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Behavioral Intervention
Virtual Reality Cognitive Behavioral Therapy for Emotion Regulation
N/A
Recruiting
Led By Outi Linnaranta, MD, Ph.D
Research Sponsored by Douglas Mental Health University Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 10 minutes
Awards & highlights
Study Summary
This trial will test a new psychotherapy to help Inuit people in Montreal improve their emotion regulation, by comparing it to a self-management program.
Who is the study for?
This trial is for Inuit individuals living in Montreal, aged 14-60, who are mentally stable and have no history of psychosis or substance abuse. Participants must be comfortable with VR technology, not at risk of suicide or homicide, and able to communicate in English or French.Check my eligibility
What is being tested?
The study compares two groups: one receives a ten-week virtual reality-assisted cognitive-behavioral therapy (VR-CBT) for emotion regulation at a clinic; the other uses a VR self-management relaxation program at home. Outcomes will be measured through self-reports and physiological responses before and after treatment.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the VR headset, possible motion sickness related to VR use, temporary distress during emotional regulation exercises in psychotherapy sessions, but specific side effects will depend on individual tolerance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 10 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 10 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Emotion Regulation
Secondary outcome measures
Feasibility of interventions (attendance/useage)
Feasibility of interventions (treatment completion)
Psychiatric Symptoms (alcohol use disorder)
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: VR-CBTExperimental Treatment1 Intervention
A trained psychotherapist provides CBT-VR for up to 10 sessions over 10 weeks.
Group II: Self-managementActive Control1 Intervention
Participants use a commercial VR application at home for guided self-management at their own pace over 10 weeks.
Find a Location
Who is running the clinical trial?
McGill UniversityOTHER
395 Previous Clinical Trials
999,337 Total Patients Enrolled
1 Trials studying Emotion Regulation
20 Patients Enrolled for Emotion Regulation
MedTeqIndustry Sponsor
7 Previous Clinical Trials
478 Total Patients Enrolled
Douglas FoundationUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had epilepsy.I am between 14 and 60 years old.I haven't changed my mental health medications in the last 4 weeks.I am either younger than 14 or older than 60.I have never had heart problems.I do not have any health conditions that could interfere with the trial.
Research Study Groups:
This trial has the following groups:- Group 1: VR-CBT
- Group 2: Self-management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor open to participants of an advanced age?
"This clinical trial stipulates that participants must be aged between 14 and 60, as per the specified inclusion criteria."
Answered by AI
For whom is this trial open to participate in?
"Candidates for this trial should possess emotion regulation abilities and fulfill the age requirements of 14-60. In total, 40 participants are needed to complete the study."
Answered by AI
Is there availability to join this experiment as a participant?
"The clinical trial's details on clinicaltrials.gov indicate that it is not presently recruiting patients, as the study was initially posted in January 15th 2023 and last updated on November 28th 2022. However, there are currently another 28 trials actively enrolling candidates at this time."
Answered by AI
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