一项针对世界卫生组织数字心理健康干预措施“循序渐进”的1型有效性-实施随机对照试验方案，该干预措施旨在解决中国澳门特别行政区中国青年成年人的抑郁症问题。
A protocol for a type 1 effectiveness-implementation randomized controlled trial of the WHO digital mental health intervention Step-by-Step to address depression among Chinese young adults in Macao (SAR), China.
作者信息
Sit Hao Fong, Li Gen, Chen Wen, Sou Elvo Kuai Long, Wong Mek, Burchert Sebastian, Hong Ieng Wai, Sit Ho Yi, Lam Agnes Iok Fong, Hall Brian J
机构信息
Department of Psychology, The University of Hong Kong, Pokfulam, Hong Kong (SAR), People's Republic of China.
Center for Global Health Equity, New York University (Shanghai), Shanghai, People's Republic of China.
出版信息
Internet Interv. 2022 Sep 28;30:100579. doi: 10.1016/j.invent.2022.100579. eCollection 2022 Dec.
BACKGROUND
Among Chinese college students, the burden of depression is considerably high, affecting up to 30 % of the population. Despite this burden, few Chinese students seek mental health treatment. In addition, depression is highly comorbid with other mental health disorders, such as anxiety. Scalable, transdiagnostic, evidence-based interventions are needed for this population.
OBJECTIVE
The study will evaluate the effectiveness of a World Health Organization transdiagnostic digital mental health intervention, Step-by-Step, to reduce depressive and anxiety symptoms and improve well-being compared with enhanced care as usual and its implementation in a Chinese university community.
METHODS
A type 1 effectiveness-implementation two-arm, parallel, randomized controlled trial will be conducted. The two conditions are 1) the 5-session Step-by-Step program with minimal guidance by trained peer-helpers and 2) psychoeducational information on depression and anxiety and referrals to local community services. A total of 334 Chinese university students will be randomized with a 1:1 ratio to either of the two groups. Depression, anxiety, wellbeing, and client defined problems will be assessed at pre-intervention, post-intervention, and 3-month follow-up. Endline qualitative interviews and focus group discussions will be conducted to explore SbS implementation among service users, university staff, and stakeholders. Data will be analysed based on the intent-to-treat principle.
DISCUSSION
Step-by-Step is an innovative approach to address common mental health problems in populations with sufficient digital literacy. It is a promising intervention that can be embedded to scale mental health services within a university setting. It is anticipated that after successful evaluation of the program and its implementation in the type 1 hybrid design RCT study, Step-by-Step can be scaled and maintained as a low-intensity treatment in universities, and potentially extended to other populations within the Chinese community.
TRIAL REGISTRATION
ChiCTR2100050214.
背景
在中国大学生中，抑郁症负担相当高，影响高达30%的人群。尽管有这种负担，但很少有中国学生寻求心理健康治疗。此外，抑郁症与其他心理健康障碍（如焦虑症）高度共病。这一人群需要可扩展的、跨诊断的、循证干预措施。
目的
本研究将评估世界卫生组织的跨诊断数字心理健康干预措施“步步为营”与强化常规护理相比，在减轻抑郁和焦虑症状以及改善幸福感方面的有效性，以及在一所中国大学社区中的实施情况。
方法
将进行一项1型有效性-实施双臂平行随机对照试验。两种情况分别为：1）由受过培训的同伴辅助者提供最少指导的5节“步步为营”课程；2）关于抑郁和焦虑的心理教育信息以及转介到当地社区服务机构。总共334名中国大学生将按1:1的比例随机分为两组。将在干预前、干预后和3个月随访时评估抑郁、焦虑、幸福感和服务对象确定的问题。将进行终期定性访谈和焦点小组讨论，以探讨“步步为营”在服务对象、大学工作人员和利益相关者中的实施情况。数据将根据意向性分析原则进行分析。
讨论
“步步为营”是一种创新方法，用于解决具有足够数字素养人群中的常见心理健康问题。它是一种有前景的干预措施，可以嵌入到大学环境中以扩大心理健康服务规模。预计在1型混合设计随机对照试验研究中对该项目及其实施进行成功评估后，“步步为营”可以作为一种低强度治疗方法在大学中扩大规模并维持下去，并有可能扩展到中国社区内的其他人群。
试验注册
ChiCTR2100050214。
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