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

NCT05551468 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Ggz Oost Brabant

Phase

Not applicable

Started

2019-12-16

Last updated

2024-12-05

Condition(s) studied

Depressive DisorderAnxiety Disorders

Investigational drug(s) / intervention(s)

StayFine guided app-based personalised intervention modulesStayFine app-based monitoring

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.

Study 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.

Eligibility

Sex

ALL

Min age

13 Years

Max age

21 Years

Healthy volunteers

Accepted

Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria at entry of the study: * Age 13-21 years * Adolescents who do NOT meet criteria of a current anxiety disorder (separation -, social - or generalized anxiety disorder, specific phobia, panic disorder, agoraphobia) or depressive disorder (major depressive -, persistent depressive -, or disruptive mood dysregulation disorder) based on a semi-structured diagnostic interview (Kiddie Schedule for Affective Disorders and Schizophrenia - lifetime version (K-SADS-PL DSM-5)), but DO meet the criteria for at least one PREVIOUS episode of one or the combination of the above mentioned disorders Exclusion Criteria: * A potential subject who currently meets criteria of any of the following mental health problems will be excluded from participation in this study: * Alcohol or drug misuse * Previous hypomania and/or mania * Bipolar disorder * Previous and/or current psychotic episode Other exclusion criteria include: * Only in remission of another anxiety or mood disorder than mentioned above at the inclusion criteria, namely premenstrual dysphoric disorder, depressive disorder due to another medical condition, substance/medication-induced depressive disorder, other specified depressive disorder, unspecified depressive disorder, selective mutism, substance/medication-induced anxiety disorder or anxiety disorder due to another medical condition, other specified anxiety disorder, unspecified anxiety disorder * only in remission of PTSD or OCD * ongoing current treatment (more than twice a month) for a mental health disorder including those listed under the inclusion criteria * no or insufficient mastery of the Dutch language.

Primary outcome measure(s)

Time to anxiety and/or depressive relapse — up to 36 months (planned: 0, 4, 12, 24, 36 months)
Time to anxiety and/or depressive relapse over 36 months as assessed by a semi-structured interview: the Kiddie Schedule for Affective Disorders and Schizophrenia - lifetime version (K-SADS-PL DSM-5).

Trial sites (1)

Facility	City	Region	Status
GGZ Oost Brabant	Boekel	Netherlands

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05551468 on ClinicalTrials.gov ↗ ← All trials in the Netherlands