Back to resultsStayFine: Personalised Relapse Prevention of Anxiety and Mood Disorders in Youths (StayFine)
Primary Purpose
Depressive Disorder, Anxiety Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
StayFine guided app-based personalised intervention modules
StayFine app-based monitoring
Sponsored by
About this trial
This is an interventional prevention trial for Depressive Disorder focused on measuring Prevention, Relapse, Child and adolescents psychiatry, Mental Health
Eligibility 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 -, 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.
Sites / Locations
- GGZ Oost BrabantRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Monitoring + Intervention modules
Monitoring
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Number of relapses
Measured during each semi-structured interview (K-SADS-PL DSM-5). An extra interview may be scheduled if relapse is expected.
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.
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.
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).
Beck Depression Inventory (BDI)
Depressive symptoms (0-3 for 21 items). Higher scores mean a worse outcome.
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.
Full Information
NCT ID
NCT05551468
First Posted
August 29, 2022
Last Updated
September 20, 2022
Sponsor
Ggz Oost Brabant
Collaborators
University of Groningen, Amsterdam UMC, location AMC, Accare, RINO ZUID
1. Study Identification
Unique Protocol Identification Number
NCT05551468
Brief Title
StayFine: Personalised Relapse Prevention of Anxiety and Mood Disorders in Youths
Acronym
StayFine
Official Title
StayFine: a Personalized Monitoring and Intervention App to Prevent Relapse of Anxiety and Mood Disorders in Youth and Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
December 15, 2025 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ggz Oost Brabant
Collaborators
University of Groningen, Amsterdam UMC, location AMC, Accare, RINO ZUID
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Anxiety Disorders
Keywords
Prevention, Relapse, Child and adolescents psychiatry, Mental Health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
254 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monitoring + Intervention modules
Arm Type
Experimental
Arm Description
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.
Arm Title
Monitoring
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
StayFine guided app-based personalised intervention modules
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
StayFine app-based monitoring
Intervention Description
Monitoring six times per day for two weeks in the StayFine app.
Primary Outcome Measure Information:
Title
Time to anxiety and/or depressive relapse
Description
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)
Secondary Outcome Measure Information:
Title
Number of relapses
Description
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)
Title
Duration of relapse in days
Description
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)
Title
Global Assessment of Functioning Scale (GAF)
Description
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)
Title
Revised Children's Anxiety and Depression Scale (RCADS)
Description
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)
Title
Beck Depression Inventory (BDI)
Description
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)
Title
Dutch version of the EuroQol Questionaire (EQ-5D-Y)
Description
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
Other Pre-specified Outcome Measures:
Title
Descriptives
Description
Age, ethnicity, education level, living situation, previous episodes, previous care, comorbidity, negative life events
Time Frame
0, 4, 12, 24, 36 months
Title
Ecological Momentary Assessment (affect, thoughts and social company)
Description
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
Title
Wearable data (physical activity)
Description
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
Title
Wearable data (diurnal patterns)
Description
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
Title
Dysfunctional Attitude Scale-17 (DAS-17)
Description
Dysfunctional attitudes (1-7 for 17 items). Higher scores mean a worse outcome.
Time Frame
0, 4, 12, 24, 36 months
Title
Positive and negative affect scale (PANAS)
Description
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
Title
Behavioral Activation for Depression Scale short form (BADS-SF)
Description
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
Title
Sleep Reduction Screening Questionnaire (SRSQ)
Description
Sleep (1-3 for 9 items). Higher scores mean a worse outcome.
Time Frame
0, 4, 12, 24, 36 months
Title
Perceived Stress Scale (PSS-10)
Description
Stress (0-4 for 10 items). Higher scores mean a worse outcome.
Time Frame
0, 4, 12, 24, 36 months
Title
Utrechtse Coping Lijst (UCL)
Description
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
Title
Brief Experiential Avoidance Questionnaire (BEAQ)
Description
Experiential Avoidance (1-6 for 15 items). Higher scores mean a worse outcome.
Time Frame
0, 4, 12, 24, 36 months
Title
Dutch Mental Health Continuum-Short Form (MHC-SF)
Description
Flourishing (0-5 for 14 items). Higher scores mean a better outcome.
Time Frame
0, 4, 12, 24, 36 months
Title
Adapted Multidimensional Scale of Perceived Social Support (MSPSS-N)
Description
Support (1-7 for 18 items). Higher scores mean a better outcome.
Time Frame
0, 4, 12, 24, 36 months
Title
System Usability Scale (SUS)
Description
Usability of StayFine app (1-5 for 10 items). Higher scores mean a better outcome.
Time Frame
0, 4, 12, 24, 36 months
Title
Service satisfaction scale (SSS) and 3 questions at the end of an intervention module
Description
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
Title
(Serious) adverse events
Description
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
Title
Patient Health Questionnaire for Depression and Anxiety (PHQ4)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 -, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Robberegt, MSc.
Phone
+31 88 8460001
Email
info@stayfine.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Bas Kooiman, MSc.
Phone
+31 613902366
Email
info@stayfine.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Stikkelbroek, PhD
Organizational Affiliation
Ggz Oost Brabant
Official's Role
Principal Investigator
Facility Information:
Facility Name
GGZ Oost Brabant
City
Boekel
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Robberegt, MSc.
Phone
+31 88 8460001
Email
info@stayfine.nl
First Name & Middle Initial & Last Name & Degree
Bas Kooiman, MSc.
Phone
+31 613902366
Email
info@stayfine.nl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35513189
Citation
Robberegt SJ, Brouwer ME, Kooiman BEAM, Stikkelbroek YAJ, Nauta MH, Bockting CLH. Meta-Analysis: Relapse Prevention Strategies for Depression and Anxiety in Remitted Adolescents and Young Adults. J Am Acad Child Adolesc Psychiatry. 2023 Mar;62(3):306-317. doi: 10.1016/j.jaac.2022.04.014. Epub 2022 May 2.
Results Reference
background
Links:
URL
http://www.stayfine.nl
Description
Related Info
Learn more about this trial
StayFine: Personalised Relapse Prevention of Anxiety and Mood Disorders in Youths
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