Psychotic Disorders Clinical Trial
— Avatar-CUDOfficial title:
A Pilot Study : Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Psychotic Disorders and/or Mood Disorders
Verified date | February 2024 |
Source | Ciusss de L'Est de l'Île de Montréal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Research center of the Institut universitaire en santé mentale de Montréal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Ciusss de L'Est de l'Île de Montréal |
Canada,
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 |
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