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First Episode Psychosis (FEP)Mobile HealthNCT07811466

Mobile Application-Based Interventions for Cannabis Use in Young Adults With First Episode Psychosis

A study testing CHAMPS and I Can Change in people with First Episode Psychosis (FEP) and Psychosis, run by Centre hospitalier de l'Université de Montréal (CHUM).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years
What is being tested?
CHAMPS and I Can Change
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
No sites listed yet
Study dates
15 Sep 2026to 15 Apr 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Catherine Provost, LL. M. contact

514-890-800- ext. 30833

catherine.provost.chum@ssss.gouv.qc.ca

Pamela Lachance-Touchette, PhD contact

514-890-8000

pamela.lachance-touchette.chum@ssss.gouv.qc.ca

About this study

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).

Being tested
CHAMPS, I Can Change
Keywords
Adults 18-35 years old who had a first episode psychosis and are using cannabis
Medical subject headings
Psychotic Disorders, Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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)

  • I Can ChangeOther

    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)

Study groups in NCT07811466
Study groupRoleWhat they receive
CHAMPS - intervention groupExperimentalParticipants who receive the CHAMPS intervention
Receives: Other: CHAMPS
CHAMPS - no intervention groupNo interventionParticipants who are not receiving the CHAMPS intervention and are compared to the one who do
I Can Change - Intervention groupExperimentalParticipants who receive the I Can Change intervention
Receives: Other: I Can Change
I Can Change - No intervention groupNo interventionParticipants who are not receiving the I Can Change intervention and are compared to the one who do

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 8 post randomization

  2. 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).

    Measured: Week 12 post randomization

Secondary outcomes (8)

  1. CHAMPS secondary Outcome Measure

    Number of days of cannabis use in the past 14 days - Timeline Follow Back (TFLB) The TLFB will assess self-reported days of cannabis use over the past 14 days , as well as type of cannabis products, provenance, form, and quantity . The main endpoint for this outcome is the number of days per week of cannabis use. Days per week is the preferred manner of reporting cannabis use frequency in the field, and use of cannabis once per week or more is an established threshold for increased risk of adverse psychosis-related outcomes.

    Measured: week 0-8-12

  2. CHAMPS secondary Outcome Measure

    Protective behavioral strategies: PBSM total score (17 items, 15-73) The PBSM is a 17-item, self-report measure including various evidence-based strategies that cannabis users can adopt to reduce harms or use more safely. For each item, participants rate the degree to which they engage in a specific protective behavior on a scale of 1 = Never to 6 = Always. Individual item responses are summed for a total score, which is then converted to an item-response theory scaled score (possible range: 15-73). Higher scaled scores indicate greater use of PBS.

    Measured: week 0-8-12

  3. CHAMPS secondary Outcome Measure

    The proportion of participants in each State of Change Designation (i.e., precontemplation, contemplation, and action) Readiness to change Questionnaire (RCQ) Motivation to change cannabis use practices will be assessed using the adapted 12-item Readiness-to-Change Questionnaire (RCQ), modified for cannabis use. The RCQ is based on Prochaska and DiClemente's stages-of-change model and assesses three stages: pre-contemplation, contemplation, and action. For each scale, 4 items are summed (range: -8 to +8); the scale with the highest score represents the participant's Stage of Change Designation. The internal consistency of the three subscales is acceptable. The tool is designed for cannabis users not seeking treatment who may be unaware of a problem.

    Measured: week 0-8-12

  4. CHAMPS secondary Outcome Measure

    Quality of life: WHOQOL-BREF (26 items, 4 domains, 0-100) Quality of life will be measured using the WHOQOL-BREF, which assesses four domains: physical health, psychological health, social relationships, and environment, plus two overall items. The WHOQOL-BREF consists of 26 items; each item is rated on a 5-point Likert scale ranging from very poor to very good. Domain scores are calculated according to WHOQOL-BREF guidelines and converted to a 0-100 scale; an overall total score will also be calculated .

    Measured: week 0-8-12

  5. I Can Change Secondary Outcome Measure

    Cannabis dependence severity will be assessed using the Severity of Dependence Scale (SDS), a 5-item self-report questionnaire validated in people with early psychosis. Items are scored 0-3; total scores range from 0-15 (higher = greater dependence severity).

    Measured: Week 0-6-12-24

  6. I Can Change Secondary Outcome Measure

    Motivation to reduce cannabis use will be assessed using the Precaution Adoption Process Model (PAPM), a theoretical stage-based model that classifies individuals into 6 nominal stages: (1) unaware, (2) unengaged, (3) undecided, (4) decided not to act, (5) decided to act, (6) acting. Stages will be dichotomized for inter-group comparison (e.g., pre-action vs. action stages).

    Measured: Week 0-6-12-24

  7. I Can Change Secondary Outcome Measure

    In addition to frequency (primary endpoint), the timeline follow back (TLFB) will capture continuous abstinence (proportion of participants with 0 days of cannabis use in past 14 days) and estimated quantity of cannabis used per session.

    Measured: Week 0-6-12-24

  8. I Can Change Secondary Outcome Measure

    Quality of life will be measured using the WHOQOL-BREF, which has been validated in individuals with psychotic disorders and consists of 26 items across 4 domains: physical health, psychological health, social relationships, and environment. Each item is rated on a 5-point Likert scale ranging from very poor to very good. For each domain, scores are calculated according to WHOQOL-BREF guidelines and converted to a 0-100 scale.

