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Investigating the (Cost-)Effectiveness of an Online Social Therapy Platform (ENYOY) for Young People Aged 16-25 on Mental Healthcare Waiting Lists

ENgage YOung People earlY: the Next Steps

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07594756
Acronym
ENYOY:nextstep
Enrollment
225
Registered
2026-05-19
Start date
2026-05-18
Completion date
2028-12-31
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Distress

Keywords

Psychological distress, Young people, DMHI, ENYOY, MOST, Waiting list

Brief summary

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: * Intervention group: receives access to the ENYOY platform plus care-as-usual. * Control group: receive care-as-usual. Young people in the intervention group can use the platform for the duration of the study period, with three months of guidence by a coach and/or peer with lived experience with mental health complaints. The platform includes activities based on proven psychological methods. These activities help with things like low mood, anxiety, sleep problems, and confidence. They also get support from a coach and/or a peer (someone who has experienced mental health problems themselves), and access to a safe online community where young people can talk, share experiences, and support each other. The community is moderated to keep it safe and supportive. Taking part may help young people feel psychological stress and improve their mental health. There are no known risks from taking part in this study. 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)

Detailed description

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).

Interventions

BEHAVIORALENYOY

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.

OTHERCare As Usual

Young people in the control condition receive Care As Usual.

Sponsors

Academisch Medisch Centrum - Amsterdam UMC Research BV
Lead SponsorOTHER
Levvel
CollaboratorUNKNOWN
Psychiatric Clinic of Mondriaan Heerlen-Maastricht
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

* Age 16-25 years * On a waiting list for mental healthcare * Able and willing to consent * A score of 10 or higher on the CORE-10 questionnaire * Have personal and private access to a computer, smartphone or tablet. * Ability and willingness to nominate an emergency contact person, such as a close family member

Exclusion criteria

* Insufficient command of the Dutch language * Present with acute suicidal behavior or imminent risk of harm to self * If their psychiatric symptoms are due to an organic cause * Prior exposure to ENYOY or MOST

Design outcomes

Primary

MeasureTime frameDescription
Psychological distressAt 3-month follow-upPsychological 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.

Secondary

MeasureTime frameDescription
Psychological distressAt 6-, and 12-month follow-upPsychological 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.
Functioningat 3-month, 6-month, and 12-month follow-upFunctioning 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.
Quality of lifeat 3-month, 6-month, and 12-month follow-upQuality 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.
Depressionat 3-month, 6-month, and 12-month follow-upDepression 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.
Anxietyat 3-month, 6-month, and 12-month follow-upAnxiety 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.
Self-esteemat 3-month, 6-month, and 12-month follow-upSelf-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.
Health economic measureat 3-month, 6-months, and 12-month follow-upHealth 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).
Social media useat 3-month, 6-month, and 12-month follow-upSocial 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.
Lonlinessat 3-month, 6-month, and 12-month follow-upLonliness 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026