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RecruitingNCT07594756ENYOY:nextstepUpdated Oct 5, 2026

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

An interventional study of ENYOY and Care As Usual in Psychological Distress, sponsored by Academisch Medisch Centrum - Amsterdam UMC Research BV. Recruiting at 1 site in Netherlands. Open to participants aged 16 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Academisch Medisch Centrum - Amsterdam UMC Research BV · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Updated Oct 5, 2026Now RecruitingFirst site in Netherlands+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
16 Years to 25 Years
Sex
All
01

Study summary

This study, run by Amsterdam UMC in the Netherlands, looks at whether an online mental health platform called ENYOY can help reduce psychological distress in young people aged 16 to 25 who are waiting for mental health care.

Young people can take part if they are experiencing mental health problems and are currently on a waiting list for mental health care. The study lasts 12 months. During this time, participants complete questionnaires four times: at the start of the study and after 3, 6, 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: receives care as usual.

Young people in the intervention group can use the platform for the duration of the study, with three months of guidance from a coach and/or a peer with lived experience with mental health problems. The platform includes activities based on proven psychological methods. These activities help with issues such as low mood, anxiety, sleep problems, and low confidence. Participants also have 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 reduce psychological distress and improve participants' mental health. There are no known risks associated with 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).

Read the 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 health care. Outcomes will be compared between participants who receive access to ENYOY in addition to care as usual and those who receive care as usual alone.

Young people in the Netherlands aged 16 to 25 years who report mental health difficulties and are currently on a waiting list for mental health care services are eligible to participate. Participants will complete self-report questionnaires at four time points (at the start of the study and at 3, 6, and 12 months).

Following the 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 for three months from a coach and/or a peer with lived experience with mental health difficulties. 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).

02

Conditions studied

  • Psychological Distress

Keywords

  • Psychological distress
  • Young people
  • DMHI
  • ENYOY
  • MOST
  • Waiting list
03

In context

Lead sponsor

This is the only study on the registry with Academisch Medisch Centrum - Amsterdam UMC Research BV as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 25 Years
Sexes eligible
All
Accepts 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.
  • 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
225 participants (estimated)

Study arms

  • 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.

    Behavioral: ENYOY

  • Other
    Control condition

    Young people in the control condition receive Care As Asual.

    Other: Care As Usual

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 they 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.

    Also known as: MOST

  • OtherCare As Usual

    Young people in the control condition receive Care As Usual.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At 3-month follow-up

Secondary outcomes

  1. 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.

    Time frame: At 6-, and 12-month follow-up

  2. Functioning

    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.

    Time frame: at 3-month, 6-month, and 12-month follow-up

  3. 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.

    Time frame: at 3-month, 6-month, and 12-month follow-up

  4. 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.

    Time frame: at 3-month, 6-month, and 12-month follow-up

  5. 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.

    Time frame: at 3-month, 6-month, and 12-month follow-up

  6. 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.

    Time frame: at 3-month, 6-month, and 12-month follow-up

  7. 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).

    Time frame: at 3-month, 6-months, and 12-month follow-up

  8. 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.

    Time frame: at 3-month, 6-month, and 12-month follow-up

  9. 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.

    Time frame: at 3-month, 6-month, and 12-month follow-up

Other outcomes

  1. Reach

    Reach will be measured using the number of individuals consenting to, participating in, initiating ENYOY, and dropping out during the intervention period.

    Time frame: at 3-month, 6-month, and 12-month follow-up

  2. Adoption

    Adoption will be measured using the number and profile of sites and delivery agents trained and actively delivering ENYOY during the intervention period.

    Time frame: at 3-month, 6-month, and 12-month follow-up

  3. 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.

    Time frame: at 3-month, 6-month, and 12-month follow-up

  4. 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.

    Time frame: at 3-month, 6-month, and 12-month follow-up

  5. Maintenance

    Maintenance will be measured using ENYOY platform-derived usage data and intended continuation of ENYOY use using self-report items.

    Time frame: at 3-month, 6-month, and 12-month follow-up

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 5, 2026
Sites
1 site added — first site in Netherlands
Show site
  • Amsterdam UMC · Amsterdam, Netherlands
Oct 5, 2026
Also revised
eligibility
Show all 1 update
  1. Oct 5, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in Netherlands
    Show site
    • Amsterdam UMC · Amsterdam, Netherlands
    Eligibility Criteria revised
    + 4 other changes: verification date, date precision, description and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07594756
Lead sponsor
Academisch Medisch Centrum - Amsterdam UMC Research BV
Collaborators
Levvel, Psychiatric Clinic of Mondriaan Heerlen-Maastricht
Responsible party
Prof. Dr. Arne Popma (Prof. Dr. Arne Popma, Academisch Medisch Centrum - Amsterdam UMC Research BV) — Principal investigator
First posted
May 19, 2026
Start date
May 18, 2026
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 5, 2026

Study contacts

Fenna Hellegers
Contact
f.hellegers@amsterdamumc.nl
+316 27326769

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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