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StayFine: Personalised Relapse Prevention of Anxiety and Mood Disorders in Youths
Sponsor: Ggz Oost Brabant
Summary
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.
Official title: StayFine: a Personalized Monitoring and Intervention App to Prevent Relapse of Anxiety and Mood Disorders in Youth and Young Adults
Key Details
Gender
All
Age Range
13 Years - 21 Years
Study Type
INTERVENTIONAL
Enrollment
254
Start Date
2019-12-16
Completion Date
2027-11-21
Last Updated
2024-12-05
Healthy Volunteers
Yes
Conditions
Interventions
StayFine guided app-based personalised intervention modules
Participants work on guided app-based personalised intervention modules in the StayFine app over the course of three months. The modules are selected by the participant based on shared decision making and a personalized advice. The intervention is based on Preventive Cognitive Therapy (PCT) with elements of Cognitive Behavioral Therapy (CBT) and Positive Psychology. Modules are: psycho education (mandatory), cognitive restructuring (mandatory), positive affect, behavioral activation, exposure, wellness, sleep and a relapse prevention plan (mandatory).
StayFine app-based monitoring
Monitoring six times per day for two weeks in the StayFine app.
Locations (1)
GGZ Oost Brabant
Boekel, Netherlands