ENgage YOung People earlY: the Next Steps
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 225
- 主要终点
- Psychological distress
研究概览
简要总结
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)
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: ENYOY (Behavioral)
Control condition
Young people in the control condition receive Care As Asual.
干预措施: Care As Usual (Other)
结局指标
主要结局
Psychological distress
时间窗: 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.
次要结局
- Psychological distress(At 6-, and 12-month follow-up)
- Functioning(at 3-month, 6-month, and 12-month follow-up)
- Quality of life(at 3-month, 6-month, and 12-month follow-up)
- Depression(at 3-month, 6-month, and 12-month follow-up)
- Anxiety(at 3-month, 6-month, and 12-month follow-up)
- Self-esteem(at 3-month, 6-month, and 12-month follow-up)
- Health economic measure(at 3-month, 6-months, and 12-month follow-up)
- Social media use(at 3-month, 6-month, and 12-month follow-up)
- Lonliness(at 3-month, 6-month, and 12-month follow-up)
研究者
Prof. Dr. Arne Popma
Prof. Dr. Arne Popma
Academisch Medisch Centrum - Amsterdam UMC Research BV