跳至主要内容
临床试验/NCT06451549
NCT06451549撤回不适用

Real-world Evaluation of a Recommender System for Mental Health Self-management

Newcastle University8 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
500
试验地点
8
主要终点
Depression Severity

研究概览

简要总结

Mental health concerns are a growing global concern, but support can still be difficult to access. Digital health technologies can help people access support, but with over 10,000 mental health apps available, it can be difficult to choose one that is safe, effective, and personalised. Syndi is a digital health platform that uses a machine learning system to provide personalised recommendations of mental health apps. This study aims to examine the impact of Syndi and its recommendations on the mental health and well-being of people with mental health concerns.

The investigators will use the standard National Health Service (NHS) Talking Therapies measures of anxiety and depression, as well as additional measures of wellbeing and functional impairment to look at the impact of Syndi on patients' mental well-being. The investigators will also look at user experience with Syndi using a survey. Users' engagement with Syndi and its recommended apps will be assessed using a short survey and some participants will be randomly selected for an interview so the investigators can get a better understanding of what people liked and disliked about using the platform and why.

The investigators expect that the project will show that using Syndi helps improve mental well-being in people with mental health concerns. If the study shows this positive impact, this will provide evidence to support the use of Syndi to improve the accessibility of mental health support in clinical pathways. The investigators will publish the results of the study in academic journals as well as in more accessible platforms.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

As this is a single arm study, all participants will receive the intervention and no masking is required.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Based in the UK
  • Referred or self-referred to proceed through the standard NHS Talking Therapies care pathway OR people with mental health concerns looking for app recommendations online;
  • Willing and able to provide informed consent;
  • Aged 18 years or older;
  • Able to speak English;
  • Have access to the internet and own a smartphone.

排除标准

  • Patients with a PHQ-9 score >=20
  • Patients with suicidal ideation measured as an answer of 'YES' to any question in the Columbia Suicide Severity Rating Scale (C-SSRS);
  • Incapable of self-consent;
  • In a dependent/unequal relationship with the research or care teams or any PPI representatives.

结局指标

主要结局

Depression Severity

时间窗: 2 weeks and 3 months post-baseline

Score on the Patient Health Questionnaire-9 (PHQ-9), total scores range from 0 to 27 (higher scores indicate more severe depression)

次要结局

  • Anxiety Severity(2 weeks and 3 months post-baseline)
  • Engagement with recommended apps(2 weeks post-baseline)
  • User perceptions of the recommended apps(Semi-structured interview call, 2 months after start of the trial)
  • Mental Wellbeing(2 weeks and 3 months post-baseline)
  • Functional Impairment(2 weeks and 3 months post-baseline)
  • User experience with the Syndi recommender system(Immediately after app recommendations and at 2 weeks post-baseline)
  • User perceptions of the system(Semi-structured interview call, 2 months after start of the trial)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edward Meinert

Professor of Digital Health and Clinical Artificial Intelligence

Newcastle University

研究点 (8)

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