Status:

UNKNOWN

Transcendental Meditation and PTSD

Lead Sponsor:

David Lynch Foundation

Conditions:

Ptsd

Depressive Symptoms

Eligibility:

All Genders

18-100 years

Phase:

PHASE3

Brief Summary

This paper describes the rationale and design of a Phase 3 RCT comparing Transcendental Meditation to Present Centered Therapy for posttraumatic stress disorder (PTSD), suicidal ideation, alcohol use,...

Detailed Description

Background: The evidence supporting the Transcendental Meditation (TM) technique as a treatment for posttraumatic stress disorder (PTSD) has advanced considerably in the past decade. With a recent ran...

Eligibility Criteria

Inclusion

  • Current diagnosis of PTSD from medical record or CAPS-5 interview
  • A symptom severity score≥33 on the CAPS-5 indicating clinically significant PTSD symptoms
  • Three or more months since trauma
  • Agreement to not receive other psychotherapy or meditation for PTSD during the active treatment or follow-up period. Psychotherapy for other problems will be allowed.
  • If being treated with psychoactive medications, a stable regimen (no change in drugs or dose) for at least 2 months before enrollment
  • Age: 18 years or older
  • Language: English literate

Exclusion

  • Prior training with TM or treatment with PCT in the past year
  • Currently untreated psychotic symptoms or mania symptoms from chart review or self-report
  • Moderate or greater cognitive impairment indicated by chart diagnosis or observable cognitive difficulties
  • Acute severe symptoms (such as imminent suicidal risk) that will likely require active treatment intervention (such as medication changes) within the course of the study
  • Psychiatric hospitalization in the previous six months

Key Trial Info

Start Date :

October 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2023

Estimated Enrollment :

450 Patients enrolled

Trial Details

Trial ID

NCT04856033

Start Date

October 1 2021

End Date

December 1 2023

Last Update

April 22 2021

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