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

Study Overview
=================
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.

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

Conditions
-----------------
Psychotic Disorders, Cannabis Use Disorder, Mental Health Disorder

Intervention / Treatment
-----------------
* Behavioral: Avatar Intervention


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: pilot clinical trial, single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Avatar Intervention<br>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<br>* 8 weekly sessions of 60 minutes.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cannabis, virtual reality intervention, psychotic disorders, substance use disorders