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| Name | Class |
|---|---|
| Ministere de la Sante et des Services Sociaux | OTHER |
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Cannabis users who experienced a psychosis are particularly vulnerable to cannabis-related harms, which can include worse psychotic symptoms and more hospitalizations. Unfortunately, few psychosocial interventions exist that aim to decrease these harms. Instead, most focus on ceasing cannabis use which is rarely appealing to cannabis users. Furthermore, face-to-face psychotherapy often remains inaccessible to people with psychosis mostly due to lack of trained clinicians. Alternatives such as e-interventions have the potential to increase access to treatment and decrease clinicians' workload. Among cannabis harm reduction approaches are the protective behavioural strategies. These strategies do not encourage nor discourage cannabis use. Instead, they recommend behaviours for safer cannabis use. For example, these strategies include: 1) avoid driving a car under the influence of cannabis, 2) avoid mixing cannabis with other drugs and 3) purchase cannabis only from a trusted source. In the present pan-Canadian study, we will test the first e-intervention called CHAMPS (Cannabis Harm-reducing App for Managing Practices Safely) for cannabis harm reduction adapted for young adult cannabis users who experienced a psychosis. CHAMPS is a smartphone application that includes 17 strategies for safer cannabis use, a personalized consumption goal and a consumption journal. The goals of this study are 1) to confirm whether CHAMPS is acceptable to participants and 2) to test whether it works, notably by positively impacting participants' health and cannabis consumption habits.
This multicentric, two-arm, open-labelled, pilot randomized controlled trial involves 100 young cannabis users who experienced a psychosis and are followed in an early intervention service (EIS) in Canada. Participants will be randomized in a 1:1 ratio to one of two interventions:
The smartphone application CHAMPS contains six modules (each lasting 15-20 min, weeks 1 to 6) and a booster session (20 min, week 10) based on motivational interviewing and harm reduction approaches. EIS consists of standard of care and psychoeducation material on cannabis use offered in first episode psychosis clinics and administered through in-person visits and/or phone or video calls.
All participants will be assessed for a follow-up at weeks 6, 12 and 18. Data on mental health, substance use, cannabis dependence severity, cannabis-related problems, quality of life and health care service utilization will be obtained through questionnaires and medical charts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHAMPS and EIS | Experimental | The Cannabis Harm-reducing App for Managing Practices Safely (CHAMPS) is a brief harm reduction e-intervention based on the principles of motivational interviewing and harm reduction approaches. This e-intervention will be completed by the participant using a smart phone. There will be a total of six individual sessions each lasting 15-20 min. There will be one booster session offered at 4 weeks post-intervention to review goal setting, evaluate motivation around changing cannabis use practices. This e-intervention will be administered adjunctively to psychosis early intervention services (EIS). |
|
| EIS alone | No Intervention | Early intervention services (EIS) for psychosis will be offered as per standard of care at participating clinical sites. Theses services vary but typically include pharmacotherapy and individual and/or group psychotherapy. Any visits and services offered in the EIS arm will be considered 'usual care' and administered either through in-person clinic visits, phone calls, or video calls. Relevant service information will be collected for study purposes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHAMPS | Behavioral | CHAMPS provides personalized feedback on participants' cannabis use behaviors and supports strategies to change such behaviors. It comprises six modules measuring the use of cannabis protective behavioural strategies, exploring the possible benefits of changing cannabis practices and setting and monitoring the reach of a SMART cannabis use goal. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rates | Proportions of participants completing at least the first four CHAMPS modules or with ongoing participation in EIS. | Week 12 |
