Telehealth-Plus-mHealth Intervention for Young Adults With Cannabis Use Disorder: Protocol for a Pilot Randomized Controlled Trial.

Background: More than 5 million young adults in the United States meet criteria for cannabis use disorder (CUD), placing them at risk for adverse physical, psychiatric, and social outcomes. Most individuals with CUD do not receive treatment due to numerous barriers, including motivation, stigma, limited availability and accessibility of developmentally appropriate services, and competing demands for time and finances. A novel digital health intervention, Momentary Self-Monitoring and Feedback + Motivational Enhancement Therapy-Virtual (MOMENT-V), was developed and combines telehealth motivational enhancement therapy with mobile health ecological momentary intervention (EMI) to provide a fully remote brief intervention for CUD among young adults. Objective: We describe the protocol for a parallel, 2-arm, pilot randomized controlled trial of MOMENT-V vs enhanced usual care (EUC) to evaluate intervention and trial feasibility in young adults with CUD recruited from primary care clinics. Methods: We are inviting primary care patients, aged 18 to 26 years, to self-screen through clinic posters with QR codes, invitations from clinicians, and patient portal messages. Eligible patients (eg, Cannabis Use Disorder Identification Test-Revised score ≥12, cannabis use ≥3 days/week, and smartphone ownership; N=60) will be randomly assigned 1:1 to receive MOMENT-V or EUC. MOMENT-V will include 2 weekly sessions of motivational enhancement therapy via telehealth, then 2 weeks of mobile health EMI-mobile self-monitoring with messages following reports of personal triggers for use. EUC will include a brief meeting with a counselor to review cannabis use problems and provide substance use and mental health resources. Participants will be assessed via surveys and a timeline followback calendar interview at baseline, 3 weeks, 3 months, and 6 months, and by an interview at 6 months. Primary outcomes will include completion, EMI engagement, and acceptability as measures of intervention feasibility, and screening, eligibility, enrollment, and retention rates as measures of trial feasibility. Primary outcomes will be evaluated against a priori benchmarks. Secondary outcomes will include counselor adherence to motivational interviewing principles, therapeutic alliance, duration of study activities, barriers, facilitators, CUD symptoms, and amount of delta-9-tetrahydrocannabinol used in standard units for motivation to change cannabis use, psychological distress, cognitive function, and quality of life. We will also examine cannabis use frequency and problems resulting from cannabis use. For the quantitative analyses, we will use descriptive statistics, logistic regression, and generalized linear mixed effects modeling. For the qualitative analyses, we will use immersion/crystallization, template organizing style, and thematic analysis. Results: Recruitment began in August 2025 and is anticipated to end in January 2027. Data collection is projected to be completed in July 2027. We plan to submit a manuscript describing the main outcomes in early 2028. Conclusions: This study will provide data regarding the MOMENT-V digital health intervention and trial feasibility in anticipation of a fully powered efficacy trial in young adults with CUD who are being seen in primary care.