Virtual Mantram Program for Patients With PTSD and SUD

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05058963
• Other study ID #: 018/2019
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: January 2023
• Source: Centre for Addiction and Mental Health
• Contact: Ahmed Hassan, MD, MPH
• Phone: 416-535-8501
• Email: Ahmed.Hassan[@]camh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Mantram repetition program
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

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Alcohol consumption	Weekly alcohol consumption will be monitored using the timeline follow back interview	8 weeks
Secondary	Drug consumption	Weekly drug consumption will be monitored using the timeline follow back interview	8 weeks
Secondary	CAPS-5 PTSD Symptom Severity (past month)	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	Week 4, Week 8, Week 12 follow up
Secondary	Self-Rated PTSD Symptom Severity	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.	8 weeks
Secondary	Wellbeing	Changes in wellbeing will be monitored at 3 time points using the 12-item Short Form Health Survey (SF-12)	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.