Addressing the Health Concerns of VA Women With Sexual Trauma (SHE)
Primary Purpose
Stress Disorders, Post-Traumatic, Intimate Partner Violence, Alcohol-Related Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHE
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Women Veterans, Sexual Trauma
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
Sites / Locations
- Central Texas Veterans Healthcare System
- Central Texas Veterans Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Safety and Health Experiences Program
Control
Arm Description
Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education.
Participants randomized to this arm will receive referrals to VA and community resources
Outcomes
Primary Outcome Measures
Change in Number of Health Risks
Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)
Change in Number of Health Risks
Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)
Secondary Outcome Measures
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).
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).
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).
Full Information
NCT ID
NCT02957747
First Posted
September 21, 2016
Last Updated
December 7, 2020
Sponsor
VISN 17 Center of Excellence
Collaborators
Brown University, Women and Infants Hospital of Rhode Island
1. Study Identification
Unique Protocol Identification Number
NCT02957747
Brief Title
Addressing the Health Concerns of VA Women With Sexual Trauma
Acronym
SHE
Official Title
Addressing the Health Concerns of VA Women With Sexual Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VISN 17 Center of Excellence
Collaborators
Brown University, Women and Infants Hospital of Rhode Island
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
Develop the preliminary computer-based intervention, incorporating information gained in informant interviews.
Perform a small open trial (n = 20) of SHE to assess feasibility of recruitment of target population and acceptability of intervention and study procedures.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic, Intimate Partner Violence, Alcohol-Related Disorders
Keywords
Women Veterans, Sexual Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Safety and Health Experiences Program
Arm Type
Experimental
Arm Description
Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants randomized to this arm will receive referrals to VA and community resources
Intervention Type
Behavioral
Intervention Name(s)
SHE
Other Intervention Name(s)
Safety and Health Experiences program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Number of Health Risks
Description
Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)
Time Frame
Two months
Title
Change in Number of Health Risks
Description
Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)
Time Frame
Four months
Secondary Outcome Measure Information:
Title
Adapted Treatment Services Review
Description
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).
Time Frame
2 month
Title
Adapted Treatment Services Review
Description
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).
Time Frame
4 month
Title
The Client Satisfaction Questionnaire
Description
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 Frame
time zero (completed immediately after participant receives intervention session)
Other Pre-specified Outcome Measures:
Title
Effectiveness in Obtaining Resources Scale
Description
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).
Time Frame
2 month
Title
Effectiveness in Obtaining Resources Scale
Description
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).
Time Frame
4 month
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
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.
Time Frame
Four-months
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
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.
Time Frame
Two-months
Title
Composite Abuse Scale
Description
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).
Time Frame
2 month follow up
Title
PCL-5
Description
Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).
Time Frame
4 month follow-up
Title
Composite Abuse Scale
Description
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).
Time Frame
4 month follow-up
Title
PCL-5
Description
Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).
Time Frame
2 month follow up
Title
30-day Alcohol Timeline Follow Back
Description
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).
Time Frame
4 month follow-up
Title
30-day Alcohol Timeline Follow Back
Description
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).
Time Frame
2 month follow up
Title
Satisfaction With CIAS Software Scale
Description
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 Frame
time zero (completed immediately after participant receives intervention session)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caron Zlotnick, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suzannah Creech, PhD
Organizational Affiliation
VHA VISN 17 COE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Texas Veterans Healthcare System
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States
Facility Name
Central Texas Veterans Healthcare System
City
Waco
State/Province
Texas
ZIP/Postal Code
76711
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No IPD will be made available for sharing
Citations:
PubMed Identifier
34013470
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.
Results Reference
derived
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Addressing the Health Concerns of VA Women With Sexual Trauma
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