- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00457522
Telephone Intervention to Increase Safety in Abused Women
January 16, 2018 updated by: Johns Hopkins University
Phone Intervention to Increase Safety in Abused Women: Pilot
Although abuse by an intimate partner is very common and has serious negative effects on women's health, few studies have been done to test ways to increase safety for women in abusive relationships. This study will test a telephone intervention for women who report physical, emotional, and/or sexual abuse within the past 12 months, to see if
- women use more safety behaviors and access more community resources
- chronic pain, fatigue, depressive, and post-traumatic stress disorder (PTSD) symptoms affect a women's ability to use safety behaviors and access community resources.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Women who experience intimate partner violence (IPV) are at increased risk for serious long term negative health sequelae, injury, and death.
Compared to non-abused women, intimately abused women suffer significantly greater prevalence of depression and post-traumatic stress disorder (PTSD), as well as a host of nonspecific physical symptoms including chronic pain and fatigue (Campbell, 2002; Golding, 1999; Asmundson, Coons, Taylor, & Katz, 2002; Ehlert, Gaab, & Heinrichs, 2001; Green, Baker, Sato, Washington, & Smith, 2003; Woods, 2004).
These increased negative health problems contribute to a greater prevalence of IPV among primary care patients, with current (past year) IPV rates of 15 - 28%, compared to 1.5% to 3% in epidemiologic surveys (Bauer, Rodruguez, Perez-Stable, 2000; Coker, et al., 2000; Collins, et al.,1998; Kramer, Lorenzon, Mueller, 2004; Richardson, et al., 2002; Tjaden & Thoennes, 2000).
In spite of this high prevalence and serious negative health sequelae, a recent review of interventions for IPV concluded that there is a serious lack of evidence-based approaches in the primary care setting.
No studies were identified that examined the effect of physical and mental health symptoms on the ability to access resources or to increase safety promoting behaviors.
This intervention pilot study will speak to this gap in the research.
Utilizing a randomized controlled clinical trial design, we will follow women who screen positive for current (past year) IPV at a primary care clinic in Baltimore, MD.
Women in the control group will receive usual care consisting of a list of community resources for IPV.
Women in the a nurse-managed/community health worker intervention group will receive usual care augmented by an individualized counseling session followed by a series of 6 telephone calls over 10 weeks.
A woman's stage of readiness for change as well as symptoms of pain, fatigue, depression, and PTSD will be evaluated as barriers to resource access and safety behavior initiation.
Study Type
Interventional
Enrollment
40
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
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Maryland
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Baltimore, Maryland, United States, 21215
- The Shepherd's Clinic
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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
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- female
- 18 years of age or older
- speaks English
- reports physical, emotional, and/or sexual abuse by an intimate partner within past 12 months
Exclusion Criteria:
- non-English speaking
- currently pregnant
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Number of safety promotion behaviors at initiation and completion of intervention
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Number of community resources accessed at initiation and completion of intervention
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Secondary Outcome Measures
Outcome Measure |
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Stage of readiness for change at initiaion and completion of intervention
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Severity of pain, fatigue, depressive and PTSD symptoms at initiation and completion of intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne B Woods, PhD, CNM, Johns Hopkins University School of Nursing
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
April 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
April 5, 2007
First Submitted That Met QC Criteria
April 5, 2007
First Posted (Estimate)
April 6, 2007
Study Record Updates
Last Update Posted (Actual)
January 18, 2018
Last Update Submitted That Met QC Criteria
January 16, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NA_00001492
- P30NR008995 (U.S. NIH Grant/Contract)
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.