Therapeutic Mobile Applications for Youth with Psychosis

Centre hospitalier de I’Université de Montréal (CHUM)

Clinical Trial

Centre hospitalier de I’Université de Montréal (CHUM) is one of Canada’s leading academic research institutions, advancing clinical, public health, and addiction research.

Within CHUM, the Laboratoire de recherche Didier Jutras-Aswad conducts pioneering work on cannabis, mental health, and psychosis. The team partnered with Changemark to design and manage two national pilot trials—iCanChange (iCC) and CHAMPS—testing the feasibility of mobile interventions to reduce cannabis use and support harm reduction among young adults with early psychosis

Challenge

Cannabis use is common among youth with first-episode psychosis and is known to increase relapse risk, worsen symptoms, and hinder recovery. Despite strong evidence linking cannabis use to poorer outcomes, few interventions are designed specifically for this group — leaving significant gaps in access, engagement, and continuity of care. 

To address this, CHUM launched two pilot feasibility trials:

  • iCanChange (iCC): A mobile intervention based on cognitive behavioural therapy and motivational interviewing, designed to help youth reduce or quit cannabis use.

  • CHAMPS: A harm-reduction-focused e-intervention supporting participants to modify cannabis-related behaviours and manage use more safely.

Both studies aimed to test the feasibility and acceptability of digital interventions among youth aged 18–35 receiving early psychosis services. Each trial required coordinated project management at 6 sites across multiple provinces, standardized documentation, and effective recruitment of a hard-to-reach population. CHUM sought a partner with proven expertise in digital health trials, youth engagement, and cross-jurisdictional coordination to ensure rigorous, compliant, and timely execution.

Solution

Changemark delivered end-to-end project management and training for both trials, ensuring operational readiness, regulatory compliance, and high-quality implementation across all participating sites.

By embedding rigorous coordination with person-centered care principles, Changemark supported CHUM’s vision of making digital health research both credible and accessible. Our team ensured consistency across provinces, built strong communication channels between investigators, and maintained alignment with Good Clinical Practice (GCP) standards and Health Canada requirements—bridging scientific precision with seamless trial delivery.

The project included:

Project Management

  • Development and maintenance of Trial Master Files (TMF) and Investigator Site Files (ISF)

  • Coordination of Pre-Study Visits (PSVs) to confirm site preparedness before launch

  • Operational oversight for 5 clinical sites across Alberta, Québec, and Nova Scotia

  • Recruitment planning and milestone tracking to support timely activation and participant enrolment

  • Development of standardized workflows for participant screening, digital data capture, and remote monitoring

  • Continuous progress reporting and issue resolution to maintain consistency across trial teams

Training + Implementation Support

  • Design and delivery of customized Good Clinical Practice (GCP) and protocol-specific training for over 20 investigators and site staff

  • Creation of implementation manuals and checklists to support day-to-day study operations

  • Development of troubleshooting protocols for mobile platform functionality and data integrity

  • Ongoing communication and coaching to ensure strong engagement and study adherence

Results

The iCanChange and CHAMPS pilot trials were successfully completed in March 2025, achieving robust and unprecedented enrolment and high retention among youth with psychosis, a population traditionally difficult to engage in research.

See Publications

Impact Highlights:

  • 5 clinical sites activated across Alberta, Québec, and Nova Scotia

  • 20–30 investigators and research staff trained in digital health trial conduct

  • High participant engagement and retention rates

  • 3 peer-reviewed publications

  • 4 national and international conference presentations

  • Federal funding secured for a full-scale randomized controlled trial launching in 2025

Together, these pilots demonstrated that mobile interventions are feasible, acceptable, and effective tools for supporting harm reduction or abstinence among youth with psychosis, laying the groundwork for scalable, evidence-based digital health solutions. 

Interested in learning more?

Let’s talk about how we can help you design and manage digital health trials that translate innovation into real-world impact. 

Let’s Talk