Virtual Mantram Program for Patients With PTSD and SUD
Primary Purpose
Post Traumatic Stress Disorder, Substance Use Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mantram repetition program
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Post Traumatic Stress Disorder, PTSD, Trauma, Substance Use Disorder, SUD, Substance Abuse, Mantram, Group therapy
Eligibility Criteria
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.
Sites / Locations
- Centre for Addiction and Mental HealthRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mantram repetition program
Arm Description
Weekly 90 minute virtual group therapy sessions for 8 weeks run by two faciliators and will consist of 5-8 participants.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Alcohol consumption
Weekly alcohol consumption will be monitored using the timeline follow back interview
Drug consumption
Weekly drug consumption will be monitored using the timeline follow back interview
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
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.
Wellbeing
Changes in wellbeing will be monitored at 3 time points using the 12-item Short Form Health Survey (SF-12)
Full Information
NCT ID
NCT05058963
First Posted
July 13, 2021
Last Updated
March 15, 2023
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT05058963
Brief Title
Virtual Mantram Program for Patients With PTSD and SUD
Official Title
Virtual Mantram Repetition Program for Patients With Posttraumatic Stress Disorder and Substance Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Substance Use Disorders
Keywords
Post Traumatic Stress Disorder, PTSD, Trauma, Substance Use Disorder, SUD, Substance Abuse, Mantram, Group therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mantram repetition program
Arm Type
Experimental
Arm Description
Weekly 90 minute virtual group therapy sessions for 8 weeks run by two faciliators and will consist of 5-8 participants.
Intervention Type
Behavioral
Intervention Name(s)
Mantram repetition program
Intervention Description
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 Outcome Measure Information:
Title
Rate of retention in the group
Description
Number of sessions completed for each participant, number of participants who withdraw and/or had non-attendance after enrollment in the study
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Alcohol consumption
Description
Weekly alcohol consumption will be monitored using the timeline follow back interview
Time Frame
8 weeks
Title
Drug consumption
Description
Weekly drug consumption will be monitored using the timeline follow back interview
Time Frame
8 weeks
Title
CAPS-5 PTSD Symptom Severity (past month)
Description
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
Time Frame
Week 4, Week 8, Week 12 follow up
Title
Self-Rated PTSD Symptom Severity
Description
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.
Time Frame
8 weeks
Title
Wellbeing
Description
Changes in wellbeing will be monitored at 3 time points using the 12-item Short Form Health Survey (SF-12)
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Hassan, MD, MPH
Phone
416-535-8501
Ext
34051
Email
Ahmed.Hassan@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Abigail Amartey, MPH
Phone
416-535-8501
Ext
33651
Email
abigail.amartey@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Hassan, MD, MPH
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Hassan, MD, MPH
Phone
416-535-8501
Ext
34051
Email
ahmed.hassan@camh.ca
First Name & Middle Initial & Last Name & Degree
Abigail Amartey, MPH
Phone
416-535-8501
Ext
33651
Email
abigail.amartey@camh.ca
First Name & Middle Initial & Last Name & Degree
Ahmed Hassan, MD, MPH
12. IPD Sharing Statement
Learn more about this trial
Virtual Mantram Program for Patients With PTSD and SUD
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