Dependence Addictive, First Episode Psychosis (FEP), Psychosis, Schizophreni-form Disorder
Conditions
Keywords
Adults 18-35 years old who had a first episode psychosis and are using cannabis
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).
Interventions
OTHERCHAMPS
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)
OTHERI Can Change
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)
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Integrated University Health and Social Services Center of the Capitale-Nationale
Nova Scotia Health Authority
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CHAMPS Primary Outcome Measure | 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. |
| I Can Change Primary Outcome Measure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CHAMPS secondary Outcome Measure | 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. |
| I Can Change Secondary Outcome Measure | 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). |
Contacts
CONTACTCatherine Provost, LL. M.
CONTACTPamela Lachance-Touchette, PhD
PRINCIPAL_INVESTIGATORDidier Jutras-Aswad, MD
Centre hospitalier de l'Université de Montréal (CHUM)
Outcome results
None listed