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

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mental Health; Domestic Violence; Intimate Partner Violence; Intervention; Secondary Prevention; Problem Management Plus; Cluster Randomized Trial
• Intervention / Treatment: Behavioral: DeVI

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.

• Study Type: Interventional
• Enrollment (Estimated): 912
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachana Shrestha, MPH; Phone Number: 977-9860999428; Email: rachanashrestha2@gmail.com
• Study Contact Backup: Name: Anna Mia Ekstrom, PhD; Phone Number: +46-(0)73-6274884; Email: anna.mia.ekstrom@ki.se

Study Locations

• Nepal
  • Madhesh
    • Janakpur, Madhesh, Nepal
      • DeVI Intervention Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9)	9-item measure of depression symptoms; minimum value = 0, maximum value = 27; higher scores mean more severe depression symptoms support, impaired functioning, symptoms of post-traumatic stress, personally identified problems, and health service utilization.	Baseline(T1),6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
Post-traumatic stress Disorder (PTSD)-(PCL-C)	17-item measure of Post-traumatic stress disorder; minimum value=17 maximum value=85. The 17-29=little to No PTSD symptoms, 28-29=some PTSD symptoms, 30-44=moderate severity of PTSD symptoms and 45-85 =high severity of PTSD symptoms.	Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
The Hospital Anxiety and Depression Scale (HADS)	Measure of anxiety disorders and depression; minimum value=0 maximum value=21. 7 or less indicate non anxiety and non-depression cases, 8 to 10 indicates borderline cases, 11 and above indicates definite cases.	Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
Perceived Social Support	5-items measures of support received from the community; minimum value=5 (less perceived support) maximum value=25(higher perceived support)	Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
WHO Disability Assessment Schedule (WHODAS 2.0)	12-items measure of difficulties of individual in performing the certain activities; minimum value=0 maximum value=48	Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
PSYCHLOPS	Measures of the problem and its effect in wellbeing and daily functioning over the last week; minimum value=0 maximum value=20 higher score denotes higher severity of psychological stress and functioning.	Baseline(T1), during intervention (in intervention arm only), 6 weeks after Baseline(T2), 17 weeks after Baseline (T3)
Safety Behaviour Checklist and Use of Community Resource	Measure the safety measures adopted by the participants in advance of potentially dangerous situations; the utilization of the local services available in the community for the prevention or the reduction of the violence occurrence	Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3), 52 weeks after Baseline (T4)
Modified Physical Readiness to Manage IPV Survey (PREMIS)	7-items measures of actual IPV knowledge, 23-items measures of attitude towards IPV, and 10-items measures of practice issues. All these items will be presented in descriptive format i.e. frequency and percentage of each option of each question selected by participants.	Immediately after Integrated multi component Intervention Training (10 days post -baseline), during Integrated multicomponent supervision (approximately 90-days post-baseline)
Mental Health knowledge Schedule (MAKS)	MAKS consists of six stigma-related mental health knowledge areas; employment, recognition, treatment, supports, help-seeking and recovery and knowledge and mental health conditions. MAKS comprises 12 items; among which 4 are negative statements. Each item has 5 points Likert scale score ranging from 1-5. For the positive statement, 'Strongly Agree' scores the highest 5 points, whereas 'Strongly Disagree' scores 1. The points in the ordinal scale are reversed for the negative statements. The totals score is calculated summing up the score of each of the 12 items. Higher score indicates higher participant's knowledge on mental health. We will document the change in the mean scores of mental health literacy between the two arms measured using MAKS.	Immediately after Integrated multi component Intervention Training (10 days post -baseline, during Integrated multicomponent supervision (approximately 90-days post-baseline)
Social Distance Scale	Social Distance Scale is aimed for the healthcare providers to measure their attitude towards the people with mental health. It is 7-item scale consisting 4 points scale each item ranging between 0-3, where 0 = definitely willing, 1= willing, 2= unwilling and 3 = definitely unwilling. Possible scores thus range from 0 to 21, with higher scores representing a greater desire to distance oneself from persons who have mental illness.	Immediately after Integrated multi component Intervention Training (10 days post -baseline)
Perceived Dangerousness of the Mental Health Patients	Perceived Dangerousness scale measures will be used to assess the perceived perceptions of health workers towards mental health patients. The scale consists of 8 items and responses on each item were measured using a six-point scale 0-5; ranging from strongly agree-strongly disagree. Majority of the statements are negative with reversed options order. The total score ranges from 0-40. The score will be obtained in each item by summing up to obtain a total score, which is divided by eight to create a scale varying from 0-5. The high score reflects the belief / perception that the people with mental illness are dangerous.	Immediately after Integrated multi component Intervention Training (10 days post -baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exit Client Interview	Exit client interview will be used to measure satisfaction and acceptability of the intervention from the participant's point of view in the intervention arm. A total of 15 mixed qualitative and quantitative questions will be used. Quantitative questions ranges from 0-17, higher scores means both satisfied and accepted intervention while lower score means not satisfied and not accepted the intervention. In addition qualitative question will be asked to understand and know more about the satisfaction and acceptability of intervention among the participants.	at 1 week post-intervention assessment (T2)

Collaborators and Investigators

• Sponsor: Global and Sexual Health (GloSH)
• Investigators: Principal Investigator: Keshab Deuba, PhD, Karolinska Instituet

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Estimated): June 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 555

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual data will be available through K2A Data Archive after publication of primary results.
• IPD Sharing Time Frame: Materials will be shared after publication of primary results.
• IPD Sharing Access Criteria: Contact PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No