Clinical trial NCT05058963: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Substance Use Disorders
Keywords: Post Traumatic Stress Disorder
PTSD
Trauma
Substance Use Disorder
SUD
Substance Abuse
Mantram
Group therapy
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rate of retention in the group
timeFrame: 8 weeks
Secondary outcomes:
measure: Alcohol consumption
timeFrame: 8 weeks
measure: Drug consumption
timeFrame: 8 weeks
measure: CAPS-5 PTSD Symptom Severity (past month)
timeFrame: Week 4, Week 8, Week 12 follow up
measure: Self-Rated PTSD Symptom Severity
timeFrame: 8 weeks
measure: Wellbeing
timeFrame: 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.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Ahmed Hassan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: