Administrative information
Title | ENgage YOung people earlY (ENYOY): A mixed-method study design for a digital transdiagnostic clinical – and peer- moderated treatment platform for youth with beginning mental health complaints in the Netherlands. |
---|---|
Trial registration | Netherlands Trial Register number ID NL8966 (retrospectively registered 19/10/2020). |
Protocol version | Protocol version 1.0, 30 September 2020 |
Funding | Financial funding by The Netherlands Organisation for Health Research and Development, for personnel, materials, and implementation. File number 60–63600–98-319 |
Author details | van Doorn M 1, Popma A 1, van Amelsvoort T 2, McEnery C 34, Gleeson JF 45, Öry FG 6, Jaspers MWM 1, Alvarez-Jimenez M 34, Nieman DH 1 1. Amsterdam UMC, Amsterdam, the Netherlands 2. Maastricht University, Department of Psychiatry and Neuropsychology Maastricht, the Netherlands 3. Centre for Youth Mental Health, The University of Melbourne, Australia 4. Orygen, Parkville, Victoria, Australia 5. Healthy Brain and Mind Research Centre, School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia 6. Buurtzorg Jong, Almelo, the Netherlands |
Name and contact information for the trial sponsor | The Netherlands Organisation for Health Research and Development
Location
Laan van Nieuw Oost-Indië 334 2593 CE Den Haag, the Netherlands
Postal address
Postbus 93,245 2509 AE Den Haag, the Netherlands Phone 070349 51 11 Fax 070349 51 00 E-mail info@zonmw.nl Administered at the Kamer van Koophandel Den Haag (27365263). The Netherlands Organisation for Health Research and Development is noted as Algemeen Nut Beogende Instelling (ANBI). Fiscal number: 0028.76.528. |
Role of sponsor | Monitoring function, check on progress of the study. The sponsor/investigator will submit a summary of the progress of the trial to the accredited METC once a year. Information will be provided on the date of inclusion of the first subject, numbers of subjects included and numbers of subjects that have completed the trial, serious adverse events/serious adverse reactions, other problems, and amendments. |
Introduction
Background and rationale
Stage | Description |
---|---|
Stage 0 | Asymptomatic individuals at risk of a disorder who have not yet presented for care |
Stage 1a | Help-seeking individuals with mild symptoms and mild functional impairment |
Stage 1b | People with attenuated syndromes with partial specificity, often with mixed or ambiguous symptoms and moderate functional impairment |
Stage 2 | People with discrete disorders: clear episodes of psychotic, manic, or severe depressive symptoms |
Stage 3 | People with recurrent or persistent disorders |
Stage 4 | People with severe, treatment-resistant, or unremitting disorder |
Objectives
Trial design
Methods: participants, interventions and outcomes
Study setting
Eligibility criteria
Inclusion criteria
Exclusion criteria
Who will take informed consent?
Intervention description
Criteria for discontinuing or modifying allocated interventions
Strategies to improve adherence to interventions
Relevant concomitant care permitted or prohibited during the trial
Outcomes
-
Psychological Distress assessed with the Kessler Psychological Distress Scale (K10, [43]).
-
Social and Occupational Functioning Assessment Scale (SOFAS, [44]).
-
Stress biomarkers with a smart-watch. Participating clients who are interested will receive a smart-watch that continuously monitors relevant physiological markers of stress during 3 weeks. Available technology (e.g. the TIQ watch E2) is validated, and can measure heart rate variability. In this way, both incidental and cumulative stress can be validly assessed in a naturalistic setting. The participants will receive a short introduction for use about the watch. They can check their stress under different circumstances to discover the relationship between their activities and stress. The watch could also be used during their visits to the ENYOY site to measure the changes in stress level during exercises on the platform, such as mindfulness exercises, self-compassion elements and the anxiety program.
-
“Websites journeys” of visitors (number of visits, number of selected activities etc.) will be collected. The website journeys will be anonymously logged under a system generated ID number and session number.
-
Open questions asked in an digital online meeting (using MS teams) regarding usability, user friendliness, accessibility, acceptability, connection among peers, and contribution of the platform. The focus will lie on subjective meaning-giving and context, thereby focusing on the individual. The experience and interpretation of the participants will be explored. The presented results will form descriptions and insights into the core constructs, and help improve the ENYOY platform further.