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

Psychotic Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05726617
• Other study ID #: MP-12-2019-1564
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 24, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Ciusss de L'Est de l'Île de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 31, 2024
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse
• Mental Disorders
• Mental Health Disorder
• Psychotic Disorders

Intervention

Behavioral:
• Avatar Intervention
8 weekly sessions of 60 minutes.

Locations

Country	Name	City	State
Canada	Research center of the Institut universitaire en santé mentale de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Ciusss de L'Est de l'Île de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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