (NCT05645042). StuddyBuddy aggregates publicly available trial information.