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| Name | Class |
|---|---|
| Levvel | UNKNOWN |
| Psychiatric Clinic of Mondriaan Heerlen-Maastricht | UNKNOWN |
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This study, run by Amsterdam UMC in the Netherlands, looks at whether an online mental health platform called ENYOY can help improve psychological distress in young people (16-25) who are waiting for mental health care. Young people in the Netherlands aged 16 to 25 can take part if they are experiencing mental health problems, and are currently on a waiting list for mental healthcare. The study lasts 12 months. During this time, participants fill in questionnaires four times (at the start, at 3-months, 6-months, and 12-months). After joining the study, participants are randomly placed into one of two groups:
Participant recruitment will take place from May 2026 to December 2027. Final follow-up assessments are expected to be completed by December 2028. The study is funded by ZonMw. For questions, you can contact Sascha Struijs (s.y.struijs@vu.nl), or Fenna Hellegers (f.hellegers@amsterdamumc.nl)
This study aims to evaluate the (cost-)effectiveness of a digital health platform (ENYOY) in reducing psychological distress among young people experiencing mental health difficulties who are currently on a waiting list for mental healthcare. Outcomes will be compared between participants who receive access to ENYOY in addition to care-as-usual and those receiving care-as-usual alone. Dutch young people aged 16 to 25 years who report mental health difficulties and are currently on a waiting list for mental healthcare services are eligible to participate. Participants will complete self-report questionnaires at four time points (at the start, at 3-months, 6-months, and 12-months) over a 12-month period. Following baseline assessment, participants will be randomly allocated to either the intervention condition (ENYOY plus care-as-usual) or the control condition (care-as-usual only). Participants in the intervention group will receive access to the ENYOY platform, including guidance from a coach and/or a peer with lived experience of mental health difficulties for three months. The platform provides personalised, self-directed therapeutic content, and access to a moderated online peer community. Participants in the control group will continue to receive standard care. Participation may contribute to a reduction in psychological distress and improvements in mental health outcomes. No adverse health risks are anticipated. The study is conducted by Amsterdam UMC, in the Netherlands. Participant recruitment will take place from May 2026 to December 2027. Final follow-up assessments are expected to be completed by December 2028. This study is funded by ZonMw. For further information, please contact Sascha Struijs (s.y.struijs@vu.nl) or Fenna Hellegers (f.hellegers@amsterdamumc.nl).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental condition | Experimental | Young people in this group receive access to the ENYOY platform, along with three months of guidance from a coach and/or a peer with lived experience of mental health difficulties, in addition to Care-As-Usual. |
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| Control condition | Other | Young people in the control condition receive Care As Asual. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENYOY | Behavioral | ENYOY is an evidence-based digital mental health platform co-created with young people. It combines four main elements: interactive therapeutic content, guidence by coaches and/or peers with lived experience with mental health complaints, and a moderated online community. The therapeutic content is based on approaches like cognitive behavioral therapy and is tailored into "journeys" that match a young person's needs, such as improving mood, reducing anxiety, or building confidence. Users can explore activities and build a personal toolkit. The online community offers young people a safe social space where young people can connect, share experiences, and support each other. Engagement is encouraged through discussions, prompts, and optional anonymous participation. Safety is closely monitored through both human moderation and automated systems that detect risk. |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological distress | Psychological distress will be measured using the Clinical Outcomes in Routine Evaluation-10 measurement (Barkham et al., 2013). The minimum score is 0 and the maximum score is 40. Higher scores indicate higher levels of psychological distress. | At 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological distress | Psychological distress will be measured using the Clinical Outcomes in Routine Evaluation-10 measurement (Barkham et al., 2013). The minimum score is 0 and the maximum score is 40. Higher scores indicate higher levels of psychological distress. | At 6-, and 12-month follow-up |
| Functioning |
| Measure | Description | Time Frame |
|---|---|---|
| Reach | Reach will be measured using the number of individuals consenting to, participating in, initiating ENYOY, and dropping out during the intervention period. | at 3-month, 6-month, and 12-month follow-up |
| Adoption |
Inclusion Criteria:
Exclusion Criteria:
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| Label | URL |
|---|---|
| Data from this study will be shared with the YOUTHreach consortium. This study registration descripes the aim and design of their study. | View source |
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Pseudonymized research data from the individual research participants will be shared with the YOUTHReach consortium. See attachment for the registration of their study. Sharing IPD with other researchers is possible upon request.
