Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders

NCT ID: NCT05726617

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-24
• Study Completion Date: 2024-12-31

Brief Summary

This is a proof-of-concept of a new Virtual Reality (VR) Avatar Intervention for Cannabis Use Disorders (CUD) in patients with psychotic disorders and/or mood disorders. The primary outcomes are reductions in cannabis use, cannabis use disorder severity, and increased quality of life.

Detailed Description

Cannabis use disorder (CUD) is a complex issue, even more so when it is comorbid with a psychotic disorder or a mood disorder. Indeed, this population seems more vulnerable to this substance since the incidence of developing CUD is five to six times higher compared to the general population. In these populations, cannabis use is one of the key factors leading to psychiatric re-hospitalization. It is 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 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 concepts. In response to this clinical need, our team has created a distinctive intervention for CUD in patients with psychotic disorders and/or mood disorders. The Avatar Intervention displays strong experiential and relational components that are crucially missing in conventional interventions. This proposal thus aims to conduct a proof-of-concept to assess the efficacity of Avatar Intervention for CUD in patients with psychotic disorders and/or mood disorders. The primary objective of this open trial will be to determine whether cannabis-related outcomes (i.e. frequency and quantity of use) diminish after treatment as well as 3- 6- and 12-months follow-up. As for secondary objectives, the investigator will seek to determine the effect of the intervention on motivation to change, severity of cannabis dependence, psychiatric symptoms (mood and psychotic) and whether quality of life improves after treatment, at 3- 6- and 12-months follow-up. As there is no evidence-based therapeutic options for CUD in patients with psychotic disorders and/or mood disorders, the current trial will contribute to the validation of a novel approach and create new therapeutic possibilities.

Conditions

Psychotic Disorders; Cannabis Use Disorder; Mental Health Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Avatar Intervention

The Avatar Intervention will take place over 8 consecutive weeks, with one session per week. 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.

Group Type: EXPERIMENTAL

Avatar Intervention

Intervention Type: BEHAVIORAL

8 weekly sessions of 60 minutes.

Interventions

Avatar Intervention

8 weekly sessions of 60 minutes.

Intervention Type: BEHAVIORAL

Other Intervention Names

Avatar-CUD

Eligibility Criteria

Inclusion Criteria

• Males or females over 18 years of age who meet the DSM-5 criteria for CUD (≥4 criteria) ;
• Patients will meet the DSM-5 criteria for schizophrenia, schizoaffective disorder, bipolar disorder and major depression. Diagnoses will be established with the Structured Interview for DSM-5 (SCID-5).

Exclusion Criteria

• Ongoing pharmacological or psychological treatment for CUD ;
• Ongoing detoxification for cannabis withdrawal ;
• Presence of neurological disorders ;
• Presence of a severe and unstable physical illness ;
• Inability to provide consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre Dumais, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Montreal, Institut universitaire en santé mentale de Montréal

Stéphane Potvin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Montreal, Institut universitaire en santé mentale de Montréal

Robert-Paul Juster

Role: STUDY_CHAIR

University of Montreal, Institut universitaire en santé mentale de Montréal

Locations

Research center of the Institut universitaire en santé mentale de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

MP-12-2019-1564

Identifier Type: -

Identifier Source: org_study_id