    Measured: Week 0-6-12-24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion15 Sep 2030 (estimated)
  4. Study completion15 Apr 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
None (open label)
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07811466
Sponsor's protocol ID
MP-02-2026-13381
Acronym
Mobile Health
Status last verified
Jun 2026
First submitted
15 Jun 2026
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Research personnel will inform participants that all information collected will remain strictly confidential to the extent prescribed by law, and that no individually identifiable information will be revealed in any publication or presentation. Only authorized persons having an authentication code and designated data access group have access to the REDCap databases. Protection, detection and correction measures are implemented to maintain data confidential. A potential breach of confidentiality, notably regarding substance use, could conceivably result in negative legal or social consequences.

Publications

  • Yardley L, Morrison L, Bradbury K, Muller I. The person-based approach to intervention development: application to digital health-related behavior change interventions. J Med Internet Res. 2015 Jan 30;17(1):e30. doi: 10.2196/jmir.4055.

    PubMed 25639757

  • World Health, O. (1996). WHOQOL-BREF: Introduction, administration, scoring and generic version of the assessment. World Health Organization.

  • Tossmann HP, Jonas B, Tensil MD, Lang P, Struber E. A controlled trial of an internet-based intervention program for cannabis users. Cyberpsychol Behav Soc Netw. 2011 Nov;14(11):673-9. doi: 10.1089/cyber.2010.0506. Epub 2011 Jun 8.

    PubMed 21651419

  • Tatar O, Bastien G, Abdel-Baki A, Huynh C, Jutras-Aswad D. A systematic review of technology-based psychotherapeutic interventions for decreasing cannabis use in patients with psychosis. Psychiatry Res. 2020 Jun;288:112940. doi: 10.1016/j.psychres.2020.112940. Epub 2020 Apr 15.

    PubMed 32344316

  • 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.

    PubMed 36427227

  • Tatar O, Abdel-Baki A, Tra C, Mongeau-Perusse V, Arruda N, Kaur N, Landry V, Coronado-Montoya S, Jutras-Aswad D. Technology-Based Psychological Interventions for Young Adults With Early Psychosis and Cannabis Use Disorder: Qualitative Study of Patient and Clinician Perspectives. JMIR Form Res. 2021 Apr 5;5(4):e26562. doi: 10.2196/26562.

    PubMed 33818397

  • Tatar O, Abdel-Baki A, Dyachenko A, Bakouni H, Bahremand A, Tibbo PG, Crockford D, Roy MA, Copeland J, Fischer B, Lecomte T, Cote J, Ouellet-Plamondon C, L'Heureux S, Villeneuve M, Jutras-Aswad D. Evaluating preferences for online psychological interventions to decrease cannabis use in young adults with psychosis: An observational study. Psychiatry Res. 2023 Aug;326:115276. doi: 10.1016/j.psychres.2023.115276. Epub 2023 May 30.

    PubMed 37301021

  • Tatar, O, Abdel, B., A, Côté, J, Lachance, T., P, Crocker, C, E., Roy, M, A., Jutras, A., & D. (2021). Patient and clinician preferences for a smartphone-based intervention for cannabis use in early psychosis. Early Intervention in Psychiatry, 16(1), 49-58.

  • Sobell, L. C., & Sobell, M. B. (1996). Timeline Followback user's guide: A calendar method for assessing alcohol and drug use. Addiction Research Foundation.

  • Rooke S, Copeland J, Norberg M, Hine D, McCambridge J. Effectiveness of a self-guided web-based cannabis treatment program: randomized controlled trial. J Med Internet Res. 2013 Feb 15;15(2):e26. doi: 10.2196/jmir.2256.

    PubMed 23470329

  • Robinson T, Ali MU, Easterbrook B, Coronado-Montoya S, Daldegan-Bueno D, Hall W, Jutras-Aswad D, Fischer B. Identifying risk-thresholds for the association between frequency of cannabis use and development of cannabis use disorder: A systematic review and meta-analysis. Drug Alcohol Depend. 2022 Sep 1;238:109582. doi: 10.1016/j.drugalcdep.2022.109582. Epub 2022 Jul 21.

    PubMed 35932748

  • Pennou A, Lecomte T, Potvin S, Khazaal Y. Mobile Intervention for Individuals With Psychosis, Dual Disorders, and Their Common Comorbidities: A Literature Review. Front Psychiatry. 2019 May 3;10:302. doi: 10.3389/fpsyt.2019.00302. eCollection 2019.

    PubMed 31130884

  • Pedersen ER, Huang W, Dvorak RD, Prince MA, Hummer JF; (The Marijuana Outcomes Study Team). The Protective Behavioral Strategies for Marijuana Scale: Further examination using item response theory. Psychol Addict Behav. 2017 Aug;31(5):548-559. doi: 10.1037/adb0000271. Epub 2017 Jul 13.

    PubMed 28703616

  • Nolin M, Malla A, Tibbo P, Norman R, Abdel-Baki A. Early Intervention for Psychosis in Canada: What Is the State of Affairs? Can J Psychiatry. 2016 Mar;61(3):186-94. doi: 10.1177/0706743716632516.

    PubMed 27254094

  • Musiat P, Johnson C, Atkinson M, Wilksch S, Wade T. Impact of guidance on intervention adherence in computerised interventions for mental health problems: a meta-analysis. Psychol Med. 2022 Jan;52(2):229-240. doi: 10.1017/S0033291721004621. Epub 2021 Nov 22.

    PubMed 34802474

Questions about this trial

What is this clinical trial studying?

A study testing CHAMPS and I Can Change in people with First Episode Psychosis (FEP) and Psychosis, run by Centre hospitalier de l'Université de Montréal (CHUM).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Catherine Provost, LL. M. (514-890-800- ext. 30833, catherine.provost.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CHAMPS Primary Outcome Measure (time frame: Week 8 post randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07811466, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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