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Transcendental Meditation in Veterans and First Responders With PTSD

A legfontosabb adatok

Ki végzi
Research Foundation for Mental Hygiene, Inc.
Hol
Great Neck, La Jolla, Los Angeles, New York és Palo Alto (Egyesült Államok)Mind a 5 helyszín megnézése
Azonosító
Állapot
Leállítva
Résztvevők
55 fő vett részt
Kezdés
2022. dec. 12.
Befejezés
2024. okt. 30.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Transcendental Meditation (TM)
  • Present Centered Therapy (PCT)
A regiszteradat frissítve
2025. április 9.
Miért állt le
The sponsor made a decision to terminate the study.

Ki vehet részt

Életkor
18 év – 80 év
Nem
Nők és férfiak
Egészséges önkéntesek
Részt vehetnek

A regiszter feltételei, szó szerint

Mind a 40 feltétel megnézéseKevesebb

Egyéb feltételek

  • 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 months
  • CAPS-5 score ≥ 25 at intake assessment
  • Age 18 - 80
  • Able to give consent, English literate; General 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 disorder
  • Current diagnosis of bipolar disorder
  • Active suicidal or homicidal ideation or suicide attempt within two years of study enrollment
  • Psychiatric hospitalization in the past six months
  • Intent to change or begin new psychotherapy or other meditation therapy during 3-month study treatment
  • Intent to enroll in another research study testing an experimental intervention during three-month period of study intervention
  • Recent psychotropic medication dosage change or initiation within the three months prior to study enrollment
  • Intent to change dosage of or initiate new psychotropic medication during the three-month period of study intervention
  • Medical illness that could interfere with assessment of diagnosis, such as organic brain impairment or unstable thyroid disease
  • Current unstable medical illness; MRI 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 months
  • CAPS-5 score ≥ 25 at intake assessment
  • Age 18 - 80
  • Able to give consent, English literate
  • Right handed; MRI 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 disorder
  • Current diagnosis of bipolar disorder
  • Active suicidal or homicidal ideation or suicide attempt within two years of study enrollment
  • Psychiatric hospitalization in the past six months
  • Intent to change or begin new psychotherapy or other meditation therapy during 3-month study intervention
  • Intent to enroll in another research study testing an experimental intervention during three-month period of study intervention
  • Recent psychotropic medication dosage change or initiation within the three months prior to study enrollment
  • Intent to change dosage of or initiate new psychotropic medication during the three-month period of study intervention
  • Paramagnetic 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 disease
  • Current unstable medical illness
  • Any 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 scanner
  • Females who are pregnant or breastfeeding, or plan to become pregnant during the period of the study

Helyszínek itt: Egyesült Államok

  • Northwell HealthGreat Neck, Egyesült Államok
  • University of California San DiegoLa Jolla, Egyesült Államok
  • University of Southern CaliforniaLos Angeles, Egyesült Államok
  • New York State Psychiatric InstituteNew York, Egyesült Államok
  • Stanford UniversityPalo Alto, Egyesült Államok

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • Transcendental Meditation (TM):Már használt kezelés, összehasonlításként

    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.

  • Present Centered Therapy (PCT):Már használt kezelés, összehasonlításként

    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.

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
A regiszteradat frissítve
2025. április 9.