ImportanceMore than 150 million people in India need mental health care but few have access to affordable care, especially in rural areas.ObjectiveTo determine whether a multifaceted intervention involving a digital health care model along with a community-based antistigma campaign leads to reduced depression risk and lower mental health–related stigma among adults residing in rural India.Design, Setting, and ParticipantsThis parallel, cluster randomized, usual care–controlled trial was conducted from September 2020 to December 2021 with blinded follow-up assessments at 3, 6, and 12 months at 44 rural primary health centers across 3 districts in Haryana and Andhra Pradesh states in India. Adults aged 18 years and older at high risk of depression or self-harm defined by either a Patient Health Questionnaire–9 item (PHQ-9) score of 10 or greater, a Generalized Anxiety Disorder–7 item (GAD-7) score of 10 or greater, or a score of 2 or greater on the self-harm/suicide risk question on the PHQ-9. A second cohort of adults not at high risk were selected randomly from the remaining screened population. Data were cleaned and analyzed from April 2022 to February 2023.InterventionsThe 12-month intervention included a community-based antistigma campaign involving all participants and a digital mental health intervention involving only participants at high risk. Primary health care workers were trained to identify and manage participants at high risk using the Mental Health Gap Action Programme guidelines from the World Health Organization.Main Outcomes and MeasuresThe 2 coprimary outcomes assessed at 12 months were mean PHQ-9 scores in the high-risk cohort and mean behavior scores in the combined high-risk and non–high-risk cohorts using the Mental Health Knowledge, Attitude, and Behavior scale.ResultsAltogether, 9928 participants were recruited (3365 at high risk and 6563 not at high risk; 5638 [57%] female and 4290 [43%] male; mean [SD] age, 43 [16] years) with 9057 (91.2%) followed up at 12 months. Mean PHQ-9 scores at 12 months for the high-risk cohort were lower in the intervention vs control groups (2.77 vs 4.48; mean difference, −1.71; 95% CI, −2.53 to −0.89; P < .001). The remission rate in the high-risk cohort (PHQ-9 and GAD-7 scores <5 and no risk of self-harm) was higher in the intervention vs control group (74.7% vs 50.6%; odds ratio [OR], 2.88; 95% CI, 1.53 to 5.42; P = .001). Across both cohorts, there was no difference in 12-month behavior scores in the intervention vs control group (17.39 vs 17.74; mean difference, −0.35; 95% CI, −1.11 to 0.41; P = .36).Conclusions and RelevanceA multifaceted intervention was effective in reducing depression risk but did not improve intended help-seeking behaviors for mental illness.Trial RegistrationClinical Trial Registry India: CTRI/2018/08/015355.

中文翻译：

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印度农村地区的心理保健支持


重要性 印度有超过 1.5 亿人需要精神卫生保健，但很少有人能够获得负担得起的护理，特别是在农村地区。 目的 确定涉及数字医疗保健模式和基于社区的反耻辱运动的多方面干预措施是否可以降低抑郁风险和居住在印度农村的成年人中与心理健康相关的耻辱感较低。 设计、环境和参与者这项平行、整群随机、常规护理对照试验于 2020 年 9 月至 2021 年 12 月进行，并在 3、6 和 12 日进行盲法随访评估在印度哈里亚纳邦和安得拉邦 3 个地区的 44 个农村初级卫生中心进行了数月的研究。 18 岁及以上患有抑郁症或自残高风险的成年人，其定义为患者健康问卷 - 9 项目 (PHQ-9) 得分为 10 或更高，广泛性焦虑症 - 7 项目 (GAD-7) 得分为 10 或更高PHQ-9 上的自残/自杀风险问题得分为 10 或更高，或者得分为 2 或更高。从剩余的筛查人群中随机选择第二组非高危成年人。从 2022 年 4 月到 2023 年 2 月对数据进行清理和分析。 干预措施 为期 12 个月的干预措施包括一项涉及所有参与者的基于社区的反耻辱运动和一项仅涉及高风险参与者的数字心理健康干预措施。初级卫生保健工作者接受了培训，可以使用世界卫生组织的心理健康差距行动计划指南来识别和管理高风险参与者。主要结果和测量 12 个月时评估的 2 个共同主要结果是高风险队列中的平均 PHQ-9 分数以及使用心理健康知识、态度和行为的高风险和非高风险队列中的平均行为分数结果总共招募了 9928 名参与者（3365 名高风险参与者和 6563 名非高风险参与者；5638 名女性 [57%] 和 4290 名男性 [43%]；平均 [SD] 年龄 43 [16] 岁），其中 9057 名参与者 (91.2 %) 12 个月后进行随访。与对照组相比，高危人群 12 个月时的平均 PHQ-9 评分较低（2.77 vs 4.48；平均差，-1.71；95% CI，-2.53 至 -0.89；P < .001）。高风险队列（PHQ-9 和 GAD-7 评分 <5，无自残风险）的缓解率在干预组中高于对照组（74.7% vs 50.6%；比值比 [OR]， 2.88；95% CI，1.53 至 5.42；P = .001）。在这两个队列中，干预组与对照组的 12 个月行为评分没有差异（17.39 vs 17.74；平均差，-0.35；95% CI，-1.11 至 0.41；P = .36）。 结论和相关性A 多方面的干预可有效降低抑郁风险，但无法改善精神疾病的预期求助行为。试验注册印度临床试验注册处：CTRI/2018/08/015355。