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

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).

연구 개요

연구 유형

중재적

등록 (추정된)

550

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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)

간섭 없음: CHAMPS - no intervention group
Participants who are not receiving the CHAMPS intervention and are compared to the one who do
실험적: 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)

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
CHAMPS Primary Outcome Measure
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
CHAMPS secondary Outcome Measure
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 15일

기본 완료 (추정된)

2030년 9월 15일

연구 완료 (추정된)

2031년 4월 15일

연구 등록 날짜

최초 제출

2026년 6월 15일

QC 기준을 충족하는 최초 제출

2026년 9월 3일

처음 게시됨 (실제)

2026년 9월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 3일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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