Shrestha Rachana, Sapkota Diksha, Mehra Devika, Ekström Anna Mia, Deuba Keshab
Public Health and Environment Research Center, Lalitpur, Nepal.
Knowledge to Action, Lalitpur, Nepal.
JMIR Res Protoc. 2023 Aug 15;12:e45917. doi: 10.2196/45917.
Intimate partner violence (IPV) disproportionately affects people in low-and middle-income countries (LMICs), such as Nepal. Women experiencing IPV are at higher risk of developing depression, anxiety, and posttraumatic stress disorder. The shortage of trained frontline health care providers, coupled with stigma related to IPV and mental health disorders, fuels low service uptake among women experiencing IPV. The Domestic Violence Intervention (DeVI) combines the Problem Management Plus counseling program developed by the World Health Organization with a violence prevention component.
This study aims to implement and evaluate the feasibility, acceptability, and effectiveness of DeVI in addressing psychological distress and enabling the secondary prevention of violence for women experiencing IPV.
A parallel cluster-randomized trial will be conducted across 8 districts in Madhesh Province in Nepal, involving 24 health care facilities. The study will include women aged 18-49 years who are either nonpregnant or in their first trimester, have experienced IPV within the past 12 months, have a 12-item General Health Questionnaire (GHQ-12) score of 3 or more (indicating current mental health issues), and have lived with their husbands or in-laws for at least 6 months. A total sample size of 912 was estimated at 80% power and α<.05 statistical significance level to detect a 15% absolute risk reduction in the IPV frequency and a 50% reduction in the GHQ-12 score in the intervention arm. The health care facilities will be randomly assigned to either the intervention or the control arm in a 1:1 ratio. Women visiting the health care facilities in the intervention and control arms will be recruited into the respective arms. In total, 38 participants from each health care facility will be included in the trial to meet the desired sample size. Eligible participants allocated to either arm will be assessed at baseline and follow-up visits after 6, 17, and 52 weeks after baseline.
This study received funding in 2019. As of December 29, 2022, over 50% of eligible women had been recruited from both intervention and control sites. In total, 269 eligible women have been enrolled in the intervention arm and 309 eligible women in the control arm. The trial is currently in the recruitment phase. Data collection is expected to be completed by December 2023, after which data analysis will begin.
If the intervention proves effective, it will provide evidence of how nonspecialist mental health care providers can address the harmful effects of IPV in resource-constrained settings with a high burden of IPV, such as Nepal. The study findings could also contribute evidence for integrating similar services into routine health programs in LMICs to prevent IPV and manage mental health problems among women experiencing IPV.
ClinicalTrials.gov NCT05426863; https://clinicaltrials.gov/ct2/show/NCT05426863.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/45917.
亲密伴侣暴力（IPV）对尼泊尔等低收入和中等收入国家（LMICs）的人群影响尤为严重。遭受亲密伴侣暴力的女性患抑郁症、焦虑症和创伤后应激障碍的风险更高。训练有素的一线医疗服务提供者短缺，再加上与亲密伴侣暴力和精神健康障碍相关的污名化，导致遭受亲密伴侣暴力的女性很少寻求服务。家庭暴力干预（DeVI）项目将世界卫生组织开发的问题管理强化咨询项目与暴力预防内容相结合。
本研究旨在实施并评估家庭暴力干预项目在解决心理困扰以及对遭受亲密伴侣暴力的女性进行暴力二级预防方面的可行性、可接受性和有效性。
将在尼泊尔马德西省的8个地区开展一项平行整群随机试验，涉及24个医疗机构。研究对象为年龄在18至49岁之间、未怀孕或处于孕早期、在过去12个月内遭受过亲密伴侣暴力、12项一般健康问卷（GHQ - 12）得分在3分及以上（表明当前存在心理健康问题）且与丈夫或公婆共同生活至少6个月的女性。按照80%的检验效能和α<0.05的统计学显著性水平估计，总样本量为912，以检测干预组亲密伴侣暴力发生率绝对降低15%以及GHQ - 12得分降低50%。医疗机构将按1:1的比例随机分配到干预组或对照组。在干预组和对照组医疗机构就诊的女性将被纳入各自的组。每个医疗机构总共将有38名参与者纳入试验，以达到所需的样本量。分配到任何一组的符合条件的参与者将在基线以及基线后6周、17周和52周的随访中接受评估。
本研究于2019年获得资助。截至2022年12月29日，干预组和对照组均已有超过50%的符合条件的女性被招募。干预组共有269名符合条件的女性入组，对照组有309名符合条件的女性入组。该试验目前处于招募阶段。预计数据收集将于2023年12月完成，之后开始数据分析。
如果该干预措施被证明有效，将为非专科心理健康服务提供者如何在亲密伴侣暴力负担较高的资源受限环境（如尼泊尔）中应对亲密伴侣暴力的有害影响提供证据。研究结果还可为将类似服务纳入低收入和中等收入国家的常规卫生项目以预防亲密伴侣暴力并管理遭受亲密伴侣暴力女性的心理健康问题提供证据。
ClinicalTrials.gov NCT05426863；https://clinicaltrials.gov/ct2/show/NCT05426863。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/45917。
