Background Most people with mental disorders in communities exposed to adversity in low-income and middle-income countries (LMICs) do not receive effective care. Digital mental health interventions are scalable when digital access is adequate, and can be safely delivered during the COVID-19 pandemic. Objective To examine the effects of a new WHO-guided digital mental health intervention, Step-by-Step, supported by a non-specialist helper in Lebanon, in the context of concurring economic, humanitarian and political crises, a large industrial disaster and the COVID-19 pandemic. Methods We conducted a single-blind, two-arm pragmatic randomised trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among people suffering from depression and impaired functioning. Primary outcomes were depression (Patient Health Questionnaire 9 (PHQ-9)) and impaired functioning (WHO Disability Assessment Schedule-12 (WHODAS)) at post-treatment. Findings 680 people with depression (PHQ-9>10) and impaired functioning (WHODAS>16) were randomised to Step-by-Step or ECAU. Intention-to-treat analyses showed effects on depression (standardised mean differences, SMD: 0.71; 95% CI: 0.45 to 0.97), impaired functioning (SMD: 0.43; 95% CI: 0.21 to 0.65), post-traumatic stress (SMD: 0.53; 95% CI: 0.27 to 0.79), anxiety (SMD: 0.74; 95% CI: 0.49 to 0.99), subjective well-being (SMD: 0.37; 95% CI: 0.12 to 0.62) and self-identified personal problems (SMD: 0.56; 95% CI 0.29 to 0.83). Significant effects on all outcomes were retained at 3-month follow-up. Conclusions Guided digital mental health interventions can be effective in the treatment of depression in communities exposed to adversities in LMICs, although some uncertainty remains because of high attrition. Clinical implications Guided digital mental health interventions should be considered for implementation in LMICs. Trial registration number ClinicalTrials.gov [NCT03720769][1]. Data are available in a public, open access repository. In line with the WHO open-access policy, deidentified data collected for this study are being made available at the DANS repository () at the date of publication. Application of the CC BY V.4.0 licence requires interested users of the data to attribute the original source. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03720769&atom=%2Febmental%2F25%2Fe1%2Fe34.atom

中文翻译：

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黎巴嫩抑郁症的指导性数字健康干预：随机试验

背景 在低收入和中等收入国家 (LMIC) 的社区中，大多数精神障碍患者都没有得到有效的治疗。当数字访问充足时，数字心理健康干预措施是可扩展的，并且可以在 COVID-19 大流行期间安全地提供。目的 研究在同时发生经济、人道主义和政治危机、大规模工业灾难和2019冠状病毒病大流行。方法 我们进行了一项单盲、两臂实用随机试验，在患有抑郁症和功能受损的人群中比较指导式循序渐进和照常加强护理 (ECAU)。主要结果是治疗后的抑郁症（患者健康问卷 9 (PHQ-9)）和功能受损（WHO 残疾评估表 12 (WHODAS)）。结果 680 名患有抑郁症 (PHQ-9>10) 和功能受损 (WHODAS>16) 的人被随机分配到 Step-by-Step 或 ECAU。意向治疗分析显示对抑郁症（标准化平均差，SMD：0.71；95% CI：0.45 至 0.97）、功能受损（SMD：0.43；95% CI：0.21 至 0.65）、创伤后应激（SMD ：0.53；95% CI：0.27 至 0.79）、焦虑（SMD：0.74；95% CI：0.49 至 0.99）、主观幸福感（SMD：0.37；95% CI：0.12 至 0.62）和自我认定的个人问题（SMD：0.56；95% CI 0.29 至 0.83）。在 3 个月的随访中保留了对所有结果的显着影响。结论 有指导的数字心理健康干预可以有效治疗 LMIC 中面临逆境的社区的抑郁症，尽管由于高流失率仍然存在一些不确定性。临床意义 应考虑在中低收入国家实施有指导的数字心理健康干预措施。试验注册号 ClinicalTrials.gov [NCT03720769][1]。数据可在公共、开放访问的存储库中获得。根据 WHO 的开放获取政策，为本研究收集的去识别化数据可在 DANS 存储库中获取（试验注册号 ClinicalTrials.gov [NCT03720769][1]。数据可在公共、开放访问的存储库中获得。根据 WHO 的开放获取政策，为本研究收集的去识别化数据可在 DANS 存储库中获取（试验注册号 ClinicalTrials.gov [NCT03720769][1]。数据可在公共、开放访问的存储库中获得。根据 WHO 的开放获取政策，为本研究收集的去识别化数据可在 DANS 存储库中获取（) 于出版日期。CC BY V.4.0 许可的应用要求对数据感兴趣的用户注明原始来源。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03720769&atom=%2Febmental%2F25%2Fe1%2Fe34.atom