Telephone Intervention to Increase Safety in Abused Women

NCT ID: NCT00457522

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intimate Partner Violence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nurse/community health worker telephone intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anne B Woods, PhD, CNM

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University School of Nursing

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Shepherd's Clinic

Baltimore, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P30NR008995

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00001492

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.