Depressive DisorderStayFineNCT05551468
StayFine: Personalised Relapse Prevention of Anxiety and Mood Disorders in Youths
A study testing StayFine guided app-based personalised intervention modules and StayFine app-based monitoring in people with Depressive Disorder and Anxiety Disorders, run by Ggz Oost Brabant at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Anxiety Disorders
- What is being tested?
- StayFine guided app-based personalised intervention modules and StayFine app-based monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Dec 2019to 21 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: StayFine: a Personalized Monitoring and Intervention App to Prevent Relapse of Anxiety and Mood Disorders in Youth and Young Adults
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.
Read the 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.
- Conditions
- Depressive Disorder, Anxiety Disorders
- Being tested
- StayFine guided app-based personalised intervention modules, StayFine app-based monitoring
- Keywords
- Prevention, Relapse, Child and adolescents psychiatry, Mental Health
- Medical subject headings
- Depressive Disorder, Anxiety Disorders, Recurrence, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StayFine guided app-based personalised intervention modulesBehavioural
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).
StayFine app-based monitoringBehavioural
Monitoring six times per day for two weeks in the StayFine app.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring + Intervention modules | Experimental | 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. Receives: Behavioral: StayFine guided app-based personalised intervention modules; Behavioral: StayFine app-based monitoring |
| Monitoring | Active comparator | 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. Receives: Behavioral: StayFine app-based monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 36 months (planned: 0, 4, 12, 24, 36 months)
Secondary outcomes (6)
Number of relapses
Measured during each semi-structured interview (K-SADS-PL DSM-5). An extra interview may be scheduled if relapse is expected.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 0, 4, 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start16 Dec 2019
- Primary completion21 Nov 2027 (estimated)
- Study completion21 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ggz Oost Brabant
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen, Amsterdam UMC, location AMC, Accare, RINO ZUID
- Responsible party
- Sponsor
- Investigators
- Yvonne Stikkelbroek, PhD, Principal investigator, Ggz Oost Brabant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551468
- Sponsor's protocol ID
- 636310007
- Acronym
- StayFine
- Status last verified
- Dec 2024
- First submitted
- 29 Aug 2022
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35513189Kooiman BEAM, Robberegt SJ, Albers CJ, Bockting CLH, Stikkelbroek YAJ, Nauta MH. Congruency of multimodal data-driven personalization with shared decision-making for StayFine: individualized app-based relapse prevention for anxiety and depression in young people. Front Psychiatry. 2023 Sep 29;14:1229713. doi: 10.3389/fpsyt.2023.1229713. eCollection 2023.
PubMed 37840790Robberegt SJ, Kooiman BEAM, Albers CJ, Nauta MH, Bockting C, Stikkelbroek Y. Personalised app-based relapse prevention of depressive and anxiety disorders in remitted adolescents and young adults: a protocol of the StayFine RCT. BMJ Open. 2022 Dec 15;12(12):e058560. doi: 10.1136/bmjopen-2021-058560.
PubMed 36521888
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StayFine: a Personalized Monitoring and Intervention App to Prevent Relapse of Anxiety and Mood Disorders in Youth and Young Adults
- ClinicalTrials.gov ID
- NCT05551468
- Acronym / sponsor ID
- StayFine / 636310007
- Conditions
- Depressive Disorder, Anxiety Disorders
- Keywords
- Prevention, Relapse, Child and adolescents psychiatry, Mental Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Ggz Oost BrabantUniversity, hospital or other
- Collaborators
- University of Groningen, Amsterdam UMC, location AMC, Accare, RINO ZUID
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 21 Nov 2027 (estimated)
- Study completion
- 21 Nov 2027 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring + Intervention modules | Experimental | Behavioral: StayFine guided app-based personalised intervention modules, Behavioral: StayFine app-based monitoringMonitoring: 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 | Active comparator | Behavioral: StayFine app-based monitoringMonitoring: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. |
Who may qualify
- Ages
- 13 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StayFine guided app-based personalised intervention modulesParticipants 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). | Behavioural | Monitoring + Intervention modules |
| StayFine app-based monitoringMonitoring six times per day for two weeks in the StayFine app. | Behavioural | Monitoring, Monitoring + Intervention modules |
Primary outcome
Time to anxiety and/or depressive relapse
Time frame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
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).
6 secondary outcomes
Number of relapses
Time frame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
Duration of relapse in days
Time frame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
Global Assessment of Functioning Scale (GAF)
Time frame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
Revised Children's Anxiety and Depression Scale (RCADS)
Time frame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
Beck Depression Inventory (BDI)
Time frame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
Dutch version of the EuroQol Questionaire (EQ-5D-Y)
Time frame: 0, 4, 12, 24, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Background: PubMed 35513189Robberegt 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 publication: PubMed 37840790Kooiman BEAM, Robberegt SJ, Albers CJ, Bockting CLH, Stikkelbroek YAJ, Nauta MH. Congruency of multimodal data-driven personalization with shared decision-making for StayFine: individualized app-based relapse prevention for anxiety and depression in young people. Front Psychiatry. 2023 Sep 29;14:1229713. doi: 10.3389/fpsyt.2023.1229713. eCollection 2023.
- Derived from this study: PubMed 36521888Robberegt SJ, Kooiman BEAM, Albers CJ, Nauta MH, Bockting C, Stikkelbroek Y. Personalised app-based relapse prevention of depressive and anxiety disorders in remitted adolescents and young adults: a protocol of the StayFine RCT. BMJ Open. 2022 Dec 15;12(12):e058560. doi: 10.1136/bmjopen-2021-058560.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Stikkelbroek, PhD principal investigator
Ggz Oost Brabant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StayFine guided app-based personalised intervention modules and StayFine app-based monitoring in people with Depressive Disorder and Anxiety Disorders, run by Ggz Oost Brabant at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to anxiety and/or depressive relapse (time frame: up to 36 months (planned: 0, 4, 12, 24, 36 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05551468, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.