Clinical trial NCT05426863: Domestic Violence Intervention to Reduce Psychological Distress and Violence Among Women Experiencing IPV in Nepal
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intimate Partner Violence
Domestic Violence
Intervention
Mental Health
Secondary Prevention
Problem Management Plus
Cluster Randomized Trial
Lead sponsor: Global and Sexual Health (GloSH)
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 912
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

1. 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.
2. To train non-specialist mental health care providers on the delivery of DeVI among women exposed to IPV.
3. To explore participants' and health care providers' experiences with DeVI Intervention and the opportunities and challenges encountered during implementation.
4. 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.
5. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Have a severe cognitive impairment
* Seeking treatment for life-threatening emergency care
* Have suicidal thoughts

Primary outcomes:
measure: General Health Questionnaire (GHQ-12)
timeFrame: 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)
measure: Intimate partner violence or domestic violence
timeFrame: 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)
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline(T1),6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
measure: Post-traumatic stress Disorder (PTSD)-(PCL-C)
timeFrame: Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
measure: The Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
measure: Perceived Social Support
timeFrame: Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
measure: WHO Disability Assessment Schedule (WHODAS 2.0)
timeFrame: Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
measure: PSYCHLOPS
timeFrame: Baseline(T1), during intervention (in intervention arm only), 6 weeks after Baseline(T2), 17 weeks after Baseline (T3)
measure: Safety Behaviour Checklist and Use of Community Resource
timeFrame: Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3), 52 weeks after Baseline (T4)
measure: Modified Physical Readiness to Manage IPV Survey (PREMIS)
timeFrame: Immediately after Integrated multi component Intervention Training (10 days post -baseline), during Integrated multicomponent supervision (approximately 90-days post-baseline)
measure: Mental Health knowledge Schedule (MAKS)
timeFrame: Immediately after Integrated multi component Intervention Training (10 days post -baseline, during Integrated multicomponent supervision (approximately 90-days post-baseline)
measure: Social Distance Scale
timeFrame: Immediately after Integrated multi component Intervention Training (10 days post -baseline)
measure: Perceived Dangerousness of the Mental Health Patients
timeFrame: Immediately after Integrated multi component Intervention Training (10 days post -baseline)
Other outcomes:
measure: Exit Client Interview
timeFrame: at 1 week post-intervention assessment (T2)
Locations:
city: Janakpur
country: Nepal
facility: DeVI Intervention Site
state: Madhesh
Study officials:
affiliation: Karolinska Instituet
name: Keshab Deuba, PhD
role: PRINCIPAL_INVESTIGATOR
References: