Skip to content

StayFine RCT: app-based anxiety and depression relapse prevention in adolescents

Personalized relapse prevention for anxiety and depressive disorders using the StayFine app: a randomized controlled trial in adolescents and young adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22807
Enrollment
254
Registered
2019-12-15
Start date
2019-12-16
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Anxiety disorders, depressive disorders.

Interventions

Monitoring: Ecological Momentary Assessment (EMA) of affect and activity level. Six times per day for two weeks. Timepoints: T0-T4. Intervention: StayFine guided app-based modular intervention. Each

Sponsors

GGZ Oost Brabant
Lead Sponsor

Eligibility

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 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 -, disruptive mood dysregulation disorder or other specified depressive disorder) based on a semi-structured diagnostic interview (SCID-5 or SCID-junior), 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 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, other specified anxiety disorder, unspecified anxiety disorder, and only in remission of PTSD or OCD and any other mental health 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
Time to anxiety and/or depressive relapse over 36 months as assessed by a semi-structured interview.

Secondary

MeasureTime frame
Descriptives / potential moderators: demographics, nr of previous episodes, previous care, comorbidity Secondary outcomes Depressive symptoms, anxiety symptoms, global functioning, quality of life Exploratory endpoints daily means, fluctuations and inertia of affect, heart rate Potential mediators emotional regulation, beliefs, coping, activity, stress, sleep, flourishing, activity level Serious adverse events (suicidal behavior, hospitalization, death) and core symptoms of anxiety and depression will be monitored every three months.

Contacts

Public ContactYvonne Stikkelbroek

University Utrecht

Y.Stikkelbroek@uu.nl0644057782

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)