JMIR Publications

ABSTRACT

Background:

Cannabis use is most prevalent among adolescents and young adults, and frequent consumption is associated with cannabis use disorder (CUD) and psychosis, with a high prevalence (up to 50%) of CUD in individuals with first episode psychosis (FEP). Early Intervention Services (EIS) for psychosis include face-to-face psychosocial interventions for CUD because reducing or discontinuing cannabis use improves clinical and healthcare service use outcomes. However, multiple barriers (e.g., staff availability, limited access to treatment) can hinder the implementation of these interventions. Mobile health (mHealth) interventions may help circumvent some of these barriers, but to date no study has evaluated the effects of mHealth psychological interventions for CUD in individuals with FEP.

Objective:

This manuscript describes the protocol for a pilot randomized controlled trial (RCT) using a novel mHealth psychological intervention (iCanChange, iCC) to address CUD in young adults with FEP. The iCC was developed based on clinical evidence showing that in individuals without psychosis, integrating principles of cognitive behavioral therapy (CBT), motivational interviewing (MI), and behavioural self-management approaches are effective in improving cannabis use-related outcomes.

Methods:

Consenting individuals (N=100) meeting inclusion criteria (e.g., 18 to 35 years with FEP and CUD) will be randomly allocated in a 1:1 ratio to the intervention (iCC + modified EIS) or the control (EIS) group. The iCC is fully automatized and contains 21 modules that are completed over a 12-weeks period and three booster modules available during the 3-months follow-up period. Validated self-report measures will be taken via in-person assessments at baseline and 6, 12 (endpoint), and 24 weeks (end of trial); iCC utilization data will be collected directly from the mobile application. Primary outcomes are intervention completion and trial retention rates, and secondary outcomes are cannabis use quantity, participant satisfaction, application usage, and trial recruiting parameters. Exploratory outcomes (e.g., severity of psychotic symptoms, CUD severity) will contribute to a better understanding of the benefits of using iCC in clinical settings. For primary outcomes, we will use the Chi-square test using data collected at week 12. We will consider participation in iCC acceptable if more than 50% of participants complete at least 11 out of 21 intervention modules and the trial feasible if attrition does not reach 50%. We will use ANCOVA (e.g., quantity of cannabis use) and mixed-effects models (e.g., participant satisfaction) for secondary outcomes and generalized estimating equation multivariable analyses for exploratory outcomes.

Results:

Recruitment started in July 2022 and data collection is anticipated to be completed by April 2024. The main results are expected to be submitted for publication in 2024.

Conclusions:

If feasible, the study will provide essential data for a larger-scale efficacy trial of iCC on cannabis use outcomes in individuals with FEP and CUD. Clinical Trial: ClinicalTrials.gov NCT05310981; https://clinicaltrials.gov/ct2/show/NCT05310981