Digital relapse prevention plan for substance use disorders: study protocol for a multicentre randomised controlled trial.

Abstract

<b>Introduction</b>Relapse remains a major challenge in the treatment of substance use disorders (SUDs), particularly during follow-up. Digital tools are emerging as supportive resources, but few deliver real-time interventions. This study will examine the effectiveness of a digital relapse prevention plan (DRPP) integrated into a certified mobile application to detect early risk signs and provide immediate, personalised responses.<b>Methods and analysis</b>A multicentre randomised controlled trial will recruit adults with SUD. Participants will be randomised to standard treatment plus a restricted app version (control) or the same treatment with the full app, including automated alerts and DRPP access (experimental). The plan can be activated manually or automatically through smartphone sensors detecting risk patterns. The primary outcome will be time to first clinical relapse, while secondary outcomes will include patient satisfaction with the DRPP, adherence and perceived emotional self-regulation. Findings are expected to provide robust evidence on the feasibility, acceptability and clinical utility of digital relapse prevention strategies.<b>Ethics and dissemination</b>This study obtained ethical approval (code 25/327) from Committee of Hospital Universitario 12 de Octubre.<b>Trial registration number:</b>NCT07052175.