Clinical trial NCT02957747: Addressing the Health Concerns of VA Women With Sexual Trauma
Official title: Addressing the Health Concerns of VA Women With Sexual Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Intimate Partner Violence
Alcohol-Related Disorders
Keywords: Women Veterans
Sexual Trauma
Lead sponsor: VISN 17 Center of Excellence
Sponsor class: FED
Collaborators: name: Brown University
name: Women and Infants Hospital of Rhode Island
First posted: 2016-11-08
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

Female Veterans

* Lifetime history of ST with at least one risk factor: heavy drinking within the past 3 months, screen positive for current PTSD or for IPV within last 12 months
* Age 18-65
* Seeking treatment through the Women's Primary Care Clinics at the Central Texas VA Healthcare System.
* Ability to understand study procedures in English
* Not actively in suicidal or homicidal crisis warranting imminent hospitalization

Primary outcomes:
measure: Change in Number of Health Risks
timeFrame: Two months
measure: Change in Number of Health Risks
timeFrame: Four months
Secondary outcomes:
measure: Adapted Treatment Services Review
timeFrame: 2 month
measure: Adapted Treatment Services Review
timeFrame: 4 month
measure: The Client Satisfaction Questionnaire
timeFrame: time zero (completed immediately after participant receives intervention session)
Other outcomes:
measure: Effectiveness in Obtaining Resources Scale
timeFrame: 2 month
measure: Effectiveness in Obtaining Resources Scale
timeFrame: 4 month
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Four-months
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Two-months
measure: Composite Abuse Scale
timeFrame: 2 month follow up
measure: PCL-5
timeFrame: 4 month follow-up
measure: Composite Abuse Scale
timeFrame: 4 month follow-up
measure: PCL-5
timeFrame: 2 month follow up
measure: 30-day Alcohol Timeline Follow Back
timeFrame: 4 month follow-up
measure: 30-day Alcohol Timeline Follow Back
timeFrame: 2 month follow up
measure: Satisfaction With CIAS Software Scale
timeFrame: time zero (completed immediately after participant receives intervention session)
Locations:
city: Temple
country: United States
facility: Central Texas Veterans Healthcare System
state: Texas
city: Waco
country: United States
facility: Central Texas Veterans Healthcare System
state: Texas
Study officials:
affiliation: Brown University
name: Caron Zlotnick, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VHA VISN 17 COE
name: Suzannah Creech, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Creech SK, Pulverman CS, Kahler CW, Orchowski LM, Shea MT, Wernette GT, Zlotnick C. Computerized Intervention in Primary Care for Women Veterans with Sexual Assault Histories and Psychosocial Health Risks: a Randomized Clinical Trial. J Gen Intern Med. 2022 Apr;37(5):1097-1107. doi: 10.1007/s11606-021-06851-0. Epub 2021 May 19.