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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 (ENYOY:nextstep)

13 maggio 2026 aggiornato da: Prof. Dr. Arne Popma, Academisch Medisch Centrum - Amsterdam UMC Research BV

ENgage YOung People earlY: the Next Steps

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)

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Stimato)

225

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Experimental condition
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.
Comportamentale: ENYOY

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.

Altri nomi:
  • MOST
Altro: Control condition
Young people in the control condition receive Care As Asual.
Altro: Care As Usual
Young people in the control condition receive Care As Usual.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Psychological distress
Lasso di tempo: At 3-month follow-up
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Psychological distress
Lasso di tempo: At 6-, and 12-month follow-up
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
Lasso di tempo: at 3-month, 6-month, and 12-month follow-up
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
Lasso di tempo: at 3-month, 6-month, and 12-month follow-up
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
Lasso di tempo: at 3-month, 6-month, and 12-month follow-up
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
Lasso di tempo: at 3-month, 6-month, and 12-month follow-up
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
Lasso di tempo: at 3-month, 6-month, and 12-month follow-up
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
Lasso di tempo: at 3-month, 6-months, and 12-month follow-up
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
Lasso di tempo: at 3-month, 6-month, and 12-month follow-up
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
Lasso di tempo: at 3-month, 6-month, and 12-month follow-up
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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Reach
Lasso di tempo: at 3-month, 6-month, and 12-month follow-up
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
Lasso di tempo: 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
Lasso di tempo: at 3-month, 6-month, and 12-month follow-up
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
Lasso di tempo: at 3-month, 6-month, and 12-month follow-up
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
Lasso di tempo: at 3-month, 6-month, and 12-month follow-up
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Academisch Medisch Centrum - Amsterdam UMC Research BV

Collaboratori

Levvel
Psychiatric Clinic of Mondriaan Heerlen-Maastricht

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

18 maggio 2026

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • NL-010792

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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