Background

E-mental health interventions may help to bridge the mental health treatment gap. Evidence on their effectiveness is compelling in high-income countries. Not enough evidence has been generated on their use with communities affected by adversity in low- and middle-income countries. The World Health Organization (WHO), the National Mental Health Programme (NMMP) at Ministry of Public Health (MoPH) in Lebanon and other partners have adapted a WHO intervention called Step-by-Step for use with Lebanese and displaced people living in Lebanon. Step-by-Step is a minimally guided, internet-based intervention for adults with depression. In this study, a feasibility randomised controlled trial (RCT) and a qualitative process evaluation were conducted to explore the feasibility and the acceptability of the research methods, and the intervention, in preparation for two fully powered trials to assess the effectiveness and cost-effectiveness of Step-by-Step in Lebanon.

Method

Participants were recruited through social media. Inclusion criteria were: being able to understand and speak Arabic or English; access to an internet connected device; aged over 18; living in Lebanon; scores above cut-off on the Patient Health Questionnaire and the WHO Disability Assessment Schedule 2.0. Participants were randomly assigned to the intervention or enhanced care as usual. They completed post-assessments eight weeks after baseline, and follow-up assessments another three months later. Primary outcomes were depression and level of functioning, secondary outcomes were anxiety, post-traumatic stress, and well-being. Qualitative interviews were conducted to evaluate the feasibility and acceptability of the research procedures and the intervention.

Results

A total of N = 138 participants, including 33 Syrians, were recruited and randomised into two equal groups. The dropout rate was higher in the control group (73% post- and 82% follow-up assessment) than in the intervention group (63% post- and 72% follow-up assessment). The intervention was perceived as relevant, acceptable and beneficial to those who completed it. Suggestions were made to further adapt the content and to make the intervention more engaging. Statistical analyses were conducted despite the small sample size. Complete cases analysis showed a statistically significant symptom reduction in depression, anxiety, disability, and post-traumatic stress, and statistically significant improvement in well-being and functioning. Intention-to-treat analysis revealed non-significant effects.

Conclusion

The research design, methods and procedures are feasible and acceptable in the context of Lebanon and can be applied in the RCTs. Preliminary findings suggest that Step-by-Step may be effective in reducing symptoms of depression and anxiety and improving functioning and well-being.

中文翻译：

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循序渐进：在黎巴嫩受逆境影响的人群中基于移动设备干预抑郁症的可行性随机对照试验

背景

电子心理健康干预措施可能有助于弥合心理健康治疗差距。在高收入国家，关于其有效性的证据令人信服。没有足够的证据表明它们在低收入和中等收入国家受逆境影响的社区中的使用。世界卫生组织 (WHO)、黎巴嫩公共卫生部 (MoPH) 的国家心理健康规划 (NMMP) 和其他合作伙伴已经调整了一项名为“循序渐进”的世卫组织干预措施，以供居住在黎巴嫩的黎巴嫩人和流离失所者使用. Step-by-Step 是针对患有抑郁症的成年人的最低限度指导、基于互联网的干预措施。本研究通过可行性随机对照试验（RCT）和定性过程评价，探讨研究方法的可行性和可接受性，以及干预措施，

方法

参与者是通过社交媒体招募的。纳入标准是：能够理解和说阿拉伯语或英语；访问互联网连接设备；18岁以上；住在黎巴嫩；患者健康问卷和世界卫生组织残疾评估表 2.0 的分数高于临界值。参与者像往常一样被随机分配到干预或加强护理。他们在基线后八周完成了后评估，并在三个月后完成了后续评估。主要结果是抑郁和功能水平，次要结果是焦虑、创伤后压力和幸福感。进行定性访谈以评估研究程序和干预措施的可行性和可接受性。

结果

总共招募了N  = 138 名参与者，其中包括 33 名叙利亚人，并随机分为两组。对照组的辍学率（73% 的事后评估和 82% 的后续评估）高于干预组（63% 的事后评估和 72% 的后续评估）。干预被认为对完成它的人是相关的、可接受的和有益的。提出了进一步调整内容并使干预更具吸引力的建议。尽管样本量很小，但仍进行了统计分析。完整病例分析显示，抑郁、焦虑、残疾和创伤后压力的症状在统计学上显着减少，幸福感和功能在统计学上显着改善。意向治疗分析显示无显着影响。

结论

研究设计、方法和程序在黎巴嫩背景下是可行和可接受的，可应用于 RCT。初步研究结果表明，循序渐进可能有效减轻抑郁和焦虑症状，改善功能和幸福感。