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 maja 2026 zaktualizowane przez: 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)
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Szczegółowy opis
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).
Typ studiów
Interwencyjne
Zapisy (Szacowany)
225
Faza
- Nie dotyczy
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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.
Inne nazwy:
|
|
Inny: Control condition
Young people in the control condition receive Care As Asual.
|
Young people in the control condition receive Care As Usual.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Psychological distress
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Psychological distress
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Reach
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
18 maja 2026
Zakończenie podstawowe (Szacowany)
31 grudnia 2028
Ukończenie studiów (Szacowany)
31 grudnia 2028
Daty rejestracji na studia
Pierwszy przesłany
6 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
13 maja 2026
Pierwszy wysłany (Rzeczywisty)
19 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
19 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
13 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- NL-010792
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .