Virtual Mantram Program for Patients With PTSD and SUD
- Conditions
- Post Traumatic Stress DisorderSubstance Use Disorders
- Interventions
- Behavioral: Mantram repetition program
- Registration Number
- NCT05058963
- Lead Sponsor
- Centre for Addiction and Mental Health
- 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mantram repetition program Mantram repetition program Weekly 90 minute virtual group therapy sessions for 8 weeks run by two faciliators and will consist of 5-8 participants.
- Primary Outcome Measures
Name Time Method Rate of retention in the group 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 Outcome Measures
Name Time Method Drug consumption 8 weeks Weekly drug consumption will be monitored using the timeline follow back interview
Self-Rated PTSD Symptom Severity 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.
CAPS-5 PTSD Symptom Severity (past month) 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
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. Changes in wellbeing will be monitored at 3 time points using the 12-item Short Form Health Survey (SF-12)
Alcohol consumption 8 weeks Weekly alcohol consumption will be monitored using the timeline follow back interview
Trial Locations
- Locations (1)
Centre for Addiction and Mental Health
🇨🇦Toronto, Ontario, Canada