Addressing the Health Concerns of VA Women With Sexual Trauma
Phase: NA
Conditions: Stress Disorders, Post-Traumatic, Intimate Partner Violence, Alcohol-Related Disorders
Sponsor: VISN 17 Center of Excellence

1 
 
Central Texas VA Healthcare System research protocol. 
Title: Addressing the Health Concerns of VA Women with Sexual Trauma 
Sponsor: Department of Defense 
Principal Investigator: Suzannah Creech 
Version date:  10.26.2018 
 
Key Personnel: Central Texas VA Healthcare System, Temple, TX and the VHA VISN 17 
Center of Excellence for Research on Returning War Veterans, Waco, TX site 
Suzannah Creech, Ph.D. 
  
Psychologist, Treatment Core 
 
VHA VISN 17 COE 
 
Assistant Professor (Research) 
  
Dept. of Psychiatry and Human Behavior,  
Brown University 
 
Joseph Mignogna, Ph.D. (Co-PI) 
Psychologist, Behavioral Sciences Core 
VHA VISN 17 COE 
Associate Professor 
Department of Psychiatry and Behavioral Sciences 
Texas A&M University Health Science Center 
 
 
Key Personnel: Women and Infants Hospital and Brown University, Providence, RI study 
site: 
Caron Zlotnick, Ph.D.  
 
Director of Behavioral Medicine Research 
 
Women and Infants Hospital 
 
Professor (Research) 
  
Dept. of Psychiatry and Human Behavior, Medicine, Ob/Gyn 
 
Brown University 
  
 
 
M. Tracie Shea, Ph.D. 
Staff Psychologist 
Veterans Affairs Medical Center 
Dept. of Psychiatry and Human Behavior 
Brown University 
 
Christopher Kahler, Ph.D. 
Director of Biostatistics at the Center for Alcohol and  
Addiction Studies 
Professor of Behavioral and Social Sciences  
Scientific Director of the Alcohol Research Center on HIV 
Brown University 
 
Golfo Tzilos, Ph.D. 
Research Psychologist 

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Butler Hospital 
Brown University Alpert Medical School 
 
Lindsay Orchowski, Ph.D. 
Staff Psychologist 
RI Hospital 
Assistant Professor (Research) 
Dept. of Psychiatry and Human Behavior 
Brown University Alpert Medical School 
 
Appendices: 
1. Study Measures 
2. Interview questions (informant, exit) 
3. Recruitment Flyer 
4. Recruitment letter 
5. Phone script 

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Addressing the Health Concerns of VA Women with Sexual Trauma 
 
Section 1. Overview of the study and procedures 
 
The VA Women’s Health Research Agenda[1] 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 [2,3]. 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. Our proposal would provide a computer-based intervention on a 
VA computer issued laptop that could improve delivery service and fill a healthcare gap for a 
vulnerable Veteran population. 
The long-term goal of the proposed work 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 be designed to provide 
individualized assessment, feedback, and referrals for women Veterans with lifetime ST.  The 
intervention we propose will be 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[4], and a range of patient populations, including male and female 
Veterans[5].  MI is a collaborative and non-confrontational approach that emphasizes increasing a 
participant’s awareness of successful steps towards her own well-being.  MI is consistent with an 
empowerment model, which is a highly recommended intervention model for victimized 
women[6] and both MI and an empowerment model converge on important principles for 
intervening with victimized women[7]. 
We anticipate that findings from the proposed 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 our program to be integrated 
into clinical care and widely disseminated.  We have proposed 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 our proposed 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 no more than 155 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 

4 
 
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. 
 
 
Section 2. Study Background 
 
Sexual trauma is a wide spread and significant public health concern among women 
Veterans[8-10]:  Lifetime Sexual Trauma (ST) (i.e., behaviors that range from unwanted sexual 
touching to attempted or completed rape) disproportionately affects women and can threaten the 
health and well-being of women[8-10].  Women Veterans have increased rates of ST compared to 
civilian women[11,12].  For women Veterans, lifetime ST can occur prior to, during or after 
military service[13].  A recent study of women Veterans (N=1004) reported that two thirds (62%) 
of participants reported lifetime sexual assault, including 11% reporting attempted rape and 51% 
reporting at least one completed rape, and the highest rates of rape occurred during childhood 
and the military service[13]. Women Veterans report substantially higher rates of MST than male 
Veterans[14-16].  For women, prevalence rates of MST range from 22% to 45%.[17-23]  MST is 
associated with a range of consequences, including PTSD, depression, health complaints, and 
complications in sexual functioning[18-21,24].  Research has found that among women Veterans, 
lifetime ST victims report a more extensive trauma history and demonstrate greater 
psychological impairment compared to those reporting other types of trauma[19].  Lifetime ST is 
associated with multiple health problems and risks[25-29], increased health care utilization[30], 
decreased work capacity[31], and a range of mental health consequences[10,32,33], that include 
PTSD, problem drinking and IPV.   
  
