A Cannabis Harm Reduction e-Intervention for Young Cannabis Users With Early Psychosis (CHAMPS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04968275|
Recruitment Status : Enrolling by invitation
First Posted : July 20, 2021
Last Update Posted : December 13, 2022
|Condition or disease||Intervention/treatment||Phase|
|Psychotic Disorder Marijuana Use Young Adult||Behavioral: CHAMPS||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||two-arm parallel, open-labelled, pilot randomized controlled trial|
|Masking:||None (Open Label)|
|Masking Description:||Group assignment will not be masked after randomization, but it will be at the data analysis stage.|
|Official Title:||A Randomized Pilot Trial of a Cannabis Harm Reduction e-Intervention (CHAMPS) for Young Adults With Early Psychosis Who Use Cannabis|
|Actual Study Start Date :||August 23, 2021|
|Estimated Primary Completion Date :||September 30, 2023|
|Estimated Study Completion Date :||September 30, 2023|
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).
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.
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.
- Completion rates [ Time Frame: Week 12 ]Proportions of participants completing at least the first four CHAMPS modules or with ongoing participation in EIS.
- Retention rates [ Time Frame: Week 6 ]Proportions of participants retained in the trial (completing all endpoint assessments)
- Acceptability (CHAMPS usage data) [ Time Frame: 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 [ Time Frame: Weeks 6 and 12 ]Score on the Client Satisfaction Questionnaire-I
- Numbers of participants who are referred, screened, eligible, consenting, randomized, initiating and completing the study [ Time Frame: Weeks -4 to 18 ]Trial parameters
- Efficacy (use of cannabis protective behavioral strategies) [ Time Frame: 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) [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]Change between endpoint and baseline scores on the Readiness-to-Change Questionnaire modified for cannabis use
- Cannabis-related problems [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]Total score on the Marijuana Problems Scale
- Cannabis use [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]Past two weeks cannabis use according to the Timeline Follow-Back Questionnaire
- Other drug use [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]Past two weeks other drug use according to the Timeline Follow-Back Questionnaire
- Psychotic symptoms [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]Total score on the Positive and Negative Syndrome Scale
- Severity of cannabis dependence [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]Total score on the Severity of Dependence Scale
- Social support [ Time Frame: Weeks -2-0 (baseline) ]Total score on the Social Provisions Scale
- Health service utilization [ Time Frame: Weeks -2-0 (baseline), 6, 12 and 18 ]Past month number of emergency visits and days of hospitalization confirmed by medical record abstraction
- Safety (adverse events) [ Time Frame: Weeks 6, 12 and 18 ]Adverse events and severe adverse events related or not to the study intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04968275
|Foothills Medical Centre Early Psychosis Intervention Program, Unit 24, 1403-29 Street NW|
|Calgary, Alberta, Canada, T2N 2T9|
|Canada, Nova Scotia|
|Nova Scotia Early Psychosis Program, 3rd Floor, Abbie Lane Bldg 5909 Veterans' Memorial Lane|
|Halifax, Nova Scotia, Canada, B3H 2E2|
|Clinic Connec-T - Institut universitaire en santé mentale de Montréal, 7401 rue Hochelaga|
|Montreal, Quebec, Canada, H1N 3M5|
|Clinique JAP, Centre hospitalier de l'Université de Montréal, 1051, rue Sanguinet|
|Montreal, Quebec, Canada, H2X 3E4|
|Clinic Notre-Dame des Victoires - Centre de Recherche CERVO, 2601 chemin de la Canardière|
|Québec, Quebec, Canada, G1J 2G3|
|Principal Investigator:||Didier Jutras-Aswad, MD, MSc||Centre hospitalier de l'Université de Montréal (CHUM)|