A Cannabis Harm Reduction e-Intervention for Young Cannabis Users With Early Psychosis (CHAMPS)

A Randomized Pilot Trial of a Cannabis Harm Reduction e-Intervention (CHAMPS) for Young Adults With Early Psychosis Who Use Cannabis

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.

Study Overview

• Status: Completed
• Conditions: Marijuana Use; Young Adult; Psychotic Disorder
• Intervention / Treatment: Behavioral: CHAMPS

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre Early Psychosis Intervention Program, Unit 24, 1403-29 Street NW
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2E2
      • Nova Scotia Early Psychosis Program, 3rd Floor, Abbie Lane Bldg 5909 Veterans' Memorial Lane
  • Quebec
    • Montreal, Quebec, Canada, H1N 3M5
      • Clinic Connec-T - Institut universitaire en santé mentale de Montréal, 7401 rue Hochelaga
    • Montreal, Quebec, Canada, H2X 3E4
      • Clinique JAP, Centre hospitalier de l'Université de Montréal, 1051, rue Sanguinet
    • Québec, Quebec, Canada, G1J 2G3
      • Clinic Notre-Dame des Victoires - Centre de Recherche CERVO, 2601 chemin de la Canardière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No

Description

Participants must meet all following inclusion criteria:

• diagnosed with any psychotic disorder, which can include schizophrenia, schizoaffective disorder, bipolar disorder with psychotic features, delusional disorder, psychotic disorder not otherwise specified, brief psychotic disorder and substance-induced psychotic disorder;
• has been followed at an early psychosis clinic for a minimum of 3 months;
• currently using cannabis (at least one time in the past 4 weeks);
• is open to changing cannabis-related practices;
• able to provide full informed consent;
• available for the whole study duration and able to comply with study procedures;
• able to comprehend French or English.

Participants are excluded if any of these exclusion criteria is met:

• pregnancy, nursing or any medical condition that in the opinion of the psychiatrist precludes safe participation in the study or the ability to provide fully informed consent;
• any disabling, unstable or acute mental condition that in the opinion of the psychiatrist precludes safe participation in the study or the ability to provide fully informed consent;
• any legal/judicial status/issue, pending legal action, or other reasons in the opinion of the study team that might prevent completion of the study;
• presence of a substance use disorder that, in the opinion of the psychiatrist, precludes safe participation in the study (e.g., very unstable or severe substance use disorder);
• currently seeking psychological or pharmacological treatment for cannabis use disorder to cease or decrease his/her use;
• currently participating in another specific cannabis-focused intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CHAMPS and EIS; 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).	Behavioral: CHAMPS; 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.; Other Names: Psychotherapy; Technology-based psychosocial intervention
No Intervention: EIS alone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: Ministere de la Sante et des Services Sociaux
• Investigators: Principal Investigator: Didier Jutras-Aswad, MD, MSc, Centre hospitalier de l'Université de Montréal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2021
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 24, 2023

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Psychosis; Cannabis; Youth
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders; Marijuana Abuse; Marijuana Use
• Other Study ID Numbers: 20.433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No