Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: study protocol.
Further development and feasibility randomised controlled trial of a digital programme for adolescent depression, MoodHwb: study protocol.
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DOI：
10.1136/bmjopen-2022-070369
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发表时间：
2023-06-05
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
--
作者：
一个名为MoodHwb的数字方案是与患有抑郁症或抑郁症高危人群、父母/照顾者和专业人员共同设计的，目的是为年轻人的情绪和幸福提供支持。初步评价研究为方案理论提供了支持，并发现MoodHwb可以接受使用。这项研究的目的是根据用户的反馈改进方案，并评估更新的版本和研究方法的可接受性和可行性。最初，这项研究将在年轻人的参与下完善MoodHwb，包括在审判前可接受阶段。随后将进行一项多中心可行性随机对照试验，将MoodHwb+常规护理与数字信息包+常规护理进行比较。威尔士和苏格兰将通过学校、心理健康服务、青年服务、慈善机构和自愿自我转介招募多达120名13-19岁有抑郁症症状的年轻人及其父母/照顾者。主要结果是MoodHwb计划(包括使用、设计和内容)以及试验方法(包括招募和保留率)的可行性和可接受性，在 实施后2个月进行评估。次要结果包括对抑郁知识和污名、寻求帮助、幸福感以及抑郁和焦虑症状等领域的潜在影响，在 治疗后2个月测量。卡迪夫大学医学院研究伦理委员会(REC)和格拉斯哥大学医学院、兽医和生命科学学院批准了审判前可接受阶段。这项试验得到了威尔士NHS REC 3(21/WA/0205)、健康研究管理局(HRA)、威尔士健康和护理研究(HCRW)、威尔士大学健康委员会研究和发展(R&D)部门以及威尔士和苏格兰的学校的批准。研究结果将在同行评议的开放获取期刊、会议和在线上向学术、临床和教育受众以及更广泛的公众传播。ISRCTN12437531。
A digital programme, MoodHwb, was codesigned with young people experiencing or at high risk of depression, parents/carers and professionals, to provide support for young people with their mood and well-being. A preliminary evaluation study provided support for the programme theory and found that MoodHwb was acceptable to use. This study aims to refine the programme based on user feedback, and to assess the acceptability and feasibility of the updated version and study methods. Initially, this study will refine MoodHwb with the involvement of young people, including in a pretrial acceptability phase. This will be followed by a multicentre feasibility randomised controlled trial comparing MoodHwb plus usual care with a digital information pack plus usual care. Up to 120 young people aged 13–19 years with symptoms of depression and their parents/carers will be recruited through schools, mental health services, youth services, charities and voluntary self-referral in Wales and Scotland. The primary outcomes are the feasibility and acceptability of the MoodHwb programme (including usage, design and content) and of trial methods (including recruitment and retention rates), assessed 2 months postrandomisation. Secondary outcomes include potential impact on domains including depression knowledge and stigma, help-seeking, well-being and depression and anxiety symptoms measured at 2 months postrandomisation. The pretrial acceptability phase was approved by the Cardiff University School of Medicine Research Ethics Committee (REC) and the University of Glasgow College of Medicine, Veterinary and Life Sciences REC. The trial was approved by Wales NHS REC 3 (21/WA/0205), the Health Research Authority(HRA), Health and Care Research Wales (HCRW), university health board Research and Development (R&D) departments in Wales, and schools in Wales and Scotland. Findings will be disseminated in peer-reviewed open-access journals, at conferences and meetings, and online to academic, clinical, and educational audiences and the wider public. ISRCTN12437531.
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