A Cannabis E-intervention for Young Cannabis Users With Early Psychosis (iCC)

NCT05310981 | Completed DMC

• 1 other identifier: 21.310
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

The concerning lack of research related to technology-based psychological interventions in individuals with psychosis and cannabis use disorder (CUD) led to the design a randomized control trial (RCT) with an innovative mobile health e-intervention called ICanChange (iCC). Randomized control trials (RCTs) on well-defined samples (limited to psychosis and CUD) are needed to generate evidence on e-health interventions in individuals with psychosis and CUD. As such, an RCT will be conducted to assess the acceptability and feasibility of administering this e-intervention to young people with psychosis who use cannabis. Besides having scarce cannabis interventions adapted for people with psychosis, there are other barriers to addressing problematic cannabis use, such as the challenging and inadequate access to mental health and substance use services by this population. Implementing these and other approaches in the context of a harm reduction intervention or applying other strategies seeking to minimize cannabis-related harms for people who wish to continue using cannabis may be key in helping individuals set realistic goals that are important and relevant to them.

Conditions

Cannabis Use Disorder

Outcome Measures

Primary Outcomes (2)

• Completion rates

  Number of participants who completed the first section of the intervention and at least one module from section 2 related to achieving their cannabis consumption objectives or with ongoing participation in EIS.

  Week 12

• Retention rates

  Proportions of participants retained in the trial (completing all endpoint assessments)

  Week 12

Secondary Outcomes (4)

• Acceptability (iCC usage data)

  Weeks 0-24

• Participant satisfaction

  Weeks 6, 12 & 24

• Trial parameters

  Week -4 to Week 24

• Cannabis Use

  (-2-0 (baseline) and Week 6, 12 & 24

Other Outcomes (11)

• Psychotic Symptoms

  (-2-0 (baseline) and Week 6, 12 & 24

• Cannabis-related problems

  (-2-0 (baseline) and Week 6, 12 & 24

• Cannabis use frequency and abstinence

  (-2-0 (baseline) and Week 6, 12 & 24

Study Arms (2)

Experimental: CHAMPS and mEIS

EXPERIMENTAL

Brief mobile application-based psychological intervention based on the principles of motivational interviewing (MI) and cognitive behavioural therapy (CBT). This e-intervention will be completed by the participant using a smart phone. There will be up to a maximum of 24 individual sessions (which includes 3 booster sessions) each lasting approximately 10-15 minutes. mEIS: iCC will be administered adjunctively to modified EIS (mEIS), which will include all interventions usually provided through EIS except for any specific psychological interventions (MI, CBT, contingency management) for CUD.

Behavioral: iCanChange

No Intervention: EIS alone

NO INTERVENTION

Early intervention services will be offered as per standard of care following EIS for psychosis and CUD guidelines, at participating clinical sites. Any visits and services offered in control arm will be considered 'usual care' and administered either through in-person clinic visits, community visits, phone calls, or video calls. Relevant service information will be collected for study purposes.

Interventions

iCanChange BEHAVIORAL

iCC is a psychological app based intervention that will be delivered in form of up to 24 brief (10-15 minutes) interactive modules developed based on the principles of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). During the intervention, participants will be offered MI and CBT-based activities (i.e., modules and strategies) aiming at facilitating change in cannabis use. At any point during the intervention, participants can reference modules that had been completed. Due to the frequency of behavioral stage changes in this population (e.g., regression in behavioral stage of change), stage of change will be monitored regularly throughout the intervention. During the follow-up period (i.e., Week 12-24), participants will have continuous access to the smart phone application and all built-in add-ons as described above. During this period, they will have access to 3 booster session.

Experimental: CHAMPS and mEIS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria:
• Young adults age 18 to 35 years old
• 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
• Diagnosed with a current CUD (any severity), based on Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
• Currently using cannabis (used cannabis at least once in the past month)
• Accepting an intervention for CUD to cease or decrease his/her use
• Able to provide full informed consent
• Available for the whole duration of the study/able to comply with study procedures
• Able to comprehend French or English

You may not qualify if:

• 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 an additional 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 participating in another specific cannabis use-focused intervention (other than those which are part of the intervention and control arms)

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Ministere de la Sante et des Services Sociaux: collaborator

Study Sites (5)

Foothills Medical Centre Early Psychosis Intervention Program

Calgary, Alberta, T2N2T9, Canada

Location

Nova Scotia Early Psychosis Program

Halifax, Nova Scotia, B3H2E2, Canada

Location

Clinic Connec-T - Institut universitaire en santé mentale de Montréal

Montreal, Quebec, H1N3M5, Canada

Location

Clinique JAP, Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location

Clinic Notre-Dame des Victoires - Centre de Recherche CERVO

Québec, Quebec, G1J2G3, Canada

Location

Related Publications (1)

• Tatar O, Abdel-Baki A, Wittevrongel A, Lecomte T, Copeland J, Lachance-Touchette P, Coronado-Montoya S, Cote J, Crockford D, Dubreucq S, L'Heureux S, Ouellet-Plamondon C, Roy MA, Tibbo PG, Villeneuve M, Jutras-Aswad D. Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC). JMIR Res Protoc. 2022 Nov 25;11(11):e40817. doi: 10.2196/40817.

  PMID: 36427227 DERIVED

Study Officials

• Didier Jutras-Aswad, MD, MSc

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two-arm parallel, open-labelled, pilot randomized controlled trial

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: April 5, 2022
• Study Start: July 6, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 12 months following the study completion.
• Access Criteria: On request.

Locations

CA (5)