Background Cannabis use is the most prevalent among adolescents and young adults; 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 health care service use outcomes. However, multiple barriers (eg, staff availability and limited access to treatment) can hinder the implementation of these interventions. Mobile health (mHealth) interventions may help circumvent some of these barriers; however, to date, no study has evaluated the effects of mHealth psychological interventions for CUD in individuals with FEP. Objective This study describes the protocol for a pilot randomized controlled trial using a novel mHealth psychological intervention (iCanChange [iCC]) to address CUD in young adults with FEP. iCC was developed based on clinical evidence showing that in individuals without psychosis, integrating the principles of cognitive behavioral therapy, motivational interviewing, and behavioral self-management approaches are effective in improving cannabis use–related outcomes. Methods Consenting individuals (n=100) meeting the inclusion criteria (eg, aged 18-35 years with FEP and CUD) will be randomly allocated in a 1:1 ratio to the intervention (iCC+modified EIS) or control (EIS) group. The iCC is fully automatized and contains 21 modules that are completed over a 12-week period and 3 booster modules available during the 3-month follow-up period. Validated self-report measures will be taken via in-person assessments at baseline and at 6, 12 (end point), and 24 weeks (end of trial); iCC use data will be collected directly from the mobile app. Primary outcomes are intervention completion and trial retention rates, and secondary outcomes are cannabis use quantity, participant satisfaction, app use, and trial recruiting parameters. Exploratory outcomes include severity of psychotic symptoms and CUD severity. For primary outcomes, we will use the chi-square test using data collected at week 12. We will consider participation in iCC acceptable if ≥50% of the participants complete at least 11 out of 21 intervention modules and the trial feasible if attrition does not reach 50%. We will use analysis of covariance and mixed-effects models for secondary outcomes and generalized estimating equation multivariable analyses for exploratory outcomes. Results Recruitment began in July 2022, and data collection is anticipated to be completed in July 2024. The main results are expected to be submitted for publication in 2024. We will engage patient partners and other stakeholders in creating a multifaceted knowledge translation plan to reach a diverse audience. Conclusions If feasible, this study will provide essential data for a larger-scale efficacy trial of iCC on cannabis use outcomes in individuals with FEP and CUD. Trial Registration ClinicalTrials.gov NCT05310981; https://www.clinicaltrials.gov/ct2/show/NCT05310981 International Registered Report Identifier (IRRID) PRR1-10.2196/40817
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. CLINICALTRIAL ClinicalTrials.gov NCT05310981; https://clinicaltrials.gov/ct2/show/NCT05310981
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