PTSD is more prevalent among women Veterans than women in the community: 
PTSD is especially prevalent in women: 3.6% of men vs. 9.7% of women have lifetime 
PTSD[34,35].  Additionally, epidemiological studies have found ST is associated with the highest 
likelihood of PTSD[36,37].  Given this, and the fact that women Veterans have higher rates of ST 
compared to civilian women[11,12], it is not surprising that female Veterans’ rates of lifetime 
PTSD (22%) are more than double the rate of women in the general community.[38,39]  PTSD 
among women Veterans has been associated with poor psychiatric and physical functioning[20]. 
Compared to male Veterans, women Veterans with PTSD were more likely to have higher 

5 
 
mental health, primary care, and emergency care use[40].  PTSD is a disorder of great morbidity.  
Even subthreshold PTSD is associated with significant psychosocial impairment, comorbidity, 
suicidality, and subjective distress [41-44].     
Problematic alcohol use is prevalent among women Veterans:  Rates of problematic 
alcohol use among female Veterans are estimated at 31%[13,45,46].  A large study of women 
Veterans who had some contact with the VA health care system reported that these women 
Veterans were at high risk for the negative consequences of alcohol and drug use, in rates that 
are greater than in the general population[13].  The individual and community consequences of 
alcohol misuse are estimated at over $184.6 billion[47], and include motor vehicle accidents[48], 
violent crime victimization and perpetration[49], mental health problems[50,51] and a range of 
medical consequences[52].  Despite these alcohol-related consequences, women Veterans report 
low utilization of substance use treatment services[53]. 
IPV is more prevalent among women Veterans than women in the community:  
Veteran women are more likely than non-Veteran women to report lifetime IPV victimization 
(33.0% vs. 23.8%)[54].  Consistent with the larger literature, IPV among women Veterans is 
associated with increased health risks, including increased heart health risk factors, smoking, and 
heavy drinking[54].  IPV has wide-ranging and profound effects on health, adversely affecting 
eight of ten of the leading health indicators identified by the Department of Health & Human 
Services (DHHS) [55-57] and leading to an estimated medical cost burden up to USD 7.0 billion 
annually[10,58]. Fatalities from IPV account for 30-50% of all female homicides in the U.S. each 
year[56,57]. 
The need to screen and intervene for PTSD, IPV, and alcohol misuse among women 
Veterans with lifetime ST:  ST is strongly associated with PTSD, IPV, and alcohol misuse. 
Community based studies have found that ST is associated with the highest likelihood of 
PTSD[36,37].  Women with ST are also likely to be victims of IPV[59]. In addition, alcohol use 
often increases following experiences of ST [60-65].  Alcohol, PTSD, and IPV, are also interrelated 
risks for women. For instance, IPV exposure is associated with heavy drinking among women 
Veterans[54] and alcohol misuse problems are more prevalent among women Veterans diagnosed 
with PTSD[46] as well as women Veterans with higher levels of PTSD[66,67]. Despite the high-risk 
profile of women Veterans with lifetime ST, only 38% of ST survivors seen within a VA 
primary care setting used mental health services in the past year[19].  Although there is a current 
mandate of screening for MST, researchers have recommended that this screening include pre- 
and postmilitary sexual assault history because of the high rates of lifetime ST,  the range of ST-
related morbidities, as well as the importance of connecting more Veterans to much needed 
services[19].  Furthermore, the Veterans Health Administration (VHA) has no systematic screen 
and intervention for other ST-related traumas (e.g., IPV[68], childhood STs, or STs after military 
service) in place, nor does the VHA screen and address the serious health risks associated with 
lifetime ST within a comprehensive program.   
Primary care clinics are ideal settings to reach our target population:  Primary care 
settings are frequent points of health care contact for VA women[19], making the visit itself the 
ideal, and possibly only, opportunity to provide behavioral interventions.  Research has 
identified numerous health care providers’ barriers to screening and intervention for lifetime ST, 
IPV, PTSD, and alcohol that include lack of time and support resources, low level of confidence 
in screening and intervening, lack of education and training, and fear of offending the patient[69-
72].  Despite the high prevalence of alcohol use, IPV, and PTSD among VA women with lifetime 
ST and the significant morbidity associated with having coexisting problems (see Section A1 for 
details), current systems are not in place to adequately evaluate and intervene with these co-
occurring problems.   
Use of a computer-based format will optimize the consistency, feasibility, and 
uptake of an intervention for women Veterans with ST:  Computer-delivered interventions 
for women Veterans with lifetime ST is a novel approach and can overcome existing obstacles 
by providing brief interventions, at a low cost, without requiring substantial investments of time 
or energy from health care providers. Other advantages include: First, as technology-based 
screening becomes a routine part of health care, the proportion of women Veterans with any ST 

