Intimate Partner ViolenceDeVINCT05426863
Domestic Violence Intervention to Reduce Psychological Distress and Violence Among Women Experiencing IPV in Nepal
A study testing DeVI in people with Intimate Partner Violence and Domestic Violence, run by Global and Sexual Health (GloSH) at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Intimate Partner Violence, Domestic Violence, Intervention
- What is being tested?
- DeVI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 912 participants
- Where
- 1 siteNepal
- Study dates
- 8 Jun 2022to 22 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Have a severe cognitive impairment
- Seeking treatment for life-threatening emergency care
- Have suicidal thoughts
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- 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.
- Conditions
- Intimate Partner Violence, Domestic Violence, Intervention, Mental Health, Secondary Prevention, Problem Management Plus
- Being tested
- DeVI
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeVIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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."
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after Integrated multi component Intervention Training (10 days post -baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start8 Jun 2022
- Primary completion7 Jul 2023
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global and Sexual Health (GloSH)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keshab Deuba, PhD, Principal investigator, Karolinska Instituet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426863
- Sponsor's protocol ID
- 555
- Acronym
- DeVI
- Status last verified
- Aug 2025
- First submitted
- 8 Jun 2022
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data will be available through K2A Data Archive after publication of primary results.
Publications
Koju R, Shrestha R, Dhungana J, Lamichhane A, Sapkota D, Ekstrom AM, Deuba K. Strengthening Nonspecialist Health Care Providers' Capacity to Address Mental Health in the Context of Domestic Violence in Nepal: Pre-Post Mixed Methods Training Evaluation. JMIR Form Res. 2026 Feb 12;10:e72793. doi: 10.2196/72793.
PubMed 41678790Shrestha 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.
PubMed 37581909
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05426863
- Acronym / sponsor ID
- DeVI / 555
- Conditions
- Intimate Partner Violence, Domestic Violence, Intervention, Mental Health, Secondary Prevention, Problem Management Plus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 912 participants (actual)
- Lead sponsor
- Global and Sexual Health (GloSH)University, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial Counselling | Experimental | Behavioral: DeVIA 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. |
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Have a severe cognitive impairment
- Seeking treatment for life-threatening emergency care
- Have suicidal thoughts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeVIA 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. | Behavioural | Psychosocial Counselling |
Primary outcome
General Health Questionnaire (GHQ-12)
Time frame: 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
Time frame: 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."
11 secondary outcomes
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline(T1),6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
Post-traumatic stress Disorder (PTSD)-(PCL-C)
Time frame: Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
The Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
Perceived Social Support
Time frame: Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
WHO Disability Assessment Schedule (WHODAS 2.0)
Time frame: Baseline(T1), 6 weeks after Baseline(T2), 17 weeks after Baseline(T3)
PSYCHLOPS
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Immediately after Integrated multi component Intervention Training (10 days post -baseline, during Integrated multicomponent supervision (approximately 90-days post-baseline)
Social Distance Scale
Time frame: Immediately after Integrated multi component Intervention Training (10 days post -baseline)
Perceived Dangerousness of the Mental Health Patients
Time frame: Immediately after Integrated multi component Intervention Training (10 days post -baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Derived from this study: PubMed 41678790Koju R, Shrestha R, Dhungana J, Lamichhane A, Sapkota D, Ekstrom AM, Deuba K. Strengthening Nonspecialist Health Care Providers' Capacity to Address Mental Health in the Context of Domestic Violence in Nepal: Pre-Post Mixed Methods Training Evaluation. JMIR Form Res. 2026 Feb 12;10:e72793. doi: 10.2196/72793.
- Derived from this study: PubMed 37581909Shrestha 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.
- Individual participant dataSharing planned: Yes. De-identified individual data will be available through K2A Data Archive after publication of primary results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keshab Deuba, PhD principal investigator
Karolinska Instituet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DeVI in people with Intimate Partner Violence and Domestic Violence, run by Global and Sexual Health (GloSH) at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Health Questionnaire (GHQ-12) (time frame: 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05426863, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.