Investigating the (Cost-)Effectiveness of an Online Social Therapy Platform (ENYOY) for Young People Aged 16-25 on Mental Healthcare Waiting Lists (ENYOY:nextstep)
2026년 5월 13일 업데이트: 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)
연구 개요
상세 설명
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).
연구 유형
중재적
등록 (추정된)
225
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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다른: Control condition
Young people in the control condition receive Care As Asual.
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Young people in the control condition receive Care As Usual.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Psychological distress
기간: At 3-month follow-up
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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.
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At 3-month follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Psychological distress
기간: 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
|
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Functioning
기간: at 3-month, 6-month, and 12-month follow-up
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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.
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at 3-month, 6-month, and 12-month follow-up
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Quality of life
기간: at 3-month, 6-month, and 12-month follow-up
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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.
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at 3-month, 6-month, and 12-month follow-up
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Depression
기간: at 3-month, 6-month, and 12-month follow-up
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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.
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at 3-month, 6-month, and 12-month follow-up
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Anxiety
기간: at 3-month, 6-month, and 12-month follow-up
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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.
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at 3-month, 6-month, and 12-month follow-up
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Self-esteem
기간: at 3-month, 6-month, and 12-month follow-up
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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.
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at 3-month, 6-month, and 12-month follow-up
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Health economic measure
기간: at 3-month, 6-months, and 12-month follow-up
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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).
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at 3-month, 6-months, and 12-month follow-up
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Social media use
기간: at 3-month, 6-month, and 12-month follow-up
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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.
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at 3-month, 6-month, and 12-month follow-up
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Lonliness
기간: at 3-month, 6-month, and 12-month follow-up
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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.
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at 3-month, 6-month, and 12-month follow-up
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Reach
기간: at 3-month, 6-month, and 12-month follow-up
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Reach will be measured using the number of individuals consenting to, participating in, initiating ENYOY, and dropping out during the intervention period.
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at 3-month, 6-month, and 12-month follow-up
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Adoption
기간: at 3-month, 6-month, and 12-month follow-up
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Adoption will be measured using the number and profile of sites and delivery agents trained and actively delivering ENYOY during the intervention period.
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at 3-month, 6-month, and 12-month follow-up
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Implementation
기간: 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.
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at 3-month, 6-month, and 12-month follow-up
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Implementation
기간: at 3-month, 6-month, and 12-month follow-up
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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.
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at 3-month, 6-month, and 12-month follow-up
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Maintenance
기간: at 3-month, 6-month, and 12-month follow-up
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Maintenance will be measured using ENYOY platform-derived usage data and intended continuation of ENYOY use using self-report items.
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at 3-month, 6-month, and 12-month follow-up
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간행물 및 유용한 링크
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 18일
기본 완료 (추정된)
2028년 12월 31일
연구 완료 (추정된)
2028년 12월 31일
연구 등록 날짜
최초 제출
2026년 5월 6일
QC 기준을 충족하는 최초 제출
2026년 5월 13일
처음 게시됨 (실제)
2026년 5월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 13일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .