NCT07811466

Brief Summary

Psychotic disorders affect approximately 4% of Canadians and have a significant impact on individuals' well-being, their families and social networks, and healthcare systems. The development of psychosis is explained by a complex interplay of genetic and environmental factors, including the use of psychoactive substances. Frequent cannabis use can contribute to the development of psychotic disorders. The prevalence of cannabis use disorder (CUD) in individuals with a first-episode psychosis (FEP) followed in Early Intervention Services (EIS) is 42-53%, well above that of the general population (\~3%). Cannabis use in individuals with psychosis is associated with increased symptom severity, higher rates of relapse and hospitalization, and poor psychosocial functioning. Standardized mobile app-based interventions offer a scalable and accessible solution. Our team developed and piloted CHAMPS (harm reduction) and iCanChange (use reduction/cessation) with favourable results: retention 82% (CHAMPS) and 84-86% (iCC), high satisfaction, and preliminary efficacy signals. The two pilot studies were targeting feasibility, this study is studying efficacy of the two app-based interventions (CHAMPS and iCanChange).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
55mo left

Started Sep 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Apr 2031

First Submitted

Initial submission to the registry

June 15, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2030

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2031

Last Updated

September 10, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

June 15, 2026

Last Update Submit

September 3, 2026

Conditions

Keywords

Adults 18-35 years old who had a first episode psychosis and are using cannabis

Outcome Measures

Primary Outcomes (2)

  • CHAMPS Primary Outcome Measure

    To determine whether adding CHAMPS (an intervention aimed at developing safer consumption behaviors) to standard EIS is superior to standard EIS alone in reducing cannabis-related problems in young adults with FEP who are not seeking to cease or reduce their use. Total score of the Marijuana Problems Scale (MPS, 19 items, 0-38) at Week 8 post-randomization (also assessed at Week 12 post-randomization). Minimum clinically important difference (MCID): 2 points. For each MPS item, the participant rates a cannabis-related problem over the past month on a three-point scale: 0 = not a problem, 1 = a minor problem, 2 = a serious problem. Total scores range from 0 to 38; higher scores indicate more serious problems.

    Week 8 post randomization

  • I Can Change Primary Outcome Measure

    To determine whether adding iCC to standard services offered in EIS clinics is superior to standard EIS alone in reducing the frequency of cannabis use in individuals with FEP and CUD (moderate to severe) who are seeking to reduce or cease their use. Number of days of cannabis use in the past 14 days (Timeline Follow Back, TLFB) at Week 12 (also assessed at Weeks 6 and 24 post-randomization).

    Week 12 post randomization

Secondary Outcomes (8)

  • CHAMPS secondary Outcome Measure

    week 0-8-12

  • CHAMPS secondary Outcome Measure

    week 0-8-12

  • CHAMPS secondary Outcome Measure

    week 0-8-12

  • CHAMPS secondary Outcome Measure

    week 0-8-12

  • I Can Change Secondary Outcome Measure

    Week 0-6-12-24

  • +3 more secondary outcomes

Study Arms (4)

CHAMPS - intervention group

EXPERIMENTAL

Participants who receive the CHAMPS intervention

Other: CHAMPS

CHAMPS - no intervention group

NO INTERVENTION

Participants who are not receiving the CHAMPS intervention and are compared to the one who do

I Can Change - Intervention group

EXPERIMENTAL

Participants who receive the I Can Change intervention

Other: I Can Change

I Can Change - No intervention group

NO INTERVENTION

Participants who are not receiving the I Can Change intervention and are compared to the one who do

Interventions

CHAMPSOTHER

CHAMPS is a psychosocial e-intervention grounded in motivational interviewing (MI) and harm reduction principles, developed using the Behavioral Change Wheel (BCW) theoretical framework. CHAMPS is delivered through a mobile health platform and comprises 6 sequential psychotherapeutic modules (5-15 minutes each) plus a booster session: Module 1: Automatic personalized feedback on current cannabis PBS based on baseline assessment, with improvement suggestions and identification of strengths that facilitate change. Module 2: Exploration of personal values and the potential benefits of safer cannabis use practices Module 3: Evidence-based cannabis PBS using interactive psychoeducational techniques Module 4: Goal-setting using the SMART technique; participants define their own realistic cannabis-focused goals Module 5: Review of goal progress; support to revise current goal or adopt new consumption habits Module 6: Reassessment of consumption habits (PBS)

CHAMPS - intervention group

iCanChange (iCC) is a mobile app-based psychological intervention that incorporates principles of CBT, MI, and psychoeducation. It is available on Android and iPhone, in both English and French. Section 1 (10 modules): Modules 1 to 9 address topics such as cannabis dependence, myths, and its effects on psychosis, while helping users identify personal triggers, strengths, and benefits of reducing use. Section 1 concludes with Module 10, in which participants self-identify a flexible, person-oriented cannabis use goal such as reducing or stopping use. Two weeks after Module 10, an additional module is offered (up to two times) to consolidate and review goals. Section 2 (8 modules): Modules aim at increasing coping skills, equipping users with practical tools to maintain progress, planning cannabis-free activities, building social support, managing stress, and adopting a healthy lifestyle. Booster modules (3 sessions, one per month during the 12-week follow-up)

I Can Change - Intervention group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • CHAMPS INTERVENTION
  • Young adults (18-35 years) with FEP
  • Cannabis use ≥1 day in the past month
  • MPS score ≥2,
  • NOT seeking treatment for cannabis use disorder (CUD).
  • CUD diagnosis possible but not required.
  • With a minimum of 2 months of follow-up at an EIS clinic.
  • I CAN CHANGE INTERVENTION
  • Young adults (18-35 years) with FEP and CUD (DSM-5, moderate to severe)
  • Seeking to reduce or cease use
  • With a minimum of 2 months of follow-up at an EIS clinic.

You may not qualify if:

  • Pregnancy, breastfeeding, or any medical condition that, in the opinion of the psychiatrist, precludes safe participation or the ability to provide informed consent,
  • Any disabling, unstable, or acute mental condition that, in the opinion of the psychiatrist, precludes safe participation or the ability to provide informed consent,
  • Any planned extended absence (pending legal action, surgery, inpatient program) or other reason that, in the opinion of the study team, might prevent completion of the study,
  • Presence of a substance use disorder that, in the opinion of the psychiatrist, precludes safe participation (e.g., very unstable or severe SUD),
  • Currently participating in another specific cannabis use-focused intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (46)

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MeSH Terms

Conditions

Psychotic DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Didier Jutras-Aswad, MD

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The app-based interventions are added to the services offered in EIS. Participants will be randomized in the intervention group (with the app-based intervention in addition to the regular follow-up in EIS clinic) or the standard EIS clinic group alone)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2026

First Posted

September 10, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

September 15, 2030

Study Completion (Estimated)

April 15, 2031

Last Updated

September 10, 2026

Record last verified: 2026-06