Domestic ViolenceNCT03469739
Types of Intimate Partner Violence and Women's Health
An observational study of Domestic Violence, run by University of Bristol.
Trial summary
This study uses data from 29,990 women from 12 different countries collected by the WHO multi-country study on women's health and domestic violence to capture the effect of different types, frequency and timing of IPV on self-reported health, symptoms and suicidal behaviours. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- How many people
- 29,990 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Aug 2017
- Phase
- Observational
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: This study consists of further analysis of 29,990 interviews conducted with women in 12 different countries coordinated by the World Health Organisation. They report in most sites around 1500 women between 15 and 49 years old were interviewed. Countries included were Bangladesh, Brazil, Cambodia, Ethiopia, Japan, Maldives, Namibia, Peru, Samoa, Serbia and Montenegro, Thailand and the United Republic of Tanzania.
Who may be able to join
- The WHO report that in most sites, a representative sample of women was obtained using a two-stage cluster sampling scheme to select households and then only one woman per household was randomly selected per household for interview.
Who cannot join
- -
About this study
Official title: Types of Intimate Partner Violence and Women's Health: Findings From the WHO Multi-country Study on Women's Health and Intimate Partner Violence
This study uses data from 29,990 women from 12 different countries collected by the WHO multi-country study on women's health and domestic violence to capture the effect of different types, frequency and timing of IPV on self-reported health, symptoms and suicidal behaviours.
Read the detailed description
Intimate partner violence (IPV) has detrimental effects on physical and mental health, risks to children and is associated with wider societal and healthcare costs. Previous analysis of the WHO multi-country study on women's health and domestic violence found significant associations between physical and sexual IPV and self-reported ill-health, symptomatology and suicidal behaviours.
Real experience of IPV can comprise different combinations of emotional, physical and sexual abuse, and different timings and frequencies of these. A more nuanced testing of exposure to these different combinations of IPV and associations with health is needed.
This study uses data from 29,990 women from 12 different countries collected by the WHO multi-country study on women's health and domestic violence to capture the effect of different combination types, frequency and timing of IPV on self-reported health, symptoms and suicidal behaviours.
- Conditions
- Domestic Violence
- Keywords
- Intimate Partner Violence
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant description of their current overall state of health
Participant description of their current overall state of health- a choice of options- excellent, good, fair, poor or very poor.
Measured: Preceding 4 weeks
Secondary outcomes (4)
Participant reported health in the last 4 weeks- problems walking around, doing usual activities, pain or discomfort, problems with memory or concentration, dizziness or vaginal discharge. Measured by questionnaire.
Participant rating of various health aspects in last 4 weeks
Measured: Preceding 4 weeks
Emotional distress. Measured by questionnaire of 20 different symptoms of emotional distress. SRQ-20 (score of 20 different symptoms of emotional distress with yes/no answers)
Self Reporting Questionnaire-20 (SRQ-20)- aggregate score of 20 different symptoms of emotional distress with yes/no answers
Measured: Preceding 4 weeks
Participant reported ever suicidal thoughts or attempts; measured by questionnaire.
Participants reporting ever having suicidal thoughts or ever attempting suicide
Measured: Up to 49 years
Participant reported medication used for sleep/ pain; measured by questionnaire.
Participants reporting medication use
Measured: Preceding 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study startJun 2016
- Primary completionAug 2017
- Study completionAug 2017
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 Domestic 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 29,990 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bristol
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gene Feder, MD FRCGP, Study director, University of BristolLucy C Potter, MB ChB, Principal investigator, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469739
- Sponsor's protocol ID
- UoB2646
- Status last verified
- Jan 2018
- First submitted
- 10 Jun 2016
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ellsberg M, Jansen HA, Heise L, Watts CH, Garcia-Moreno C; WHO Multi-country Study on Women's Health and Domestic Violence against Women Study Team. Intimate partner violence and women's physical and mental health in the WHO multi-country study on women's health and domestic violence: an observational study. Lancet. 2008 Apr 5;371(9619):1165-72. doi: 10.1016/S0140-6736(08)60522-X.
PubMed 18395577Garcia-Moreno C, Jansen HA, Ellsberg M, Heise L, Watts CH; WHO Multi-country Study on Women's Health and Domestic Violence against Women Study Team. Prevalence of intimate partner violence: findings from the WHO multi-country study on women's health and domestic violence. Lancet. 2006 Oct 7;368(9543):1260-9. doi: 10.1016/S0140-6736(06)69523-8.
