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NCT05551468: StayFine
StayFine: Personalised Relapse Prevention of Anxiety and Mood Disorders in Youths
NA trial testing StayFine guided app-based personalised intervention modules in Depressive Disorder in 254 participants. Participants enrolled and being followed up; not accepting new ones.
21 November 2027
Quick facts
| Lead sponsor | Ggz Oost Brabant |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 254 |
| Start date | 16 December 2019 |
| Primary completion | 21 November 2027 |
| Estimated completion | 21 November 2027 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- StayFine guided app-based personalised intervention modules
- StayFine app-based monitoring
Conditions studied
- Depressive Disorder — all drugs for Depressive Disorder →
- Anxiety Disorders — all drugs for Anxiety Disorders →
Sponsor
Ggz Oost Brabant
Who can join
Adults 13 to 21, any sex, with Depressive Disorder or Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Personalised app-based relapse prevention of depressive and anxiety disorders in remitted adolescents and young adults: a protocol of the StayFine RCT.
Robberegt SJ, Kooiman BEAM, Albers CJ, Nauta MH, et al · · 2022 · cited 6× · PMID 36521888 · DOI 10.1136/bmjopen-2021-058560 -
Examining varying number of intervention-modules and change in individual networks in young people remitted from depression or anxiety: Exploratory outcomes of the StayFine randomized clinical trial.
Robberegt SJ, Albers CJ, Kooiman BEAM, Vuuregge AH, et al · · 2026 · PMID 42181993 · DOI 10.1016/j.nsa.2026.107007
Verify or expand the search:
- PubMed search for NCT05551468
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05551468 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ggz Oost Brabant
- Last refreshed: 5 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05551468.
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