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Completed

NCT Number: NCT00457522

Telephone Intervention to Increase Safety in Abused Women

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Shepherd's Clinic

Baltimore, Maryland, 21215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse/community health worker telephone intervention

Behavioral

Primary outcomes

  1. Number of safety promotion behaviors at initiation and completion of intervention

  2. Number of community resources accessed at initiation and completion of intervention

Secondary outcomes

  1. Stage of readiness for change at initiaion and completion of intervention

  2. Severity of pain, fatigue, depressive and PTSD symptoms at initiation and completion of intervention

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Phone Intervention to Increase Safety in Abused Women: Pilot

Important dates

Study start
2006
Study completion
2006
First posted
Apr 6, 2007
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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