Battered WomenNCT01054898
Effectiveness of a Telephone Intervention to Improve the Mental Health of Abused Women
A study testing advocacy intervention and usual community services in people with Battered Women, run by The University of Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to determine if a telephone social support and empowerment intervention is more effective than usual community services in improving the mental health of community-dwelling women abused by their intimate partners. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Battered Women
- What is being tested?
- advocacy intervention and usual community services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Feb 2007to Jun 2009
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese women 18 years of age or older
- Self-report of psychological, physical or sexual abuse by their current or former intimate partner in the previous 12 months
- Live or work in a community within the catchment area of a community centre designated for the proposed study
Who cannot join
- Perpetrator is not an intimate partner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RCT to Test the Effectiveness of a Telephone Intervention to Improve the Mental Health of Community Dwelling Women Abused by Their Intimate Partners
The purpose of this study is to determine if a telephone social support and empowerment intervention is more effective than usual community services in improving the mental health of community-dwelling women abused by their intimate partners.
Read the detailed description
Depression is one of the most common mental health sequelae of intimate partner violence (IPV). Although a range of interventions have been tried to improve the mental health of women survivors of IPV, the results are inconclusive. In this trial, a 12-week advocacy intervention consisting of empowerment and telephone social support is provided to abused Chinese women in a community setting. Usual community services provide the control condition.
- Conditions
- Battered Women
- Being tested
- advocacy intervention, usual community services
- Keywords
- depression, spouse abuse, intervention studies
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
advocacy interventionBehavioural
A 12-week telephone social support and empowerment intervention consisting of empowerment training, scheduled weekly telephone calls, and 24-hour access to a hotline for abused women
usual community servicesBehavioural
standard care for abused women in the community
| Study group | Role | What they receive |
|---|---|---|
| advocacy intervention | Experimental | A 12-week telephone social support and empowerment intervention consisting of empowerment training, scheduled weekly telephone calls, and 24-hour access to a hotline for abused women Receives: Behavioral: advocacy intervention |
| Usual community services | Active comparator | Standard care for abused women in the community Receives: Behavioral: usual community services |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression
Measured: On completion of intervention and six months post-intervention
Secondary outcomes (5)
perceived social support
Measured: On completion of intervention and six months post-intervention
health-related quality of life
Measured: On completion of intervention and six months post-intervention
intimate partner violence
Measured: On completion of intervention and six months post-intervention
safety behaviors
Measured: On completion of intervention and six months post-intervention
utilization of health services
Measured: On completion of intervention and six months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startFeb 2007
- Primary completionDec 2008
- Study completionJun 2009
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 Battered WomenStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Agnes Tiwari, The University of Hong Kong
- Investigators
- Agnes Tiwari, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054898
- Sponsor's protocol ID
- UW 06-105 T/1130
- Status last verified
- May 2015
- First submitted
- 20 Jan 2010
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tiwari A, Fong DY, Wong JY, Yuen KH, Yuk H, Pang P, Humphreys J, Bullock L. Safety-promoting behaviors of community-dwelling abused Chinese women after an advocacy intervention: a randomized controlled trial. Int J Nurs Stud. 2012 Jun;49(6):645-55. doi: 10.1016/j.ijnurstu.2011.12.005. Epub 2012 Jan 9.
PubMed 22227168Tiwari A, Fong DY, Yuen KH, Yuk H, Pang P, Humphreys J, Bullock L. Effect of an advocacy intervention on mental health in Chinese women survivors of intimate partner violence: a randomized controlled trial. JAMA. 2010 Aug 4;304(5):536-43. doi: 10.1001/jama.2010.1052.
PubMed 20682933
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RCT to Test the Effectiveness of a Telephone Intervention to Improve the Mental Health of Community Dwelling Women Abused by Their Intimate Partners
- ClinicalTrials.gov ID
- NCT01054898
- Acronym / sponsor ID
- UW 06-105 T/1130
- Conditions
- Battered Women
- Keywords
- depression, spouse abuse, intervention studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Jan 2010 (estimated)
- 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 purpose of this study is to determine if a telephone social support and empowerment intervention is more effective than usual community services in improving the mental health of community-dwelling women abused by their intimate partners.
Detailed description
Depression is one of the most common mental health sequelae of intimate partner violence (IPV). Although a range of interventions have been tried to improve the mental health of women survivors of IPV, the results are inconclusive. In this trial, a 12-week advocacy intervention consisting of empowerment and telephone social support is provided to abused Chinese women in a community setting. Usual community services provide the control condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| advocacy intervention | Experimental | Behavioral: advocacy interventionA 12-week telephone social support and empowerment intervention consisting of empowerment training, scheduled weekly telephone calls, and 24-hour access to a hotline for abused women |
| Usual community services | Active comparator | Behavioral: usual community servicesStandard care for abused women in the community |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chinese women 18 years of age or older
- Self-report of psychological, physical or sexual abuse by their current or former intimate partner in the previous 12 months
- Live or work in a community within the catchment area of a community centre designated for the proposed study
Key exclusion criteria (1 listed)
- Perpetrator is not an intimate partner
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 |
|---|---|---|
| advocacy interventionA 12-week telephone social support and empowerment intervention consisting of empowerment training, scheduled weekly telephone calls, and 24-hour access to a hotline for abused women | Behavioural | advocacy intervention |
| usual community servicesstandard care for abused women in the community | Behavioural | Usual community services |
Primary outcome
depression
Time frame: On completion of intervention and six months post-intervention
5 secondary outcomes
perceived social support
Time frame: On completion of intervention and six months post-intervention
health-related quality of life
Time frame: On completion of intervention and six months post-intervention
intimate partner violence
Time frame: On completion of intervention and six months post-intervention
safety behaviors
Time frame: On completion of intervention and six months post-intervention
utilization of health services
Time frame: On completion of intervention and six months post-intervention
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 28 May 2015.
- Derived from this study: PubMed 22227168Tiwari A, Fong DY, Wong JY, Yuen KH, Yuk H, Pang P, Humphreys J, Bullock L. Safety-promoting behaviors of community-dwelling abused Chinese women after an advocacy intervention: a randomized controlled trial. Int J Nurs Stud. 2012 Jun;49(6):645-55. doi: 10.1016/j.ijnurstu.2011.12.005. Epub 2012 Jan 9.
- Derived from this study: PubMed 20682933Tiwari A, Fong DY, Yuen KH, Yuk H, Pang P, Humphreys J, Bullock L. Effect of an advocacy intervention on mental health in Chinese women survivors of intimate partner violence: a randomized controlled trial. JAMA. 2010 Aug 4;304(5):536-43. doi: 10.1001/jama.2010.1052.
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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.
Agnes Tiwari, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing advocacy intervention and usual community services in people with Battered Women, run by The University of Hong Kong at 1 site in China.
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 3 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 28 May 2015. 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 China. 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?
depression (time frame: On completion of intervention and six months post-intervention). 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 NCT01054898, 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 28 May 2015.