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Completed

NCT Number: NCT05058963

Virtual Mantram Program for Patients With PTSD and SUD

The purpose of this study is to evaluate a virtual Mantram repetition program for adults with PTSD and substance use disorders. The program involves repetition of a personalized Mantram, which is a word or short phrase with spiritual meaning that is frequently repeated throughout the day. The program also involves slowing down thoughts and have one-pointed attention that help with stress.

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Key information

Conditions

Post Traumatic Stress Disorder Chemically-Induced Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance Use Disorders Substance-Related Disorders Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

About this study

The purpose of this study is to evaluate a virtual Mantram repetition program for adults with PTSD and substance use disorders. The program involves repetition of a personalized Mantram, which is a word or short phrase with spiritual meaning that is frequently repeated throughout the day. The program also involves slowing down thoughts and have one-pointed attention that help with stress.

The study starts with an eligibility and baseline assessment, which involves completing a series of questionnaires. Following these assessments, enrolled participants will be placed into a Mantram repetition program group led by two facilitators. This group will consist of 5 to 8 participants who will meet virtually every week for ninety minutes over an 8-week period. During this time, participants will also be asked to complete weekly self-reported questionnaires on their own. Additionally, at weeks 4 and 8, the participants will complete assessments and questionnaires with a member of the study team. The program will end after week 8. At week 12, participants will be invited to participate in a focus group to complete additional assessments, as well as be asked open-ended questions assessing the impact of the program on PTSD symptoms, substance use, and substance use cravings.

In summary, the Mantram group program will take 8 weeks to complete and the assessments will take approximately 12 weeks to complete. Participants will receive compensation of up to $200 for their participation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • participants 18-years old or older
  • fluent in English
  • diagnosed with PTSD by a healthcare practitioner confirmed with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5 past month version)
  • diagnosed with past-year substance use disorder other than tobacco or caffeine by a healthcare practitioner confirmed by Structured clinical interview for DSM-5 (SCID-5)
  • agreed not to participate in other therapies during the program (mindfulness, yoga, biofeedback, self-hypnosis or tai chi)
  • willing to commit to attend all sessions

Exclusion criteria

  • diagnosis of a severe or unstable medical illness that precludes safe participation in the study by a healthcare practitioner
  • diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder; or current acute psychosis or mania by a healthcare practitioner
  • participants with moderate or high risk of suicide upon screening by the Columbia Suicide Severity Rating Scale (C-SSRS)
  • have an inability to communicate in English fluently enough to complete the questionnaire.

Treatment and study plan

Mantram repetition program

Behavioral

Week 1: Define and describe the characteristics of a "mantram" as taught by Eknath Easwaran and how it relates to posttraumatic stress (PTSD) Week 2: Identify ways to choose and use mantram repetition for training attention and targeting craving.

Introduction to substance craving and identify triggers for use. Week 3: Describe the relationship between the PTSD/stress response, mantram repetition and the "relaxation response" Week 4: Describe at least two benefits of slowing down versus automatic pilot for stress reduction Week 5: Describe at least two benefits of one-pointed attention versus multitasking for stress reduction Week 6: Demonstrate how one-pointed attention and slowing down complement each other for making healthy choices Week 7: List at least five strategies for making mantram repetition a part of your life Week 8: Discuss applications of mantram repetition, one-pointed attention and slowing down for overall health and substance use

Primary outcomes

  1. Rate of retention in the group

    Time frame: 8 weeks

    Number of sessions completed for each participant, number of participants who withdraw and/or had non-attendance after enrollment in the study

Secondary outcomes

  1. Alcohol consumption

    Time frame: 8 weeks

    Weekly alcohol consumption will be monitored using the timeline follow back interview

  2. Drug consumption

    Time frame: 8 weeks

    Weekly drug consumption will be monitored using the timeline follow back interview

  3. CAPS-5 PTSD Symptom Severity (past month)

    Time frame: Week 4, Week 8, Week 12 follow up

    Changes in PTSD symptoms and wellbeing will be monitored using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at the mid- and end-point of therapy and at follow up; 30-item questionnaire assessing 20 PTSD symptoms and overall PTSD severity; severity scale ranges from 0 to 4 with 0 = absence in symptoms to 4 being the highest symptom severity

  4. Self-Rated PTSD Symptom Severity

    Time frame: 8 weeks

    Changes in PTSD symptoms severity will be monitored weekly using the PTSD Checklist for DSM-5 (PCL-5); 20-item checklist with scale from 0 to 4, where 0 means no endorsement and 4 means greatest level of PTSD-related distress.

  5. Wellbeing

    Time frame: Baseline; Week 4; Week 8; Week 12 follow up. Scale Title: 12-item Short Form Health Survey , Minimum value: 0 , Maximum value : 100. The higher the score the better the outcome.

    Changes in wellbeing will be monitored at 3 time points using the 12-item Short Form Health Survey (SF-12)

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

Virtual Mantram Repetition Program for Patients With Posttraumatic Stress Disorder and Substance Use Disorders

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2021
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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