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

Last updated: May 14, 2024
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Substance Abuse

Treatment

iCanChange

Clinical Study ID

NCT05310981
21.310
  • Ages 18-35
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants must meet all of the following criteria:

  1. Young adults age 18 to 35 years old

  2. Diagnosed with any psychotic disorder, which can include schizophrenia,schizoaffective disorder, bipolar disorder with psychotic features, delusionaldisorder, psychotic disorder not otherwise specified, brief psychotic disorder andsubstance-induced psychotic disorder.

  3. Has been followed at an early psychosis clinic for a minimum of 3 months

  4. Diagnosed with a current CUD (any severity), based on Diagnostic and StatisticalManual of Mental Disorders (DSM)-5 criteria

  5. Currently using cannabis (used cannabis at least once in the past month)

  6. Accepting an intervention for CUD to cease or decrease his/her use

  7. Able to provide full informed consent

  8. Available for the whole duration of the study/able to comply with study procedures

  9. Able to comprehend French or English

Exclusion

Exclusion Criteria:

  1. Any medical condition that in the opinion of the psychiatrist precludes safeparticipation in the study or the ability to provide fully informed consent

  2. Any disabling, unstable or acute mental condition that in the opinion of thepsychiatrist precludes safe participation in the study or the ability to providefully informed consent

  3. Any legal/judicial status/issue, pending legal action, or other reasons in theopinion of the study team that might prevent completion of the study

  4. Presence of an additional substance use disorder that, in the opinion of thepsychiatrist, precludes safe participation in the study (e.g., very unstable orsevere substance use disorder)

  5. Currently participating in another specific cannabis use-focused intervention (otherthan those which are part of the intervention and control arms)

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: iCanChange
Phase:
Study Start date:
July 06, 2022
Estimated Completion Date:
July 31, 2024

Study Description

This is a multi-site, two-arm, open-label, pilot randomized control trial, involving 100 young adults diagnosed with psychosis and cannabis use disorder (CUD). Participants will be randomly assigned to either:

Arm 1. Early intervention services (EIS): early intervention for psychosis, including standard of care for psychosis and CUD following Canadian guidelines.

Arm 2. iCC + modified EIS (mEIS): The iCC is an application-based intervention that includes psychotherapeutic modules based on Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT). Participants in this arm also receive the same services as in EIS, excluding formal psychotherapeutic interventions for CUD.

Participants will complete assessments at baseline, and at 6, 12, and 24 weeks from baseline.

Connect with a study center

  • Foothills Medical Centre Early Psychosis Intervention Program

    Calgary, Alberta T2N2T9
    Canada

    Site Not Available

  • Nova Scotia Early Psychosis Program

    Halifax, Nova Scotia B3H2E2
    Canada

    Site Not Available

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

    Montréal, Quebec H1N3M5
    Canada

    Site Not Available

  • Clinique JAP, Centre hospitalier de l'Université de Montréal

    Montréal, Quebec H2X 3E4
    Canada

    Site Not Available

  • Clinic Notre-Dame des Victoires - Centre de Recherche CERVO

    Québec, Quebec G1J2G3
    Canada

    Site Not Available

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