An interventional study of StayFine guided app-based personalised intervention modules and StayFine app-based monitoring in Depressive Disorder and Anxiety Disorders, sponsored by Ggz Oost Brabant. Active, not recruiting at 1 site in Netherlands. Open to participants aged 13 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Ggz Oost Brabant · Not applicable, Interventional, and Prevention
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.
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.
4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.
This study's planned enrollment of 254 is above the median of 50 across 3,374 interventional studies indexed under Recurrence.
Browse Recurrence studies →Ggz Oost Brabant is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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In order to be eligible to participate in this study, a subject must meet all of the following criteria at entry of the study:
Exclusion Criteria:
Other exclusion criteria include:
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 · Behavioral: StayFine app-based monitoring
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
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).
Monitoring six times per day for two weeks in the StayFine app.
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).
Time frame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
Number of relapses
Measured during each semi-structured interview (K-SADS-PL DSM-5). An extra interview may be scheduled if relapse is expected.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 0, 4, 12, 24, 36 months
Descriptives
Age, ethnicity, education level, living situation, previous episodes, previous care, comorbidity, negative life events
Time frame: 0, 4, 12, 24, 36 months
Ecological Momentary Assessment (affect, thoughts and social company)
StayFine monitoring outcomes (exploratory endpoint): anxious, sad, angry, stressed, fatigue, experiential avoidance, behavioral avoidance, loneliness, activity costs energy (0-100). Higher scores mean a worse outcome. Energetic, relaxed, enthusiastic, happy, pleasurable activity (0-100). Higher scores mean a better outcome. Social company (yes/no).
Time frame: 0, 4, 12, 24, 36 months
Wearable data (physical activity)
StayFine monitoring outcomes (exploratory endpoint): the wearable continuously measures acceleration (i.e. movement, vibration and orientation changes in all 3-axes (x,y,z), converted to score estimates of physical activity). The unit of measure is mg (gravitational acceleration). Higher scores mean more activity.
Time frame: 0, 4, 12, 24, 36 months
Wearable data (diurnal patterns)
StayFine monitoring outcomes (exploratory endpoint): the wearable continuously measures acceleration (i.e. movement, vibration and orientation changes in all 3-axes (x,y,z), converted to score estimates of physical activity and sleep. This can be converted into diurnal patterns based on time of the day and amount of physical activity and sleep.
Time frame: 0, 4, 12, 24, 36 months
Dysfunctional Attitude Scale-17 (DAS-17)
Dysfunctional attitudes (1-7 for 17 items). Higher scores mean a worse outcome.
Time frame: 0, 4, 12, 24, 36 months
Positive and negative affect scale (PANAS)
Positive and negative affect (1-5 for 20 items). Higher scores on the 10 positive affect items mean a better outcome. Higher scores on the 10 negative affect items mean a worse outcome.
Time frame: 0, 4, 12, 24, 36 months
Behavioral Activation for Depression Scale short form (BADS-SF)
Behavioral Activation (1-7 for 9 items). High scores are consistent with the title of the subscales (e.g., high scores on activation mean more activation and thus a better outcome).
Time frame: 0, 4, 12, 24, 36 months
Sleep Reduction Screening Questionnaire (SRSQ)
Sleep (1-3 for 9 items). Higher scores mean a worse outcome.
Time frame: 0, 4, 12, 24, 36 months
Perceived Stress Scale (PSS-10)
Stress (0-4 for 10 items). Higher scores mean a worse outcome.
Time frame: 0, 4, 12, 24, 36 months
Utrechtse Coping Lijst (UCL)
Coping (1-4 for 47 items). Higher scores mean a better or worse outcome depending on the type of coping (7 in total). For maladaptive strategies higher scores mean a worse outcome, for adaptive strategies higher scores mean a better outcome.
Time frame: 0, 4, 12, 24, 36 months
Brief Experiential Avoidance Questionnaire (BEAQ)
Experiential Avoidance (1-6 for 15 items). Higher scores mean a worse outcome.
Time frame: 0, 4, 12, 24, 36 months
Dutch Mental Health Continuum-Short Form (MHC-SF)
Flourishing (0-5 for 14 items). Higher scores mean a better outcome.
Time frame: 0, 4, 12, 24, 36 months
Adapted Multidimensional Scale of Perceived Social Support (MSPSS-N)
Support (1-7 for 18 items). Higher scores mean a better outcome.
Time frame: 0, 4, 12, 24, 36 months
System Usability Scale (SUS)
Usability of StayFine app (1-5 for 10 items). Higher scores mean a better outcome.
Time frame: 0, 4, 12, 24, 36 months
Service satisfaction scale (SSS) and 3 questions at the end of an intervention module
Satisfaction with StayFine intervention modules measured using the SSS (1-4 for 4 items). Higher scores mean a better outcome. Satisfaction measured using two '0-100' questions at the end of an intervention module. Higher scores mean a better outcome. One open ended question.
Time frame: 0, 4, 12, 24, 36 months
(Serious) adverse events
If the participants reports an adverse event, it will be registered. During each semi-structured interview, it will be asked as well.
Time frame: up to 36 months
Patient Health Questionnaire for Depression and Anxiety (PHQ4)
A short 4-item screener for core symptoms of anxiety and depression is administered every three months and once extra after the first month (0-3 for 4 items).
Time frame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 months
Plan to share: Undecided
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Ggz Oost Brabant