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

A Pilot Study : Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Psychotic Disorders and/or Mood Disorders

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Psychotic Disorders; Mental Health Disorder; Cannabis Use Disorder
• Intervention / Treatment: Behavioral: Avatar Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1N 3M5
      • Research center of the Institut universitaire en santé mentale de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Avatar Intervention; 8 weekly sessions of 60 minutes.; Other Names: Avatar-CUD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cannabis use (Timeline Follow-Back)	A standardized tool consisting of asking the patients how many joints they smoked each day of the week during the past week.	Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the severity of the cannabis use disorder (Cannabis Use Problems Identification Test - CUPIT)	16-item self-reported questionnaire assessing cannabis use and dependence; Range 3-82, higher values indicating a more severe cannabis use disorder	Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
Change in quality of life (Quality of Life Scale -QLS)	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	Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
Motivation to change cannabis use (Marijuana Ladder)	Diagram of a ladder with 10 "rungs," several of which are anchored by verbal labels of different degrees of readiness to change (pre-contemplation, contemplation, preparation, action, maintenance); higher values indicates a high degrees of readiness to change	Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
Change in psychiatric symptoms (Positive And Negative Syndrome Scale - PANSS)	Positive And Negative Syndrome Scale: 30-item semi-structured interview investigating overall symptoms severity of schizophrenia in the last week; Subscales: Positive (7-49), Negative (7-49), General (16-112), Total score (subscales summed; 30-210); higher value indicates a worse symptomatology	Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up

Collaborators and Investigators

• Sponsor: Ciusss de L'Est de l'Île de Montréal
• Investigators: Principal Investigator: Alexandre Dumais, MD, PhD, University of Montreal, Institut universitaire en santé mentale de Montréal; Principal Investigator: Stéphane Potvin, PhD, University of Montreal, Institut universitaire en santé mentale de Montréal; Study Chair: Robert-Paul Juster, University of Montreal, Institut universitaire en santé mentale de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Actual): August 11, 2022
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cannabis; substance use disorders; psychotic disorders; virtual reality intervention
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders; Marijuana Abuse
• Other Study ID Numbers: MP-12-2019-1564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No