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

Primary Purpose

Psychotic Disorders, Cannabis Use Disorder, Mental Health Disorder

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Avatar Intervention
Sponsored by
Ciusss de L'Est de l'Île de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring cannabis, virtual reality intervention, psychotic disorders, substance use disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research center of the Institut universitaire en santé mentale de Montréal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Avatar Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
February 3, 2023
Last Updated
August 31, 2023
Sponsor
Ciusss de L'Est de l'Île de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT05726617
Brief Title
Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders
Acronym
Avatar-CUD
Official Title
A Pilot Study : Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Psychotic Disorders and/or Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 24, 2019 (Actual)
Primary Completion Date
August 11, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ciusss de L'Est de l'Île de Montréal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Cannabis Use Disorder, Mental Health Disorder
Keywords
cannabis, virtual reality intervention, psychotic disorders, substance use disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pilot clinical trial, single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Avatar Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Avatar Intervention
Other Intervention Name(s)
Avatar-CUD
Intervention Description
8 weekly sessions of 60 minutes.
Primary Outcome Measure Information:
Title
Change in cannabis use (Timeline Follow-Back)
Description
A standardized tool consisting of asking the patients how many joints they smoked each day of the week during the past week.
Time Frame
Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
Secondary Outcome Measure Information:
Title
Change in the severity of the cannabis use disorder (Cannabis Use Problems Identification Test - CUPIT)
Description
16-item self-reported questionnaire assessing cannabis use and dependence; Range 3-82, higher values indicating a more severe cannabis use disorder
Time Frame
Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
Title
Change in quality of life (Quality of Life Scale -QLS)
Description
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
Time Frame
Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
Title
Motivation to change cannabis use (Marijuana Ladder)
Description
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
Time Frame
Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up
Title
Change in psychiatric symptoms (Positive And Negative Syndrome Scale - PANSS)
Description
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
Time Frame
Within 1 week before treatment, within 1 week after treatment as well as 3- 6- and 12-months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Dumais, MD, PhD
Organizational Affiliation
University of Montreal, Institut universitaire en santé mentale de Montréal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stéphane Potvin, PhD
Organizational Affiliation
University of Montreal, Institut universitaire en santé mentale de Montréal
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert-Paul Juster
Organizational Affiliation
University of Montreal, Institut universitaire en santé mentale de Montréal
Official's Role
Study Chair
Facility Information:
Facility Name
Research center of the Institut universitaire en santé mentale de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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