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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. Mai 2026 aktualisiert von: 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)

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Geschätzt)

225

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: 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.

Andere Namen:
  • MOST
Sonstiges: Control condition
Young people in the control condition receive Care As Asual.
Sonstiges: Care As Usual
Young people in the control condition receive Care As Usual.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Psychological distress
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Psychological distress
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Reach
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Academisch Medisch Centrum - Amsterdam UMC Research BV

Mitarbeiter

Levvel
Psychiatric Clinic of Mondriaan Heerlen-Maastricht

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

18. Mai 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

6. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Mai 2026

Zuerst gepostet (Tatsächlich)

19. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • NL-010792

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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