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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00457522
Other study ID # NA_00001492
Secondary ID P30NR008995
Status Completed
Phase N/A
First received April 5, 2007
Last updated January 16, 2018
Start date April 2006
Est. completion date December 2006

Study information

Verified date January 2018
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nurse/community health worker telephone intervention


Locations

Country Name City State
United States The Shepherd's Clinic Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of safety promotion behaviors at initiation and completion of intervention
Primary Number of community resources accessed at initiation and completion of intervention
Secondary Stage of readiness for change at initiaion and completion of intervention
Secondary Severity of pain, fatigue, depressive and PTSD symptoms at initiation and completion of intervention
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