TY - JOUR
T1 - Personalised app-based relapse prevention of depressive and anxiety disorders in remitted adolescents and young adults
T2 - A protocol of the StayFine RCT
AU - Robberegt, Suzanne J.
AU - Kooiman, Bas E. A. M.
AU - Albers, Casper J.
AU - Nauta, Maaike H.
AU - Bockting, Claudi
AU - Stikkelbroek, Yvonne
N1 - Funding Information: This work is supported by grants from the Netherlands Organisation for Health Research and Development (636310007), GGZ Oost Brabant, Accare, RINO Zuid, University of Groningen and by the Centre for Urban Mental Health of the University of Amsterdam. GGZ Oost Brabant is the sponsor of the study. Contact information of the sponsor: GGZ Oost Brabant, Raad van Bestuur, Postbus 3, 5427 ZG Boekel. Publisher Copyright: © Author(s) (or their employer(s)) 2022.
PY - 2022/12/15
Y1 - 2022/12/15
N2 - Introduction Youth in remission of depression or anxiety have high risks of relapse. Relapse prevention interventions may prevent chronicity. Aim of the study is therefore to (1) examine efficacy of the personalised StayFine app for remitted youth and (2) identify high-risk groups for relapse and resilience. Method and analysis In this Dutch single-blind parallel-group randomised controlled trial, efficacy of app-based monitoring combined with guided app-based personalised StayFine intervention modules is assessed compared with monitoring only. In both conditions, care as usual is allowed. StayFine modules plus monitoring is hypothesised to be superior to monitoring only in preventing relapse over 36 months. Participants (N=254) are 13-21 years and in remission of depression or anxiety for >2 months. Randomisation (1:1) is stratified by previous treatment (no treatment vs treatment) and previous episodes (1, 2 or >3 episodes). Assessments include diagnostic interviews, online questionnaires and monitoring (ecological momentary assessment with optional wearable) after 0, 4, 12, 24 and 36 months. The StayFine modules are guided by certified experts by experience and based on preventive cognitive therapy and ingredients of cognitive behavioural therapy. Personalisation is based on shared decision-making informed by baseline assessments and individual symptom networks. Time to relapse (primary outcome) is assessed by the Kiddie Schedule for Affective Disorders and Schizophrenia-lifetime version diagnostic interview. Intention-to-treat survival analyses will be used to examine the data. Secondary outcomes are 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. Ethics, funding and dissemination The study was approved by METC Utrecht and is funded by the Netherlands Organisation for Health Research and Development (636310007). Results will be submitted to peer-reviewed scientific journals and presented at (inter)national conferences. Trial registration number NCT05551468; NL8237.
AB - Introduction Youth in remission of depression or anxiety have high risks of relapse. Relapse prevention interventions may prevent chronicity. Aim of the study is therefore to (1) examine efficacy of the personalised StayFine app for remitted youth and (2) identify high-risk groups for relapse and resilience. Method and analysis In this Dutch single-blind parallel-group randomised controlled trial, efficacy of app-based monitoring combined with guided app-based personalised StayFine intervention modules is assessed compared with monitoring only. In both conditions, care as usual is allowed. StayFine modules plus monitoring is hypothesised to be superior to monitoring only in preventing relapse over 36 months. Participants (N=254) are 13-21 years and in remission of depression or anxiety for >2 months. Randomisation (1:1) is stratified by previous treatment (no treatment vs treatment) and previous episodes (1, 2 or >3 episodes). Assessments include diagnostic interviews, online questionnaires and monitoring (ecological momentary assessment with optional wearable) after 0, 4, 12, 24 and 36 months. The StayFine modules are guided by certified experts by experience and based on preventive cognitive therapy and ingredients of cognitive behavioural therapy. Personalisation is based on shared decision-making informed by baseline assessments and individual symptom networks. Time to relapse (primary outcome) is assessed by the Kiddie Schedule for Affective Disorders and Schizophrenia-lifetime version diagnostic interview. Intention-to-treat survival analyses will be used to examine the data. Secondary outcomes are 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. Ethics, funding and dissemination The study was approved by METC Utrecht and is funded by the Netherlands Organisation for Health Research and Development (636310007). Results will be submitted to peer-reviewed scientific journals and presented at (inter)national conferences. Trial registration number NCT05551468; NL8237.
KW - anxiety disorders
KW - child & adolescent psychiatry
KW - clinical trials
KW - depression & mood disorders
KW - mental health
KW - preventive medicine
UR - http://www.scopus.com/inward/record.url?scp=85144209863&partnerID=8YFLogxK
U2 - https://doi.org/10.1136/bmjopen-2021-058560
DO - https://doi.org/10.1136/bmjopen-2021-058560
M3 - Article
C2 - 36521888
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e058560
ER -