Investigating the (Cost-)Effectiveness of an Online Social Therapy Platform (ENYOY) for Young People Aged 16-25 on Mental Healthcare Waiting Lists (ENYOY:nextstep)
2026年5月13日 更新者：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)
調査の概要
詳細な説明
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).
研究の種類
介入
入学 (推定)
225
段階
- 適用できない
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Psychological distress
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Psychological distress
時間枠：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
時間枠：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.
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at 3-month, 6-month, and 12-month follow-up
|
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Quality of life
時間枠：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
時間枠：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.
|
at 3-month, 6-month, and 12-month follow-up
|
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Anxiety
時間枠：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.
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at 3-month, 6-month, and 12-month follow-up
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Self-esteem
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reach
時間枠：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
時間枠：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.
|
at 3-month, 6-month, and 12-month follow-up
|
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Implementation
時間枠：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
|
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Implementation
時間枠：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
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Maintenance
時間枠：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
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月18日
一次修了 (推定)
2028年12月31日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年5月6日
QC基準を満たした最初の提出物
2026年5月13日
最初の投稿 (実際)
2026年5月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月19日
QC基準を満たした最後の更新が送信されました
2026年5月13日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。