Virtual Mantram Program for Patients With PTSD and SUD

NCT05058963 | Completed

• 1 other identifier: 018/2019
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder; Substance Use Disorders

Keywords

Post Traumatic Stress Disorder; PTSD; Trauma; Substance Use Disorder; SUD; Substance Abuse; Mantram; Group therapy

Outcome Measures

Primary Outcomes (1)

• Rate of retention in the group

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

  8 weeks

Secondary Outcomes (5)

• Alcohol consumption

  8 weeks

• Drug consumption

  8 weeks

• CAPS-5 PTSD Symptom Severity (past month)

  Week 4, Week 8, Week 12 follow up

• Self-Rated PTSD Symptom Severity

  8 weeks

• Wellbeing

  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.

Study Arms (1)

Mantram repetition program

EXPERIMENTAL

Weekly 90 minute virtual group therapy sessions for 8 weeks run by two faciliators and will consist of 5-8 participants.

Behavioral: Mantram repetition program

Interventions

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

Mantram repetition program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (1)

• Ferkul S, Agabani Z, Minami O, Bormann J, Le Foll B, Lobo L, Hassan AN. The acceptability and feasibility of a virtual mantram program for patients with posttraumatic stress disorder and substance use disorders: mixed method results. BMC Complement Med Ther. 2024 Jan 2;24(1):9. doi: 10.1186/s12906-023-04312-1.

  PMID: 38166894 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Ahmed Hassan, MD, MPH

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: September 28, 2021
• Study Start: May 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: April 25, 2024

Record last verified: 2023-01

Locations

CA (1)