Domestic Violence Intervention to Reduce Psychological Distress and Violence Among Women Experiencing IPV in Nepal

NCT ID: NCT05426863

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

912 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-08

Study Completion Date

2024-02-22

Brief Summary

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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

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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.

Conditions

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Intimate Partner Violence Domestic Violence Intervention Mental Health Secondary Prevention Problem Management Plus Cluster Randomized Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Psychosocial Counselling

A multi-component intervention counseling package to prevent the reoccurrence of IPV and address psychological distress among women experiencing violence. The DeVI intervention is structured into five weekly sessions.

Group Type EXPERIMENTAL

DeVI

Intervention Type BEHAVIORAL

A multi-component intervention is devised from the components of PM+ developed by WHO incorporating the components of violence prevention. The intervention is anticipated to provide behavioral skills to the participants in the intervention arm which will enhance their coping skills with past experiences of violence, stress management skills, problem-solving skills and safety planning skills. Further, they will be shared the best practices and lessons learned which will aid in danger assessments and prevention of future violence. The intervention will be given to intervention arm in 5 different sessions, one in each week. The 1st session of the intervention is about understanding the multi-component intervention. The 2nd session is identifying and managing problem, 3rd session is about stress management, followed by development of safety plan in 4th session and last session is about promotion of social support.

Standard Usual Care

Provide standard usual care and information booklet similar to that of the intervention group that contains updated contact information for the referral services.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DeVI

A multi-component intervention is devised from the components of PM+ developed by WHO incorporating the components of violence prevention. The intervention is anticipated to provide behavioral skills to the participants in the intervention arm which will enhance their coping skills with past experiences of violence, stress management skills, problem-solving skills and safety planning skills. Further, they will be shared the best practices and lessons learned which will aid in danger assessments and prevention of future violence. The intervention will be given to intervention arm in 5 different sessions, one in each week. The 1st session of the intervention is about understanding the multi-component intervention. The 2nd session is identifying and managing problem, 3rd session is about stress management, followed by development of safety plan in 4th session and last session is about promotion of social support.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Global and Sexual Health (GloSH)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keshab Deuba, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Instituet

Locations

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DeVI Intervention Site

Janakpur Dham, Madhesh, Nepal

Site Status

Countries

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Nepal

References

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Shrestha R, Sapkota D, Mehra D, Ekstrom AM, Deuba K. Feasibility and Effectiveness of an Intervention to Reduce Intimate Partner Violence and Psychological Distress Among Women in Nepal: Protocol for the Domestic Violence Intervention (DeVI) Cluster-Randomized Trial. JMIR Res Protoc. 2023 Aug 15;12:e45917. doi: 10.2196/45917.

Reference Type DERIVED
PMID: 37581909 (View on PubMed)

Other Identifiers

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555

Identifier Type: -

Identifier Source: org_study_id

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