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

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.

Conditions

• Depressive Disorder
• Anxiety Disorders

Interventions

BEHAVIORAL

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).

BEHAVIORAL

StayFine app-based monitoring

Monitoring six times per day for two weeks in the StayFine app.

Sponsors & Collaborators

• University of Groningen

  collaborator OTHER

• Amsterdam UMC, location AMC

  collaborator OTHER

• Accare

  collaborator OTHER

• RINO ZUID

  collaborator UNKNOWN

• Ggz Oost Brabant

  lead OTHER

Principal Investigators

• Yvonne Stikkelbroek, PhD · Ggz Oost Brabant

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-12-16

Primary Completion

2027-11-21

Completion

2027-11-21

Countries

• Netherlands

Study Locations