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

NCT05551468 | Active Not Recruiting

• 1 other identifier: 636310007
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Anxiety Disorders

Keywords

Prevention; Relapse; Child and adolescents psychiatry; Mental Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of relapses

  up to 36 months (planned: 0, 4, 12, 24, 36 months)

• Duration of relapse in days

  up to 36 months (planned: 0, 4, 12, 24, 36 months)

• Global Assessment of Functioning Scale (GAF)

  up to 36 months (planned: 0, 4, 12, 24, 36 months)

• Revised Children's Anxiety and Depression Scale (RCADS)

  up to 36 months (planned: 0, 4, 12, 24, 36 months)

• Beck Depression Inventory (BDI)

  up to 36 months (planned: 0, 4, 12, 24, 36 months)

Other Outcomes (17)

• Descriptives

  0, 4, 12, 24, 36 months

• Ecological Momentary Assessment (affect, thoughts and social company)

  0, 4, 12, 24, 36 months

• Wearable data (physical activity)

  0, 4, 12, 24, 36 months

Study Arms (2)

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.

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.

Behavioral: StayFine app-based monitoring

Interventions

StayFine guided app-based personalised intervention modules BEHAVIORAL

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 + Intervention modules

StayFine app-based monitoring BEHAVIORAL

Monitoring six times per day for two weeks in the StayFine app.

Monitoring; Monitoring + Intervention modules

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• only in remission of PTSD or OCD
• no or insufficient mastery of the Dutch language.

Sponsors & Collaborators

• Ggz Oost Brabant: lead
• University of Groningen: collaborator
• Amsterdam UMC, location AMC: collaborator
• Accare: collaborator
• RINO ZUID: collaborator

Study Sites (1)

GGZ Oost Brabant

Boekel, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 37840790 BACKGROUND

• 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.

  PMID: 35513189 BACKGROUND

• Robberegt 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.

  PMID: 36521888 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Depressive Disorder; Anxiety Disorders; Recurrence; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Officials

• Yvonne Stikkelbroek, PhD

  Ggz Oost Brabant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 22, 2022
• Study Start: December 16, 2019
• Primary Completion (Estimated): November 21, 2027
• Study Completion (Estimated): November 21, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

NL (1)