Skip to content

Addressing the Health Concerns of VA Women With Sexual Trauma

Addressing the Health Concerns of VA Women With Sexual Trauma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02957747
Acronym
SHE
Enrollment
153
Registered
2016-11-08
Start date
2017-06-12
Completion date
2020-05-01
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post-Traumatic, Intimate Partner Violence, Alcohol-Related Disorders

Keywords

Women Veterans, Sexual Trauma

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.

Interventions

BEHAVIORALSHE

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.

Sponsors

Brown University
CollaboratorOTHER
Women and Infants Hospital of Rhode Island
CollaboratorOTHER
VISN 17 Center of Excellence
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Number of Health RisksTwo monthsNumber of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)

Secondary

MeasureTime frameDescription
Adapted Treatment Services Review2 monthSelf-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 Questionnairetime zero (completed immediately after participant receives intervention session)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).

Other

MeasureTime frameDescription
PCL-54 month follow-upSymptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).
Effectiveness in Obtaining Resources Scale2 monthAssesses 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).
Satisfaction With CIAS Software Scaletime zero (completed immediately after participant receives intervention session)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).
30-day Alcohol Timeline Follow Back4 month follow-upCalendar-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).
Alcohol Use Disorder Identification Test (AUDIT)Four-monthsThe 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.
Composite Abuse Scale2 month follow up30 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Safety and Health Experiences Program
Participants in the SHE arm of the study will receive a web-based intervention utilizing motivational interviewing and education. 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.
76
Control
Participants randomized to this arm will receive referrals to VA and community resources
77
Total153

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up105
Overall StudyWithdrawal by Subject03

Baseline characteristics

CharacteristicSafety and Health Experiences ProgramControlTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
76 Participants77 Participants153 Participants
Age, Continuous43.46 years
STANDARD_DEVIATION 9.97
43.63 years
STANDARD_DEVIATION 10.28
43.55 years
STANDARD_DEVIATION 10.1
Ethnicity (NIH/OMB)
Hispanic or Latino
11 Participants12 Participants23 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
65 Participants65 Participants130 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
36 Participants37 Participants73 Participants
Race (NIH/OMB)
More than one race
2 Participants8 Participants10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants5 Participants12 Participants
Race (NIH/OMB)
White
28 Participants26 Participants54 Participants
Region of Enrollment
United States
76 participants77 participants153 participants
Sex: Female, Male
Female
76 Participants77 Participants153 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 760 / 77
other
Total, other adverse events
0 / 761 / 77
serious
Total, serious adverse events
15 / 7612 / 77

Outcome results

Primary

Change in Number of Health Risks

Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)

Time frame: Four months

Population: intent to treat sample

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramChange in Number of Health Risks1.14 number of risksStandard Deviation 0.81
ControlChange in Number of Health Risks1.00 number of risksStandard Deviation 0.81
Primary

Change in Number of Health Risks

Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)

Time frame: Two months

Population: intent to treat sample

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramChange in Number of Health Risks1.38 number of risksStandard Deviation 0.85
ControlChange in Number of Health Risks1.05 number of risksStandard Deviation 0.93
Secondary

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).

Time frame: 2 month

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramAdapted Treatment Services Review7.32 score on a scaleStandard Deviation 10.41
ControlAdapted Treatment Services Review3.89 score on a scaleStandard Deviation 5.56
Secondary

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).

Time frame: 4 month

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramAdapted Treatment Services Review4.59 score on a scaleStandard Deviation 7.34
ControlAdapted Treatment Services Review5.03 score on a scaleStandard Deviation 16.77
Secondary

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 frame: time zero (completed immediately after participant receives intervention session)

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramThe Client Satisfaction Questionnaire26.25 score on a scaleStandard Deviation 4
Other Pre-specified

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).

Time frame: 4 month follow-up

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences Program30-day Alcohol Timeline Follow Back8.5 Drinks per week in the past monthStandard Deviation 11.27
Control30-day Alcohol Timeline Follow Back8.24 Drinks per week in the past monthStandard Deviation 9.03
Other Pre-specified

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).

Time frame: 2 month follow up

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences Program30-day Alcohol Timeline Follow Back10.26 Drinks per week in the past monthStandard Deviation 10.84
Control30-day Alcohol Timeline Follow Back8.26 Drinks per week in the past monthStandard Deviation 9.46
Other Pre-specified

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.

Time frame: Two-months

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramAlcohol Use Disorder Identification Test (AUDIT)4.65 score on a scaleStandard Deviation 5.07
ControlAlcohol Use Disorder Identification Test (AUDIT)5.27 score on a scaleStandard Deviation 5.6
Other Pre-specified

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.

Time frame: Four-months

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramAlcohol Use Disorder Identification Test (AUDIT)4.52 score on a scaleStandard Deviation 5.54
ControlAlcohol Use Disorder Identification Test (AUDIT)4.42 score on a scaleStandard Deviation 5.01
Other Pre-specified

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).

Time frame: 4 month follow-up

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramComposite Abuse Scale7.03 score on a scaleStandard Deviation 11.76
ControlComposite Abuse Scale5.48 score on a scaleStandard Deviation 10.76
Other Pre-specified

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).

Time frame: 2 month follow up

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramComposite Abuse Scale11.25 score on a scaleStandard Deviation 13.87
ControlComposite Abuse Scale6.17 score on a scaleStandard Deviation 9.6
Other Pre-specified

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).

Time frame: 4 month

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramEffectiveness in Obtaining Resources Scale1.48 score on a scaleStandard Deviation 1.67
ControlEffectiveness in Obtaining Resources Scale1.7 score on a scaleStandard Deviation 1.68
Other Pre-specified

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).

Time frame: 2 month

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramEffectiveness in Obtaining Resources Scale1.42 score on a scaleStandard Deviation 1.43
ControlEffectiveness in Obtaining Resources Scale1.88 score on a scaleStandard Deviation 2.17
Other Pre-specified

PCL-5

Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).

Time frame: 2 month follow up

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramPCL-547.16 score on a scaleStandard Deviation 17.54
ControlPCL-542.91 score on a scaleStandard Deviation 19.15
Other Pre-specified

PCL-5

Symptoms of PTSD. Score range 0-80; higher scores indicate more PTSD symptoms (i.e., worse outcome).

Time frame: 4 month follow-up

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramPCL-545.26 score on a scaleStandard Deviation 17.01
ControlPCL-544.81 score on a scaleStandard Deviation 18.29
Other Pre-specified

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 frame: time zero (completed immediately after participant receives intervention session)

ArmMeasureValue (MEAN)Dispersion
Safety and Health Experiences ProgramSatisfaction With CIAS Software Scale30.92 score on a scaleStandard Deviation 0.56

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026