Addressing the Health Concerns of VA Women With Sexual Trauma (SHE)

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.

Study Overview

• Status: Completed
• Conditions: Alcohol-Related Disorders; Stress Disorders, Post-Traumatic; Intimate Partner Violence
• Intervention / Treatment: Behavioral: SHE

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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Temple, Texas, United States, 76504
      • Central Texas Veterans Healthcare System
    • Waco, Texas, United States, 76711
      • Central Texas Veterans Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety and Health Experiences Program; Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education.	Behavioral: SHE; 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 Names: Safety and Health Experiences program
No Intervention: Control; Participants randomized to this arm will receive referrals to VA and community resources

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of Health Risks	Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)	Two months
Change in Number of Health Risks	Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)	Four months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adapted Treatment Services Review	Self-report and chart review of utilization of mental health and substance abuse treatment. Range is open, as measure assesses women's self-report of treatment appointments. Higher scores indicate a greater number of treatment appointments and thus greater use of treatment (i.e., better outcome).	2 month
Adapted Treatment Services Review	Self-report and chart review of utilization of mental health and substance abuse treatment. Range is open, as measure assesses women's self-report of treatment appointments. Higher scores indicate a greater number of treatment appointments and thus greater use of treatment (i.e., better outcome).	4 month
The Client Satisfaction Questionnaire	8-item questionnaire which assesses the participant's satisfaction with the intervention. Score range 4-32; higher scores indicate higher satisfaction with the intervention (i.e., better outcome).	time zero (completed immediately after participant receives intervention session)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness in Obtaining Resources Scale	Assesses women's effectiveness in obtaining resources from 11 different types of community resources including church or clergy, health care, legal services, police, or social services. Reporting the subscale for "Things I have been successful at." Score range 0-13; higher scores indicate obtaining more resources (i.e., better outcome).	2 month
Effectiveness in Obtaining Resources Scale	Assesses women's effectiveness in obtaining resources from 11 different types of community resources including church or clergy, health care, legal services, police, or social services. Reporting the subscale for "Things I have been successful at." Score range 0-13; higher scores indicate obtaining more resources (i.e., better outcome).	4 month
Alcohol Use Disorder Identification Test (AUDIT)	The AUDIT is a 10-item assessment for alcohol use problems, alcohol dependence and problem drinking. Participants respond to each item along 5-point scale ranging from 0 to 4, whereby higher scores reflect more severe alcohol use patterns. Responses are summed to reflect a total score ranging from 0 to 40, with higher scores reflecting higher severity of an individual's use of alcohol.	Four-months
Alcohol Use Disorder Identification Test (AUDIT)	The AUDIT is a 10-item assessment for alcohol use problems, alcohol dependence and problem drinking. Participants respond to each item along 5-point scale ranging from 0 to 4, whereby higher scores reflect more severe alcohol use patterns. Responses are summed to reflect a total score ranging from 0 to 40, with higher scores reflecting higher severity of an individual's use of alcohol.	Two-months
Composite Abuse Scale	30 item measure of chronicity and occurrence of intimate partner violence with current partner in past 12 months. Score range from 0-150; higher scores indicate more intimate partner violence (i.e., worse outcome).	2 month follow up
PCL-5	Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).	4 month follow-up
Composite Abuse Scale	30 item measure of chronicity and occurrence of intimate partner violence with current partner in past 12 months. Score range from 0-150; higher scores indicate more intimate partner violence (i.e., worse outcome).	4 month follow-up
PCL-5	Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).	2 month follow up
30-day Alcohol Timeline Follow Back	Calendar-assisted measure used to garner a retrospective account of drinking behavior. Scale is in standard alcoholic drinks in an average week in the past month. Higher numbers indicate more drinks per week (i.e., worse outcome).	4 month follow-up
30-day Alcohol Timeline Follow Back	Calendar-assisted measure used to garner a retrospective account of drinking behavior. Scale is in standard alcoholic drinks in an average week in the past month. Higher numbers indicate more drinks per week (i.e., worse outcome).	2 month follow up
Satisfaction With CIAS Software Scale	Assesses participant satisfaction with the computerized software with items on likeability, ease of use, level of interest, and respectfulness. Score range is 7-35; higher numbers indicate higher satisfaction with the software (i.e., better outcome).	time zero (completed immediately after participant receives intervention session)

Collaborators and Investigators

• Sponsor: VISN 17 Center of Excellence
• Collaborators: Brown University; Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Caron Zlotnick, PhD, Brown University; Principal Investigator: Suzannah Creech, PhD, VHA VISN 17 COE

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Women Veterans; Sexual Trauma
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Disease; Stress Disorders, Post-Traumatic; Alcohol-Related Disorders; Sexual Trauma
• Other Study ID Numbers: 00614

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be made available for sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No