StayFine: Personalised Relapse Prevention of Anxiety and Mood Disorders in Youths

The current study examines the effectiveness of the StayFine app for relapse prevention of anxiety or depressive disorders in youth using a randomized controlled trial. In addition, ecological momentary assessment (EMA) is used to explore fluctuations in emotions, psychological factors as predictor of the intervention effect and potential differential mechanisms of change. A total of 254 healthy youths remitted from an anxiety and/or depressive disorder, aged 13-21 years old, will be recruited for the study. Participants will be randomized to either 1) use the StayFine app exclusively for monitoring, or 2) use the StayFine app for monitoring and interventions supported by an expert patient. Stratification blocks are of random size and depend on previous episodes (1/2/3 or more) and previous treatment (yes/no). The intervention is based on the well-established Preventive Cognitive Therapy (PCT) for relapse prevention for adults and Cognitive Behavioral therapy adapted for the relapse prevention phase, both supplemented for anxiety and adolescents. In both conditions adolescents monitor their symptoms five times in three years and feedback and treatment advice is given in case of relapse. The primary outcome will be time to relapse. Secondary outcomes are (core) symptoms of depression and anxiety, number and duration of relapses, global functioning and quality of life. Mediators and moderators will be explored. Exploratory endpoints are monitoring and wearable outcomes.

NCT Number	NCT05551468
Lead Sponsor	Ggz Oost Brabant Collaborators: University of Groningen, Amsterdam UMC, location AMC, Accare, RINO ZUID
Conditions	Depressive Disorder, Anxiety Disorders
Enrollment	254 participants
Start Date	2019-12-16
Primary Completion	2027-11-21 (estimated)
Study Completion	2027-11-21 (estimated)
Updated on ClinicalTrials.gov	2024-12-05