Clinical trial NCT05551468: StayFine: Personalised Relapse Prevention of Anxiety and Mood Disorders in Youths
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depressive Disorder
Anxiety Disorders
Keywords: Prevention
Relapse
Child and adolescents psychiatry
Mental Health
Lead sponsor: Ggz Oost Brabant
Sponsor class: OTHER
Collaborators: name: University of Groningen
name: Amsterdam UMC, location AMC
name: Accare
name: RINO ZUID
First posted: 2022-09-22
Enrollment: 254
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Time to anxiety and/or depressive relapse
timeFrame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
Secondary outcomes:
measure: Number of relapses
timeFrame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
measure: Duration of relapse in days
timeFrame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
measure: Global Assessment of Functioning Scale (GAF)
timeFrame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
measure: Revised Children's Anxiety and Depression Scale (RCADS)
timeFrame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
measure: Beck Depression Inventory (BDI)
timeFrame: up to 36 months (planned: 0, 4, 12, 24, 36 months)
measure: Dutch version of the EuroQol Questionaire (EQ-5D-Y)
timeFrame: 0, 4, 12, 24, 36 months
Other outcomes:
measure: Descriptives
timeFrame: 0, 4, 12, 24, 36 months
measure: Ecological Momentary Assessment (affect, thoughts and social company)
timeFrame: 0, 4, 12, 24, 36 months
measure: Wearable data (physical activity)
timeFrame: 0, 4, 12, 24, 36 months
measure: Wearable data (diurnal patterns)
timeFrame: 0, 4, 12, 24, 36 months
measure: Dysfunctional Attitude Scale-17 (DAS-17)
timeFrame: 0, 4, 12, 24, 36 months
measure: Positive and negative affect scale (PANAS)
timeFrame: 0, 4, 12, 24, 36 months
measure: Behavioral Activation for Depression Scale short form (BADS-SF)
timeFrame: 0, 4, 12, 24, 36 months
measure: Sleep Reduction Screening Questionnaire (SRSQ)
timeFrame: 0, 4, 12, 24, 36 months
measure: Perceived Stress Scale (PSS-10)
timeFrame: 0, 4, 12, 24, 36 months
measure: Utrechtse Coping Lijst (UCL)
timeFrame: 0, 4, 12, 24, 36 months
measure: Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: 0, 4, 12, 24, 36 months
measure: Dutch Mental Health Continuum-Short Form (MHC-SF)
timeFrame: 0, 4, 12, 24, 36 months
measure: Adapted Multidimensional Scale of Perceived Social Support (MSPSS-N)
timeFrame: 0, 4, 12, 24, 36 months
measure: System Usability Scale (SUS)
timeFrame: 0, 4, 12, 24, 36 months
measure: Service satisfaction scale (SSS) and 3 questions at the end of an intervention module
timeFrame: 0, 4, 12, 24, 36 months
measure: (Serious) adverse events
timeFrame: up to 36 months
measure: Patient Health Questionnaire for Depression and Anxiety (PHQ4)
timeFrame: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 months
Locations:
city: Boekel
country: Netherlands
facility: GGZ Oost Brabant
Study officials:
affiliation: Ggz Oost Brabant
name: Yvonne Stikkelbroek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kooiman 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.
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.