Addressing the Health Concerns of VA Women With Sexual Trauma
Condition: Stress Disorders, Post-Traumatic; Intimate Partner Violence; Alcohol-Related Disorders
MeSH terms: Alcohol-Related Disorders; Stress Disorders, Post-Traumatic; Sexual Trauma
Study type: Interventional

Summary: 
      Lifetime sexual trauma (ST) (i.e., behaviors that range from unwanted sexual touching to
      attempted or completed rape) is a significant social and public health problem among women
      Veterans. For women Veterans, lifetime ST can occur prior to, during or after military
      service. ST is associated with multiple difficulties and risks, including posttraumatic
      stress disorder (PTSD), intimate partner violence (IPV), and alcohol misuse. Providing an
      effective, integrated, and low-cost intervention that targets ST-related risks for women
      Veterans with lifetime ST would advance clinical care for these vulnerable women.

      This research will develop and assess a computer-delivered intervention (Safety and Health
      Experiences Program; SHE) that will provide a screening and brief behavior intervention for
      women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address
      interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD).
      SHE will be designed to provide individualized assessment, feedback, and referrals for women
      Veterans with any lifetime ST. SHE will take place within a primary care setting. Primary
      care visits are frequent points of health care contact for women Veterans making the visit
      itself the ideal, and possibly only, opportunity to provide behavioral interventions.

      This study will lay the groundwork for a larger clinical trial of the SHE program in multiple
      VA primary care settings. If effective, the intervention, SHE, represents an innovative and
      low cost service for early identification and intervention that could be implemented
      nationwide with ease and speed to address the needs of women Veterans with lifetime ST. The
      long-term goal of the project is to make a significant impact on advancing health services
      research by introducing and testing a novel and potentially powerful service tool that may
      improve service delivery to address the co-occurring health concerns for women Veterans with
      any lifetime ST.
    

Detailed description: 
      The VA Women's Health Research Agenda underscores the importance of improving the safety and
      health outcomes of returning Veteran women. With greater numbers of women joining the
      military, the need for gender-specific VA-based interventions is increasingly important.
      Posttraumatic stress disorder (PTSD), intimate partner violence (IPV), and alcohol use are
      closely interrelated and significant concerns for women Veterans with a history of sexual
      trauma (ST). Given that screening for military sexual trauma (MST) is mandated within VAs, a
      computer delivered intervention has the potential to be easily integrated into the standard
      of care for women who screen positive for MST and/or other lifetime STs, increasing the
      identification of high-risk women Veterans. This intervention will provide a computer-based
      intervention on a VA issued laptop that could improve delivery service and fill a healthcare
      gap for a vulnerable Veteran population.

      The long-term goal of the project is to make a significant impact on advancing health
      services research by introducing and testing a novel and potentially powerful service tool
      that may improve service delivery to address the co-occurring health concerns for VA women
      with lifetime ST. The intervention, Safe and Healthy Experiences (SHE), a brief modular,
      computer-based intervention, will target interrelated health risks for women Veterans with
      lifetime ST (i.e. alcohol misuse, IPV, and PTSD). SHE will provide individualized assessment,
      feedback, and referrals for women Veterans with lifetime ST. The intervention is based on
      motivational interviewing (MI), a well-defined intervention strategy that has yielded
      particularly promising results in a range of clinical issues, including interpersonal
      violence, and a range of patient populations, including male and female Veterans. MI is a
      collaborative and non-confrontational approach that emphasizes increasing a participant's
      awareness of successful steps towards well-being. MI is consistent with an empowerment model,
      which is a highly recommended intervention model for victimized women and both MI and an
      empowerment model converge on important principles for intervening with victimized women.

      Findings from the study will provide the necessary groundwork to examine the efficacy of SHE
      in a future, large clinical trial. If the SHE intervention is found to be feasible,
      acceptable and efficacious in improving outcomes for women Veterans with lifetime ST, the
      ultimate goal would be for the program to be integrated into clinical care and widely
      disseminated. There are two phases of research directed toward these aims: 1) develop and
      refine an integrated screening and behavior intervention for VA women with lifetime ST in a
      brief modular computer-based format that can be administered in a VA primary care setting,
      and 2) collect data on the feasibility, acceptability, and initial efficacy of the
      intervention in improving the health of VA women, and increasing utilization of treatment and
      resources.

      The study aims are to:

        1. Develop the preliminary computer-based intervention, incorporating information gained in
           informant interviews.

        2. Perform a small open trial (n = 20) of SHE to assess feasibility of recruitment of
           target population and acceptability of intervention and study procedures.

        3. Conduct an initial randomized control trial in a sample of 150 women Veterans who screen
           positive for lifetime sexual trauma (ST) and have at least one risk factor (i.e., screen
           positive for intimate partner violence (IPV), posttraumatic stress disorder (PTSD),
           and/or heavy drinking) to demonstrate the feasibility of SHE and the acceptability of
           SHE via participant report of ease of use, helpfulness, and overall satisfaction.

        4. Examine preliminary evidence for the hypotheses that, relative to the control condition,
           screening and referral only (SR), SHE will result in:

             -  Decreases in the number of risks (i.e., heavy drinking (4+ drinks on one occasion),
                screen positive for PTSD, screen positive for IPV) at the 2- and 4-month follow-up
                (primary).

             -  Increases in resource and treatment utilization over the 2- and 4-month follow-up
                period (secondary).

      The data will be used to demonstrate whether the effects of the intervention look promising
      to support a future large-scale randomized control trial and to suggest, in concert with
      results from clinical trials in related fields, the range of effect sizes that would be
      reasonable to expect in a future trial.

      This is a multi-site study. At the Providence, RI based site (Women and Infants Hospital and
      Brown University), the specialized computer-based assessment and interactive intervention
      sessions will be developed and designed and staff members will also assist with data
      management. The Central Texas VA Healthcare System site will be the data collection site and
      the main site for participant recruiting, consenting, enrollment, intervention and follow-up.
      Staff at the two sites will work collaboratively throughout the project to supervise study
      staff, for reporting to the DOD and IRB's and in designing the assessment and intervention
      sessions, however, only the study staff at the Central Texas site will have access to
      participant PHI.
    

Intervention name(s): SHE
Intervention type(s): Behavioral
Intervention description(s): SHE is a computer-delivered intervention (Safety and Health Experiences Program; SHE) that will provide a screening and brief behavior intervention for women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD). SHE will provide individualized assessment, feedback, and referrals for women Veterans with any lifetime ST. SHE will take place within a primary care setting.
Other intervention name(s): Safety and Health Experiences program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Women Veterans; Sexual Trauma