Post Traumatic Stress DisorderNCT05058963
Virtual Mantram Program for Patients With PTSD and SUD
A study testing Mantram repetition program in people with Post Traumatic Stress Disorder and Substance Use Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Substance Use Disorders
- What is being tested?
- Mantram repetition program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Mantram Repetition Program for Patients With Posttraumatic Stress Disorder and Substance Use Disorders
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.
Read the 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.
- Being tested
- Mantram repetition program
- Keywords
- Post Traumatic Stress Disorder, PTSD, Trauma, Substance Use Disorder, SUD, Substance Abuse, Mantram, Group therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mantram repetition programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mantram repetition program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (5)
Alcohol consumption
Weekly alcohol consumption will be monitored using the timeline follow back interview
Measured: 8 weeks
Drug consumption
Weekly drug consumption will be monitored using the timeline follow back interview
Measured: 8 weeks
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
Measured: Week 4, Week 8, Week 12 follow up
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.
Measured: 8 weeks
Wellbeing
Changes in wellbeing will be monitored at 3 time points using the 12-item Short Form Health Survey (SF-12)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start1 May 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Hassan, MD, MPH, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058963
- Sponsor's protocol ID
- 018/2019
- Status last verified
- Jan 2023
- First submitted
- 13 Jul 2021
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38166894
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Mantram Repetition Program for Patients With Posttraumatic Stress Disorder and Substance Use Disorders
- ClinicalTrials.gov ID
- NCT05058963
- Acronym / sponsor ID
- 018/2019
- Keywords
- Post Traumatic Stress Disorder, PTSD, Trauma, Substance Use Disorder, SUD, Substance Abuse, Mantram, Group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 28 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mantram repetition program | Experimental | Behavioral: Mantram repetition programWeekly 90 minute virtual group therapy sessions for 8 weeks run by two faciliators and will consist of 5-8 participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mantram repetition programWeek 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 | Behavioural | Mantram repetition program |
Primary outcome
Rate of retention in the group
Time frame: 8 weeks
Number of sessions completed for each participant, number of participants who withdraw and/or had non-attendance after enrollment in the study
5 secondary outcomes
Alcohol consumption
Time frame: 8 weeks
Drug consumption
Time frame: 8 weeks
CAPS-5 PTSD Symptom Severity (past month)
Time frame: Week 4, Week 8, Week 12 follow up
Self-Rated PTSD Symptom Severity
Time frame: 8 weeks
Wellbeing
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Derived from this study: PubMed 38166894Ferkul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Hassan, MD, MPH principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mantram repetition program in people with Post Traumatic Stress Disorder and Substance Use Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of retention in the group (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05058963, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.