A Cannabis Harm Reduction e-Intervention for Young Cannabis Users With Early Psychosis
- Conditions
- Young AdultPsychotic DisorderMarijuana Use
- Registration Number
- NCT04968275
- Lead Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Brief Summary
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.
- Detailed Description
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:
* CHAMPS and EIS
* EIS alone
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Completion rates Week 12 Proportions of participants completing at least the first four CHAMPS modules or with ongoing participation in EIS.
Retention rates Week 6 Proportions of participants retained in the trial (completing all endpoint assessments)
- Secondary Outcome Measures
Name Time Method Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study Weeks -4 to 18 Trial parameters
Acceptability (CHAMPS usage data) Weeks -2-0 (baseline) to 10 Number of CHAMPS modules completed, time spent on each module, time elapsed between module initiation and completion, total time spent on CHAMPS
Participant satisfaction Weeks 6 and 12 Score on the Client Satisfaction Questionnaire-I
Efficacy (use of cannabis protective behavioral strategies) Weeks -2-0 (baseline), 6, 12 and 18 Change between endpoint and baseline scores on the Short Form Protective Behavioral Strategies-Marijuana questionnaire.
Efficacy (motivation to change cannabis protective behavioral strategies) Weeks -2-0 (baseline), 6, 12 and 18 Change between endpoint and baseline scores on the Readiness-to-Change Questionnaire modified for cannabis use
Trial Locations
- Locations (5)
Foothills Medical Centre Early Psychosis Intervention Program, Unit 24, 1403-29 Street NW
🇨🇦Calgary, Alberta, Canada
Nova Scotia Early Psychosis Program, 3rd Floor, Abbie Lane Bldg 5909 Veterans' Memorial Lane
🇨🇦Halifax, Nova Scotia, Canada
Clinic Connec-T - Institut universitaire en santé mentale de Montréal, 7401 rue Hochelaga
🇨🇦Montreal, Quebec, Canada
Clinique JAP, Centre hospitalier de l'Université de Montréal, 1051, rue Sanguinet
🇨🇦Montreal, Quebec, Canada
Clinic Notre-Dame des Victoires - Centre de Recherche CERVO, 2601 chemin de la Canardière
🇨🇦Québec, Quebec, Canada
Foothills Medical Centre Early Psychosis Intervention Program, Unit 24, 1403-29 Street NW🇨🇦Calgary, Alberta, Canada