PubMed 17027732
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Types of Intimate Partner Violence and Women's Health: Findings From the WHO Multi-country Study on Women's Health and Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT03469739
- Acronym / sponsor ID
- UoB2646
- Conditions
- Domestic Violence
- Keywords
- Intimate Partner Violence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29,990 participants (actual)
- Lead sponsor
- University of BristolUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 19 Mar 2018 (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.
This study uses data from 29,990 women from 12 different countries collected by the WHO multi-country study on women's health and domestic violence to capture the effect of different types, frequency and timing of IPV on self-reported health, symptoms and suicidal behaviours.
Detailed description
Intimate partner violence (IPV) has detrimental effects on physical and mental health, risks to children and is associated with wider societal and healthcare costs. Previous analysis of the WHO multi-country study on women's health and domestic violence found significant associations between physical and sexual IPV and self-reported ill-health, symptomatology and suicidal behaviours.
Real experience of IPV can comprise different combinations of emotional, physical and sexual abuse, and different timings and frequencies of these. A more nuanced testing of exposure to these different combinations of IPV and associations with health is needed.
This study uses data from 29,990 women from 12 different countries collected by the WHO multi-country study on women's health and domestic violence to capture the effect of different combination types, frequency and timing of IPV on self-reported health, symptoms and suicidal behaviours.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This study consists of further analysis of 29,990 interviews conducted with women in 12 different countries coordinated by the World Health Organisation. They report in most sites around 1500 women between 15 and 49 years old were interviewed. Countries included were Bangladesh, Brazil, Cambodia, Ethiopia, Japan, Maldives, Namibia, Peru, Samoa, Serbia and Montenegro, Thailand and the United Republic of Tanzania.
Key inclusion criteria (1 listed)
- The WHO report that in most sites, a representative sample of women was obtained using a two-stage cluster sampling scheme to select households and then only one woman per household was randomly selected per household for interview.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participant description of their current overall state of health
Time frame: Preceding 4 weeks
Participant description of their current overall state of health- a choice of options- excellent, good, fair, poor or very poor.
4 secondary outcomes
Participant reported health in the last 4 weeks- problems walking around, doing usual activities, pain or discomfort, problems with memory or concentration, dizziness or vaginal discharge. Measured by questionnaire.
Time frame: Preceding 4 weeks
Emotional distress. Measured by questionnaire of 20 different symptoms of emotional distress. SRQ-20 (score of 20 different symptoms of emotional distress with yes/no answers)
Time frame: Preceding 4 weeks
Participant reported ever suicidal thoughts or attempts; measured by questionnaire.
Time frame: Up to 49 years
Participant reported medication used for sleep/ pain; measured by questionnaire.
Time frame: Preceding 4 weeks
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 19 Mar 2018.
- Background: PubMed 18395577Ellsberg M, Jansen HA, Heise L, Watts CH, Garcia-Moreno C; WHO Multi-country Study on Women's Health and Domestic Violence against Women Study Team. Intimate partner violence and women's physical and mental health in the WHO multi-country study on women's health and domestic violence: an observational study. Lancet. 2008 Apr 5;371(9619):1165-72. doi: 10.1016/S0140-6736(08)60522-X.
- Background: PubMed 17027732Garcia-Moreno C, Jansen HA, Ellsberg M, Heise L, Watts CH; WHO Multi-country Study on Women's Health and Domestic Violence against Women Study Team. Prevalence of intimate partner violence: findings from the WHO multi-country study on women's health and domestic violence. Lancet. 2006 Oct 7;368(9543):1260-9. doi: 10.1016/S0140-6736(06)69523-8.
- Individual participant dataSharing planned: No
Related trials for Domestic Violence
RecruitingObservational study
Self-Dehumanization and Hesitation to Report Domestic Violence
Domestic Violence
Active, not recruiting
Community Resiliency Collective Efficacy Intervention
Violence, Physical, Violence, Non-accidental
Enrolling by invitation
Evaluation of a Trauma-Informed Partner Violence Intervention Program
Domestic Violence, Post Traumatic Stress Disorder
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
Intimate Partner Violence, Personality Disorders
RecruitingObservational study
Evaluation of the Impact on Mental and Physical Health of Caring for Women Who Are Victims of Sexual and Gender-based Violence, Using a Coordinated Multidisciplinary Approach in Women's Centres or Traditional Health Centres.
Domestic and/or Sexual Violence
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.
Gene Feder, MD FRCGP study director
University of Bristol
Lucy C Potter, MB ChB principal investigator
University of Bristol
Questions about this trial
What is this clinical trial studying?
An observational study of Domestic Violence, run by University of Bristol.
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 1 inclusion and 1 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 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Participant description of their current overall state of health (time frame: Preceding 4 weeks). 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 NCT03469739, 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 19 Mar 2018.