SHADE-Predict: A Pilot Study Exploring Genetic and Digital Predictors of Treatment Response to an eHealth Intervention for Alcohol Use in Adults with Moderate to Hazardous Drinking

The intervention evaluated in this study is the "Self-Help for Alcohol and Depression (SHADE)" program, an evidence-based online intervention for individuals experiencing problematic alcohol use and depressed mood. SHADE comprises of 10 treatment modules that include educational content, interactive exercises, and case vignettes, and is based on Cognitive Behaviour Therapy (CBT), Motivational Enhancement Therapy (MET)/motivational interviewing techniques, and mindfulness-based stress reduction approaches. Participants are encouraged to work through the program independently as a self-help intervention. The intervention is delivered primarily by the "SHADE", with additional support provided by members of the research team through regular check-in calls. The protocol identifies research staff, including the Research Assistant responsible for coordinating study activities and conducting follow-up calls, with support from other investigators who provide clinical supervision and assistance with participant contact and technical issues. The intervention itself was developed by Professor Frances Kay and is based on established evidence-based psychological treatments for alcohol use problems. SHADE is delivered online via the internet and can be accessed using a computer or smartphone. It is designed as an individual, self-guided intervention rather than a group-based treatment. Participants are introduced to the program during an in-person baseline appointment and then access the modules remotely throughout the study period. Participants are granted access to SHADE for 12 weeks (approximately three months). The program contains 10 modules that are designed to be completed at a rate of one module per week. In addition, participants receive fortnightly check-in calls from a member of the research team between weeks 3 and 12 to discuss progress in the program and address any questions or concerns. The intervention is delivered primarily online in participants’ own environments, wherever they can access the internet. However, participants first attend an in-person baseline assessment at the Hunter Medical Research Institute (HMRI) at week 1 of the study, where they complete study procedures and are set up with the SHADE program and other digital study tools. Adherence is supported through several strategies. Participants receive fortnightly telephone check-in calls, with SMS reminder messages sent the day before each scheduled call. The study also uses assertive follow-up procedures, including phone calls, text messages, emails, appointment confirmations, and contact with alternate contacts when necessary to encourage retention. Adherence and engagement are monitored through measures such as the number of SHADE logins, number of SHADE modules completed, number of iYarn check-ins completed, and the percentage of days with smartwatch data available.