6 
 
history who are screened would increase dramatically. Second, because women may disclose 
stigmatized behaviors more readily in computer-based interviewing, a higher proportion of 
women would be identified.  Research has found that audio computer-assisted self-interview 
(ACASI) screening consistently identifies a higher prevalence of interpersonal trauma among 
women (when compared to written or interview format) and was the most preferred approach by 
women participants[73]. Third, computer-delivered brief interventions can take place in waiting 
or examination rooms without limitation of provider time, willingness, or ability. Further, touch 
screen technology makes interacting with the computer easy and intuitive for anyone. Simple 
headphones and spoken text allow the computer to be accessible to those at any literacy level, 
and confidential in even the most public of settings. Computer-delivered brief interventions 
require little direct clinician involvement.  They can be adapted to be culturally and linguistically 
specific, and can provide individualized feedback to participants immediately and in an engaging 
manner.  They can deliver assessments and, based on the results, provide individualized 
recommendations for change. They are able to store information so that progress over time can 
be accurately monitored and reviewed with the participant. They minimize the bias that can arise 
in clinical relationships. An intervention, if proven effective, can also be widely disseminated 
while maintaining treatment fidelity among clinical sites. Adult women have reported increasing 
comfort with the use of technology, including the Internet and email, for obtaining health 
information[74].   
 
Summary: The proposed project will develop and assess an innovative, high-reach, easily 
implementable, low-cost computer-delivered intervention (Safe and Healthy Experiences; 
SHE) for women Veterans with any lifetime ST that will address known barriers in early 
identification and intervention of ST-related risks within a primary care setting.  Since 
screening for MST is mandated within the VA, the SHE intervention also closes the gap between 
efforts to identify ST and then link Veterans to effective care.  If the proposed project is found to 
be feasible and effective, it represents a cost-effective service that may be scaled up nationwide 
with ease, fidelity, and speed to address the health needs of VA women with lifetime ST.   
 
 
Section 3. Study Methods 
Overview 
All study assessments and intervention sessions will be delivered on a laptop/tablet device using 
audio computer-assisted self-interview software. Veterans will input responses to assessment 
measures directly.  
 
The specific aims of this research proposal are as follows:  
1.  Development Aims: Stage 1A aims to adapt the structure, and content of our existing 
interventions to develop a computer-based screening and brief health intervention program that 
includes modules on: 1) alcohol use; 2) PTSD, and 3) IPV and tailor the modules to women 
Veterans with lifetime ST using information gathered from informant interviews with 34 women 
Veterans with lifetime ST. The resulting computer-based intervention will be refined through an 
open pilot trial in a sample of 20 women with lifetime ST seeking VA primary care and with at 
least one ST-related risk. 
 
2.  Trial Aims: Stage 1B aims to conduct an initial randomized controlled trial in a 
sample of no more than 155 women with lifetime ST who screen positive for at least one of the 
risk factors (heavy drinking, PTSD or IPV) to demonstrate the feasibility of the proposed 
recruitment methods, design, and delivery of the intervention. We will examine evidence for the 
hypotheses that the intervention, relative to the control group, at the 2- and 4-month follow-up 
period from baseline, will reduce the number of risks (i.e., heavy drinking (4+ drinks), a positive 
screen for PTSD, a positive screen for IPV). As a secondary outcome, we will also examine 
whether the intervention, relative to the control group, increases resource and treatment 
utilization over the 2- and 4-month follow-up from baseline.  The team will review experiences 

7 
 
and outcomes for both the open trial and the initial randomized control study. Results from this 
proposal will be used as data for a future large-scale randomized control trial.  The team of 
investigators brings a wealth of complementary experience and is extremely well-suited to carry 
out the proposed research. 
 
 
 
Intervention Development  
At the site in Providence, RI, the team of investigators will design a preliminary outline 
of each of the modules for the computer-based intervention.  The new intervention will be 
theory-driven, consistent with the MI model of behavior, and informed by our existing 
empirically-based programs that address alcohol use[75], IPV[76], and PTSD[77].  Each module will 
Informant Interview 
N = 34

8 
 
be carefully designed to attend to the unique cultural background and experiences of women who 
have served in the military. Dr. Zlotnick (PI) has had extensive experience in developing 
interventions for high risk women[78,79], women with interpersonal violence[76,77] and women with 
PTSD[77,80-82].  Dr. Shea (Co-I) has research and clinical expertise in the area of PTSD in Veteran 
populations. Dr. Creech (Co-I; CTVHCS site PI) has extensive research and clinical expertise in 
Women Veterans mental health, military sexual trauma, and intimate partner violence 
interventions for Veterans. Dr. Kahler (Co-I) is highly experienced in developing motivational 
interventions to address alcohol use, including protocols that include personalized feedback 
reports, and serves as the Director of Biostatistics for the Center for Alcohol and Addiction 
Studies.  Dr. Tzilos (Co-I) has specific expertise in the development of computer-based MI 
protocols for problem drinking with women, including the use of CIAS software. Finally, Dr. 
Orchowski (Co-I) has expertise in the development of scripts and videos for use in risk reduction 
programs for women with ST.   
 