| Retention rates | Proportions of participants retained in the trial (completing all endpoint assessments) | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability (CHAMPS usage data) | Number of CHAMPS modules completed, time spent on each module, time elapsed between module initiation and completion, total time spent on CHAMPS | Weeks -2-0 (baseline) to 10 |
| Participant satisfaction |
| Measure | Description | Time Frame |
|---|---|---|
| Cannabis-related problems | Total score on the Marijuana Problems Scale | Weeks -2-0 (baseline), 6, 12 and 18 |
| Cannabis use | Past two weeks cannabis use according to the Timeline Follow-Back Questionnaire |
Participants must meet all following inclusion criteria:
Participants are excluded if any of these exclusion criteria is met:
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| Name | Affiliation | Role |
|---|---|---|
| Didier Jutras-Aswad, MD, MSc | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre Early Psychosis Intervention Program, Unit 24, 1403-29 Street NW | Calgary | Alberta | T2N 2T9 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42423495 | Derived | Mahroug A, Lachance-Touchette P, Coronado-Montoya S, Abdel-Baki A, Cote J, Crocker C, Crockford DN, Daneault JG, Dubreucq S, Dussault-Laurendeau M, Fischer B, Lecomte T, L'Heureux S, Ouellet-Plamondon C, Roy MA, Tatar O, Tibbo P, Villeneuve M, Wittevrongel A, Jutras-Aswad D. Correlates of Engagement and Associations with Outcomes in a Cannabis Harm Reduction Mobile App for Youth with First-Episode Psychosis: Exploratory Findings from the CHAMPS Pilot Randomized Controlled Trial. JMIR Form Res. 2026 Jul 1. doi: 10.2196/84836. Online ahead of print. | |
| 38109196 |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D000074609 | Marijuana Use |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
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| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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two-arm parallel, open-labelled, pilot randomized controlled trial
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Group assignment will not be masked after randomization, but it will be at the data analysis stage.
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|
|
Score on the Client Satisfaction Questionnaire-I
| Weeks 6 and 12 |
| Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study | Trial parameters | Weeks -4 to 18 |
| Efficacy (use of cannabis protective behavioral strategies) | Change between endpoint and baseline scores on the Short Form Protective Behavioral Strategies-Marijuana questionnaire. | Weeks -2-0 (baseline), 6, 12 and 18 |
| Efficacy (motivation to change cannabis protective behavioral strategies) | Change between endpoint and baseline scores on the Readiness-to-Change Questionnaire modified for cannabis use | Weeks -2-0 (baseline), 6, 12 and 18 |
| Weeks -2-0 (baseline), 6, 12 and 18 |
| Other drug use | Past two weeks other drug use according to the Timeline Follow-Back Questionnaire | Weeks -2-0 (baseline), 6, 12 and 18 |
| Psychotic symptoms | Total score on the Positive and Negative Syndrome Scale | Weeks -2-0 (baseline), 6, 12 and 18 |
| Severity of cannabis dependence | Total score on the Severity of Dependence Scale | Weeks -2-0 (baseline), 6, 12 and 18 |
| Social support | Total score on the Social Provisions Scale | Weeks -2-0 (baseline) |
| Health service utilization | Past month number of emergency visits and days of hospitalization confirmed by medical record abstraction | Weeks -2-0 (baseline), 6, 12 and 18 |
| Safety (adverse events) | Adverse events and severe adverse events related or not to the study intervention | Weeks 6, 12 and 18 |
| Nova Scotia Early Psychosis Program, 3rd Floor, Abbie Lane Bldg 5909 Veterans' Memorial Lane |
| Halifax |
| Nova Scotia |
| B3H 2E2 |
| Canada |
| Clinic Connec-T - Institut universitaire en santé mentale de Montréal, 7401 rue Hochelaga | Montreal | Quebec | H1N 3M5 | Canada |
| Clinique JAP, Centre hospitalier de l'Université de Montréal, 1051, rue Sanguinet | Montreal | Quebec | H2X 3E4 | Canada |
| Clinic Notre-Dame des Victoires - Centre de Recherche CERVO, 2601 chemin de la Canardière | Québec | Quebec | G1J 2G3 | Canada |
| Derived |
| Coronado-Montoya S, Abdel-Baki A, Cote J, Crockford D, Dubreucq S, Fischer B, Lachance-Touchette P, Lecomte T, L'Heureux S, Ouellet-Plamondon C, Roy MA, Tatar O, Tibbo P, Villeneuve M, Wittevrongel A, Jutras-Aswad D. Evaluation of a Cannabis Harm Reduction Intervention for People With First-Episode Psychosis: Protocol for a Pilot Multicentric Randomized Trial. JMIR Res Protoc. 2023 Dec 18;12:e53094. doi: 10.2196/53094. |
| D064419 | Chemically-Induced Disorders |