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StayFine: a personalized monitoring and intervention app to prevent relapse of anxiety and mood disorders in youth and young adults

StayFine: a personalized monitoring and intervention app to prevent relapse of anxiety and mood disorders in youth and young adults - StayFine: relapse prevention of anxiety and mood disorders in youth

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48325
Enrollment
254
Registered
2019-06-19
Start date
2020-01-21
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

angststoornissen en -symptomen Blue fear

Interventions

The guided app-based modular StayFine intervention consists of eight modules, of which three are mandatory and three others are assigned based on a personalization procedure. The intervention is bas
behavioral activation, exposure, wellness and sleep. An app-buddy can be included to provide support. In both conditions adolescents monitor their symptoms five times in three years and feedback an

Sponsors

Universiteit Utrecht
Lead Sponsor

Eligibility

Age
16 Years to 64 Years

Inclusion criteria

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 of 13-21 years - Daily access to a mobile phone with iOs or Android software - Adolescents do NOT currently 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 -, disruptive mood dysregulation disorder or other specified depressive disorder) based on a semi-structured diagnostic interview (K-SADS), but DO meet the criteria for at least one previous episode of one or the combination of the above mentioned disorders

Exclusion criteria

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 PTSD or OCD, or 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, unspecified depressive disorder, selective mutism, substance/medication-induced anxiety disorder or anxiety disorder due to another medical condition, unspecified anxiety disorder, other specified anxiety disorder - ongoing current treatment (more than twice a month) for a mental health disorder other than the disorders listed under the inclusion criteria. - no or insufficient mastery of the Dutch language.

Design outcomes

Primary

MeasureTime frame
The primary outcome is time to relapse over 3 years (that is, cumulative incidence of anxiety and/or depression relapse) in the intervention condition in comparison to the control condition, based on a semi-structured clinical interview (K-SADS).

Secondary

MeasureTime frame
Secondary outcomes are number of relapses, reduction of anxiety or depressive symptoms, and comorbid symptomatology and quality of life. Potential working mechanisms of the intervention will be examined; change in emotional regulation, beliefs, coping, activity, sleep, coping, flourishing, daily means, fluctuations and inertia of affect and activity level and heart rate. In addition, pre-treatment daily emotions and fluctuations will be examined as predictor of the treatment effect and subsequent time intervals of two weeks will be used to explore transition points to resilient stages versus relapse and potential differential mechanisms of change.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)