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

Study Overview
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Brief Summary
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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.

Detailed Description
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This study was previously pre-registered in the Netherlands Trial Registry (NTR) on December 15th 2019 with number NL8237. Enrollment started December 16th 2019. This new registry is made because an error was detected in the eligibility criteria listed on the NTR. That registry is taken offline and cannot be updated. Therefore the investigators registered the same study again, but now with updates to correct the wrongly entered information. The previously registered information is available through: https://trialsearch.who.int/Trial2.aspx?TrialID=NL8237 The eligibility criteria and outcomes as defined in the current registry of ClinicalTrials.gov were used from the start of the study and have not been changed during enrollment and recruitment. In the previous registry the use of a chat-group was mentioned in the intervention. Due to feasibility/planning issues, this was never implemented and therefore this is left out of the current registration. The outcome 'heart rate' is left out as well, because this outcome was not used after a switch in the wearable that measures activity level. Both changes were made before the first participant was enrolled in the study. The StayFine app runs on the Minddistrict web-based platform that has a CE-certificate. It states that for the Minddistrict platform is in confirmatory with all relevant provisions of Medical Devices Directive 93/42/EEC in conjunction with the following relevant specifications: EN62304:2006+AC:2008; EN-ISO 14971:2012; EN 82304-1:2017. The StayFine app runs on the Minddistrict web-based platform that has a CE-certificate. It states that for the Minddistrict platform is in conformity with all relevant provisions of Medical Devices Directive 93/42/EEC in conjunction with the following relevant specifications: EN62304:2006+AC:2008; EN-ISO 14971:2012; EN 82304-1:2017.

Official Title
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StayFine: a Personalized Monitoring and Intervention App to Prevent Relapse of Anxiety and Mood Disorders in Youth and Young Adults

Conditions
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Depressive Disorder, Anxiety Disorders

Intervention / Treatment
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* Behavioral: StayFine guided app-based personalised intervention modules
* Behavioral: StayFine app-based monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring + Intervention modules<br>Monitoring: Ecological Momentary Assessment (EMA) of affect, thoughts and social company. Optionally with a wearable to measure activity level. Six times per day for two weeks. Timepoints: T0-T4. Intervention modules: StayFine guided app-based personalised intervention modules. Each individual receives six of eight modules of which three are mandatory and three others are selected based on a personalization procedure. Time point: after T0 over the course of three months. | Behavioral: StayFine guided app-based personalised intervention modules<br>* 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).<br>Behavioral: StayFine app-based monitoring<br>* Monitoring six times per day for two weeks in the StayFine app.<br>|
| Active Comparator: Monitoring<br>Monitoring:Ecological Momentary Assessment (EMA) of affect, thoughts and social company. Optionally with a wearable to measure activity level. Six times per day for two weeks. Timepoints: T0-T4. | Behavioral: StayFine app-based monitoring<br>* Monitoring six times per day for two weeks in the StayFine app.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to anxiety and/or depressive relapse | 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). | up to 36 months (planned: 0, 4, 12, 24, 36 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of relapses | Measured during each semi-structured interview (K-SADS-PL DSM-5). An extra interview may be scheduled if relapse is expected. | up to 36 months (planned: 0, 4, 12, 24, 36 months) | 
| Duration of relapse in days | Measured during each semi-structured interview (K-SADS-PL DSM-5). An extra interview may be scheduled if relapse is expected. | up to 36 months (planned: 0, 4, 12, 24, 36 months) | 
| Global Assessment of Functioning Scale (GAF) | Global functioning (0-100). Higher scores mean a better outcome. Measured during each semi-structured interview. An extra interview may be scheduled if relapse is expected. | up to 36 months (planned: 0, 4, 12, 24, 36 months) | 
| Revised Children's Anxiety and Depression Scale (RCADS) | Anxiety symptoms (0-3 for 31 items). Higher scores mean a worse outcome. Adapted self-report questionnaire RCADS (only including anxiety subscales, total 31 items). | up to 36 months (planned: 0, 4, 12, 24, 36 months) | 
| Beck Depression Inventory (BDI) | Depressive symptoms (0-3 for 21 items). Higher scores mean a worse outcome. | up to 36 months (planned: 0, 4, 12, 24, 36 months) | 
| Dutch version of the EuroQol Questionaire (EQ-5D-Y) | Quality of life (1-3 for 5 items). Higher scores mean a worse outcome. Quality of life (0-100). Higher scores mean a better outcome. | 0, 4, 12, 24, 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Relapse, Child and adolescents psychiatry, Mental Health