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| Care As Usual | Other | Young people in the control condition receive Care As Usual. |
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Functioning will be measured using Work and Social Adjustment Scale - youth version (WSAS-Y; Jassi et al., 2020). The minimum score is 0 and the maximum score is 40. Higher scores indicate greater impairment in functioning. |
| at 3-month, 6-month, and 12-month follow-up |
| Quality of life | Quality of life will be measured using the My Life Tracker measurement (MLT; Kwan et al., 2018). The minimum score is 0 and the maximum score is 100. Higher scores indicate a better quality of life. We will also use the Co-created outcome measure (YAG, YOUTHreach consortium). The minimum score is 0 and the maximum score is 124. Higher scores indicate a higher quality of life. | at 3-month, 6-month, and 12-month follow-up |
| Depression | Depression will be measured using the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001). The minimum score is 0 and the maximum is 27. Higher scores indicate a higher level of depression. | at 3-month, 6-month, and 12-month follow-up |
| Anxiety | Anxiety will be measured using the Generalized Anxiety Disorder questionnaire-7 (GAD-7; Spitzer et al., 2006). The minimum score is 0 and the maximum score is 21. Higher scores indicate a higher level of anxiety. | at 3-month, 6-month, and 12-month follow-up |
| Self-esteem | Self-esteem will be measured using the Rosenberg Self-Esteem Scale questionnaire (RSES; Rosenberg, 1965). The minimum score is 0 and the maximum score is 30. Higher scores indicate a higher self-esteem. | at 3-month, 6-month, and 12-month follow-up |
| Health economic measure | Health economic measures will be using the EuroQol - 5 Dimensions - 5 Levels measurement (EQ-5D-5L;EuroQol Research Foundation, 2025; Herdman et al., 2011). The minimum score from the vife dimensions is 11111 and the maximum score is 55555. Higer scores indicate a better health status. We will also use a Resource Use Measurement developed by the YOUTHreach consortium to indicate the resourced used by the young person (RUM; YOUTHreach consortium). | at 3-month, 6-months, and 12-month follow-up |
| Social media use | Social media use will be measured using 8 items of the Compulsive Internet Use Scale (CIUS; Meerkerk et al. 2009). The minimum score is 0 and the maximum score is 32. Higher scores indicate a higher social media usage. | at 3-month, 6-month, and 12-month follow-up |
| Lonliness | Lonliness will be measured using the University of California, Los Angeles (UCLA) Loneliness Scale short form (V3; Russell, 1996). The minimum score is 8 and the maximum score is 32. A higher score indicate greater levels of lonliness. | at 3-month, 6-month, and 12-month follow-up |
Adoption will be measured using the number and profile of sites and delivery agents trained and actively delivering ENYOY during the intervention period.
| at 3-month, 6-month, and 12-month follow-up |
| Implementation | Implementation will be measured by the extent to which ENYOY components are delivered and used as intended, using structured checklists and platform-derived usage data. | at 3-month, 6-month, and 12-month follow-up |
| Implementation | Implementation will be measured using the User Version of the Mobile Application Rating Scale (uMARS; Stoyanov et al., 2016). The minimum score is 1 and the maximum score is 5. Higher score indicate a higher quality of the application. Additionally, a bespoke ENYOY satisfaction measure will be used. | at 3-month, 6-month, and 12-month follow-up |
| Maintenance | Maintenance will be measured using ENYOY platform-derived usage data and intended continuation of ENYOY use using self-report items. | at 3-month, 6-month, and 12-month follow-up |