Integrated Multicomponent Intervention for Violence Prevention and Management of Mental Health Problems Among Women Experiencing IPV in Madhesh Province of Nepal: A Cluster Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 912
- 试验地点
- 1
- 主要终点
- General Health Questionnaire (GHQ-12)
研究概览
简要总结
The aim of this study is to implement and evaluate the feasibility, acceptability, and effectiveness of a validated integrated multi-component intervention targeting secondary prevention of violence and addressing the mental health needs of women experiencing intimate partner violence.
详细描述
This study's aim is to assess the feasibility and effectiveness of an integrated multicomponent intervention among women experiencing violence in Madhesh Province of Nepal.
- To assess the feasibility of DeVI in health care centers in Nepal by exploring the views of key stakeholders, health care providers, and local women in the community.
- To train non-specialist mental health care providers on the delivery of DeVI among women exposed to IPV.
- To explore participants' and health care providers' experiences with DeVI Intervention and the opportunities and challenges encountered during implementation.
- To measure the effectiveness of the DeVI intervention in addressing psychological distress, reducing the occurrence of IPV, and developing safety strategies among women experiencing IPV.
- To measure the impact of the DeVI training on knowledge, attitudes, skills, and stigma towards IPV and its consequences, particularly on psychological trauma among health care providers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the age of 18-49 years
- •Having experienced abuse (physical, sexual, or psychological) in a heterosexual relationship from her husband or her family members in the last 12 months
- •Non-pregnant or pregnant in the first trimester
- •Score of 3 and above in the psychological distress scale (measured by General Health Questionnaire (GHQ-12))
- •Living with her husband or in-laws for at least six months.
排除标准
- •Have a severe cognitive impairment
- •Seeking treatment for life-threatening emergency care
- •Have suicidal thoughts
结局指标
主要结局
General Health Questionnaire (GHQ-12)
时间窗: Baseline Assessment (T1); Changes from Baseline assessment, at 1 week post-intervention assessment (6 weeks after Baseline) (T2), Changes from Baseline assessment, at 12 week post-intervention assessment (17 weeks after Baseline) (T3)
12 item measures for psychological disorders in non-clinical settings, minimum value=0 maximum value=12; higher scores mean greater distress
Intimate partner violence or domestic violence
时间窗: Baseline(T1),Changes from Baseline, at 1 week post-intervention(6 weeks after Baseline)(T2),change from baseline, at 12 week post-intervention(17 weeks after Baseline) (T3),Changes from Baseline,at 47 week post intervention(52 weeks after baseline) (T4)
We will document the change in the experience of IPV or domestic violence using modified WHO multi country questionnaire. Defined as violence in the different time frame with participants' husband/male partner/ in-law's. a) Controlling behaviors: "presence of at least one behavior (restrict contact with participants family of birth, ignore participants and treat indifferently etc.)". b) Psychological violence: "insulted participants to made participant's feel bad about herself, belittled or humiliated you in front of other people, yelling and smashing things to scare participants, threat to hurt participants or her close one". c) Physical violence: "slapped, pushed or pulled; hit with fist or something else; kicked, dragged or beating; choked or burnt on purpose; threatened with gun, knife or other weapon". d) Sexual violence: "physically forced participants to have sexual intercourse; forced to do something sexual that is degrading or humiliating etc."
次要结局
- PSYCHLOPS(Baseline(T1), during intervention (in intervention arm only), 6 weeks after Baseline(T2), 17 weeks after Baseline (T3))
- WHO Disability Assessment Schedule (WHODAS 2.0)(Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3))
- Perceived Social Support(Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3))
- Safety Behaviour Checklist and Use of Community Resource(Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3), 52 weeks after Baseline (T4))
- Mental Health knowledge Schedule (MAKS)(Immediately after Integrated multi component Intervention Training (10 days post -baseline, during Integrated multicomponent supervision (approximately 90-days post-baseline))
- Patient Health Questionnaire (PHQ-9)(Baseline(T1),6 weeks after Baseline(T2), 17 weeks after Baseline(T3))
- Post-traumatic stress Disorder (PTSD)-(PCL-C)(Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3))
- The Hospital Anxiety and Depression Scale (HADS)(Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3))
- Modified Physical Readiness to Manage IPV Survey (PREMIS)(Immediately after Integrated multi component Intervention Training (10 days post -baseline), during Integrated multicomponent supervision (approximately 90-days post-baseline))
- Social Distance Scale(Immediately after Integrated multi component Intervention Training (10 days post -baseline))
- Perceived Dangerousness of the Mental Health Patients(Immediately after Integrated multi component Intervention Training (10 days post -baseline))