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Telephone Intervention to Increase Safety in Abused Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457522
First Posted: April 6, 2007
Last Update Posted: April 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johns Hopkins University
  Purpose

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.

Condition Intervention
Intimate Partner Violence Behavioral: Nurse/community health worker telephone intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phone Intervention to Increase Safety in Abused Women: Pilot

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Number of safety promotion behaviors at initiation and completion of intervention
  • Number of community resources accessed at initiation and completion of intervention

Secondary Outcome Measures:
  • Stage of readiness for change at initiaion and completion of intervention
  • Severity of pain, fatigue, depressive and PTSD symptoms at initiation and completion of intervention

Estimated Enrollment: 40
Study Start Date: April 2006
Study Completion Date: December 2006
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00457522


Locations
United States, Maryland
The Shepherd's Clinic
Baltimore, Maryland, United States, 21215
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Anne B Woods, PhD, CNM Johns Hopkins University School of Nursing
  More Information

ClinicalTrials.gov Identifier: NCT00457522     History of Changes
Other Study ID Numbers: P30NR008995 ( U.S. NIH Grant/Contract )
First Submitted: April 5, 2007
First Posted: April 6, 2007
Last Update Posted: April 6, 2007
Last Verified: September 2006

Keywords provided by Johns Hopkins University:
intimate partner violence
depression
PTSD
fatigue