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

3 września 2026 zaktualizowane przez: Centre hospitalier de l'Université de Montréal (CHUM)

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).

Przegląd badań

Typ studiów

Interwencyjne

Zapisy (Szacowany)

550

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: CHAMPS - intervention group
Participants who receive the CHAMPS intervention

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)

Brak interwencji: CHAMPS - no intervention group
Participants who are not receiving the CHAMPS intervention and are compared to the one who do
Eksperymentalny: I Can Change - Intervention group
Participants who receive the I Can Change intervention

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)

Brak interwencji: I Can Change - No intervention group
Participants who are not receiving the I Can Change intervention and are compared to the one who do

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
CHAMPS Primary Outcome Measure
Ramy czasowe: Week 8 post randomization
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
Ramy czasowe: Week 12 post randomization
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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
CHAMPS secondary Outcome Measure
Ramy czasowe: week 0-8-12
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.
week 0-8-12
CHAMPS secondary Outcome Measure
Ramy czasowe: week 0-8-12
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.
week 0-8-12
CHAMPS secondary Outcome Measure
Ramy czasowe: week 0-8-12
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.
week 0-8-12
CHAMPS secondary Outcome Measure
Ramy czasowe: week 0-8-12
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 .
week 0-8-12
I Can Change Secondary Outcome Measure
Ramy czasowe: Week 0-6-12-24
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).
Week 0-6-12-24
I Can Change Secondary Outcome Measure
Ramy czasowe: Week 0-6-12-24
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).
Week 0-6-12-24
I Can Change Secondary Outcome Measure
Ramy czasowe: Week 0-6-12-24
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.
Week 0-6-12-24
I Can Change Secondary Outcome Measure
Ramy czasowe: Week 0-6-12-24
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.
Week 0-6-12-24

Współpracownicy i badacze

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Publikacje i pomocne linki

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 września 2026

Zakończenie podstawowe (Szacowany)

15 września 2030

Ukończenie studiów (Szacowany)

15 kwietnia 2031

Daty rejestracji na studia

Pierwszy przesłany

15 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 września 2026

Pierwszy wysłany (Rzeczywisty)

10 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 września 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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