- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01054898
Effectiveness of a Telephone Intervention to Improve the Mental Health of Abused Women
May 26, 2015 updated by: Professor Agnes Tiwari, The University of Hong Kong
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hong Kong
-
Hong Kong, Hong Kong, China
- Hong Kong SKH Lady MacLehose Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Perpetrator is not an intimate partner
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: advocacy intervention
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
|
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
|
|
ACTIVE_COMPARATOR: Usual community services
Standard care for abused women in the community
|
standard care for abused women in the community
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
depression
Time Frame: On completion of intervention and six months post-intervention
|
On completion of intervention and six months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
perceived social support
Time Frame: On completion of intervention and six months post-intervention
|
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
|
On completion of intervention and six months post-intervention
|
|
intimate partner violence
Time Frame: On completion of intervention and six months post-intervention
|
On completion of intervention and six months post-intervention
|
|
safety behaviors
Time Frame: On completion of intervention and six months post-intervention
|
On completion of intervention and six months post-intervention
|
|
utilization of health services
Time Frame: On completion of intervention and six months post-intervention
|
On completion of intervention and six months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Tiwari 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (ACTUAL)
December 1, 2008
Study Completion (ACTUAL)
June 1, 2009
Study Registration Dates
First Submitted
January 20, 2010
First Submitted That Met QC Criteria
January 20, 2010
First Posted (ESTIMATE)
January 22, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
May 28, 2015
Last Update Submitted That Met QC Criteria
May 26, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UW 06-105 T/1130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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