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

NCT05426863 | Completed DMC

• 1 other identifier: 555
• Study Type: interventional
• Target: 912
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• General Health Questionnaire (GHQ-12)

  12 item measures for psychological disorders in non-clinical settings, minimum value=0 maximum value=12; higher scores mean greater distress

  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)

• Intimate partner violence or domestic violence

  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."

  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 (11)

• 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)

• Perceived Social Support

  Baseline(T1), 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)

Other Outcomes (1)

• Exit Client Interview

  at 1 week post-intervention assessment (T2)

Study Arms (2)

Psychosocial Counselling

EXPERIMENTAL

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.

Behavioral: DeVI

Standard Usual Care

NO INTERVENTION

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

Interventions

DeVI 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.

Psychosocial Counselling

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Global and Sexual Health (GloSH): lead

Study Sites (1)

DeVI Intervention Site

Janakpur Dham, Madhesh, Nepal

Location

Related Publications (1)

• 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.

  PMID: 37581909 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Keshab Deuba, PhD

  Karolinska Instituet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 22, 2022
• Study Start: June 8, 2022
• Primary Completion: July 7, 2023
• Study Completion: February 22, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Materials will be shared after publication of primary results.
• Access Criteria: Contact PI.

Locations

NE (1)