Avatar-CUD: RCT Comparing Avatar Intervention to Supportive Intervention to Reduce Cannabis Use in Patients With Psychotic Disorders
Study Details
Study Description
Brief Summary
The goal of this clinical trial is to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacy over supportive intervention to reduce cannabis use in patients with psychotic disorders. The primary outcomes are reductions in cannabis use, cannabis use disorder severity, and increased quality of life.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Psychotic disorders (PD) are characterized by a loss of contact with reality. Cannabis use is one of the key factors leading to psychiatric re-hospitalization in PD. In these populations, cannabis use is also associated with depressive symptoms, medication non-compliance, hostility as well as reduced quality of life. Unfortunately, there is no evidence-based intervention available for the treatment of cannabis use disorder (CUD) in this population. Novel interventions for CUD are thus critically needed. Virtual reality-based therapies are a promising avenue that allow patients to try novel strategies in real time instead of having to learn abstract rules. To fill a clinical need, our team has created a distinctive intervention for CUD in patients with PD. The Avatar Intervention displays strong experiential and relational components that are crucially missing in conventional interventions. This proposal thus aims to conduct a single-blind randomized controlled trial to verify whether the Avatar Intervention has greater efficacity over a supportive intervention on several outcomes, including reductions in cannabis use and CUD severity, and increased quality of life. We will also explore whether the greater improvements attributable to the Avatar Intervention persist in time, and perform analyses on sex/gender, motivation to change cannabis habits, psychotic relapses, and THC metabolite levels. Noteworthily, cannabis-related hospitalizations have been identified as one of the core indicators to measure the success of cannabis legalization. As a result, there is a pressing need to design innovative interventions that could have a significant impact on this costly and prime outcome. As there is no evidence-based therapeutic options for CUD in patients with PD, the current trial will contribute to the validation of a novel approach and create new therapeutic possibilities.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Avatar Intervention The Avatar Intervention will take place over 8 consecutive weeks, with one session per week. Additional sessions (up to a maximum of 4 sessions) will be offered if needed. Each session will last approximately 60 minutes. The goal of the intervention will be to help you reduce cravings related to your cannabis use with the use of virtual reality and avatars. |
Other: Avatar Intervention
8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.
Other Names:
|
| Active Comparator: Addiction supportive intervention The Addiction supportive intervention will take place over 8 consecutive weeks, with one session per week. Additional sessions (up to a maximum of 4 sessions) will be offered if needed. Each session will last approximately 60 minutes. The goal of the intervention will be to help you reduce cravings related to your cannabis use. |
Other: Addiction supportive intervention
8 weekly sessions of 60 minutes. Possibility of 4 additional sessions.
|
Outcome Measures
Primary Outcome Measures
- Change in cannabis use (Timeline Follow-Back) [Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months]
A standardized tool consisting of asking the patients how many joints they smoked each day of the week during the past week.
Secondary Outcome Measures
- Change in the severity of the cannabis use disorder (Cannabis Use Problems Identification Test - CUPIT) [Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months]
16-item self-reported questionnaire assessing cannabis use and dependence; Range 3-82, higher values indicating a more severe cannabis use disorder
- Change in quality of life(Quality of Life Enjoyment and Satisfaction Questionnaire - QLESQ-SF & Quality of Life Scale - QLS) [Within 1 week before treatment, within 1 week after treatment, follow-ups at 3 months, 6 months and 12 months]
QLESQ-SF: 16-item self-reported scale measuring enjoyment and satisfaction experienced during the past week in various areas of daily functioning; Range 14-70, Higher values indicate a better satisfaction of life QLS: 21-item scale based on a semistructured interview designed to assess deficit symptoms; Range 0-126, higher values indicate a better quality of life
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males or females over 18 years of age who meet the DSM-5 criteria for CUD (≥4 criteria) ;
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Patients will meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, or bipolar disorder with psychotic symptoms. Diagnoses will be established with the Structured Interview for DSM-5 (SCID-5).
Exclusion Criteria:
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Current SUD for a substance other than cannabis ;
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Ongoing pharmacological or psychological treatment for CUD ;
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Ongoing detoxification for cannabis withdrawal ;
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Presence of neurological disorders ;
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Presence of a severe and unstable physical illness ;
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Inability to provide consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research center of the Institut universitaire en santé mentale de Montréal | Montreal | Quebec | Canada | H1N 3M5 |
Sponsors and Collaborators
- Ciusss de L'Est de l'Île de Montréal
- Canadian Institutes of Health Research (CIHR)
Investigators
- Principal Investigator: Alexandre Dumais, MD, PhD, University of Montreal, Institut universitaire en santé mentale de Montréal
- Principal Investigator: Stephane Potvin, PhD, University of Montreal, Institut universitaire en santé mentale de Montréal
- Study Chair: Emmanuel Stip, MD, MSc, United Arab Emirates University
- Study Chair: Amal Abdel Baki, MD, MSc, University of Montreal, Centre hospitalier de l'Université de Montréal
- Study Chair: Robert-Paul Juster, PhD, University of Montreal, Institut universitaire en santé mentale de Montréal
- Study Chair: Marie-Hélène Goulet, PhD, University of Montreal, Institut universitaire en santé mentale de Montréal
- Study Chair: Luigi De Benedictis, MD, Institut universitaire en santé mentale de Montréal
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MP-12-2023-3234