StayFine RCT: app-based anxiety and depression relapse prevention in adolescents
- Conditions
- Anxiety disorders, depressive disorders.
- Registration Number
- NL-OMON22807
- Lead Sponsor
- GGZ Oost Brabant
- Brief Summary
n/a
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 254
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to anxiety and/or depressive relapse over 36 months as assessed by a semi-structured interview.
- Secondary Outcome Measures
Name Time Method Descriptives / potential moderators: <br>demographics, nr of previous episodes, previous care, comorbidity<br><br>Secondary outcomes<br>Depressive symptoms, anxiety symptoms, global functioning, quality of life<br><br>Exploratory endpoints<br>daily means, fluctuations and inertia of affect, heart rate<br><br>Potential mediators<br>emotional regulation, beliefs, coping, activity, stress, sleep, flourishing, activity level<br><br>Serious adverse events (suicidal behavior, hospitalization, death) and core symptoms of anxiety and depression will be monitored every three months.