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

Официальное название

ENgage YOung People earlY: the Next Steps

Обзор

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)

Подробное описание

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).

Вмешательства

• Поведенческое 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 exp
• Другое Care As Usual
  Young people in the control condition receive Care As Usual.

Первичные конечные точки

• Psychological distress [Срок оценки: At 3-month follow-up]

Вторичные конечные точки (9)

• Psychological distress [Срок оценки: At 6-, and 12-month follow-up]
• Functioning [Срок оценки: at 3-month, 6-month, and 12-month follow-up]
• Quality of life [Срок оценки: at 3-month, 6-month, and 12-month follow-up]
• Depression [Срок оценки: at 3-month, 6-month, and 12-month follow-up]
• Anxiety [Срок оценки: at 3-month, 6-month, and 12-month follow-up]
• Self-esteem [Срок оценки: at 3-month, 6-month, and 12-month follow-up]
• Health economic measure [Срок оценки: at 3-month, 6-months, and 12-month follow-up]
• Social media use [Срок оценки: at 3-month, 6-month, and 12-month follow-up]
• Lonliness [Срок оценки: at 3-month, 6-month, and 12-month follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07594756 · NL-010792

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