Subjects 
We will sample consecutive eligible patients from Women’s Primary Care at the Waco 
and Temple VA medical centers.  Participants will be women Veterans seeking treatment in 
women’s primary care..  Participants must report a history of lifetime ST and have at least one of 
the following risks: 1) Alcohol (i.e., report exceeding the national recommended limits for daily 
drinking (4 or more for women) on at least one occasion in the past month); 2) PTSD (i.e., screen 
positive for current PTSD) and screen positive for IPV within the last 12 months. Participants 
who indicate one or more of these risk factors will be included in the study.  Other inclusion 
criteria will be ability to understand study procedures in English, be between the ages of 18 and 
65, and willingness to complete follow-up session. In future studies, the computer software can 
be modified to present information in Spanish for the Latina population. 
 
Inclusion/ Exclusion Criteria 
Inclusion Criteria 
-Female Veterans  
 
-Lifetime history of ST with at least one risk factor:  heavy drinking, 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 
 
For this study, we will test the proposed intervention for English-speaking women Veterans only, 
because translation of the intervention and related assessments could not take place within the 
time constraints/demands of the current study.  In future studies, the computer software can be 
modified to present information in Spanish for the Latina population.  We specified the upper 
age limit because it reduces the likelihood of including women Veterans who have age-related 
brain diseases, which might confound our findings. 
 
Inclusion of Women  This proposal is primarily designed to investigate the efficacy of an 
intervention for women Veterans with ST.  By definition, no adult men will participate in this 
study and adult women will be adequately represented. We will enroll women Veterans meeting 
inclusion criteria.  Males will be excluded from participation because research has indicated a 
high prevalence of lifetime ST against women Veterans.   

9 
 
 
Inclusion of Minorities  We expect that the representation of minorities in our sample 
will closely align to the demographics profile of women Veterans receiving care at CTVHCS. 
Specifically, American Indian/Alaska Native (.9%); Asian (1.4%); Black/African American 
(35.3%); Hispanic (9.4%); Native American/Other Pacific Islander (1.5%); White (45%).  
 
Inclusion of Children:  Children under the age of 18 will not be included. The target 
population is women Veterans, and the minimum age to serve in the military is 18. 
 
Recruitment Procedures 
The primary recruitment sites will be the women’s primary care clinics at CTVHCS. 
Specifically, we plan to recruit from the clinics in Waco and Temple.  
 
Screening and Informed Consent Procedures 
Screening:  Two recruitment strategies will be utilized: 
1. Potential participants who are at the clinic for a medical visit will be approached while in 
the waiting room. Participants will be given the study flyer and asked if they would be interested 
in participating in a study on women veterans’ health that will take about 45 minutes that day. 
Depending on the time of her appointment, she may be screened either before or after. If the 
participant is unable to be screened that day, she will be invited to come back at another time for 
screening or to be screened at her next appointment. We have obtained approval for waiver of 
HIPAA authorization for the purposes of recruitment in order to track future appointments for 
women who are interested in being screened at a later date, to predict clinic flow, and to identify 
potential participants. As determined by patient flow at the clinics, it is anticipated that the 
research assistant for the study will split her time between the women’s clinic in Temple (2-3) 
days a week and the women’s clinic in Waco (2 days a week).  
2. The study analyst will utilize VA administrative databases to request a list of all female 
Veterans that have had an appointment at the Temple VA Women’s clinic and Waco VA 
Women’s clinic within the past month, and any upcoming appointments in the current and 
upcoming month. At the Temple clinic, data will be pulled only from the days that recruitment 
did not take place.  Following standard VA procedures and data pull approval processes, once 
every month during the recruitment period the study analyst will pull the contact information 
(addresses and phone numbers) of female Veterans with appointments 30 days prior to the data 
pulling date and 30 days following that date. These women will be sent a letter informing them 
of the study and the follow up phone call they will receive from a research assistant inquiring 
about their interest in taking the screener. If a Veteran indicates that she is not interested at any 
point in this process (e.g., after the first letter, or during the follow-up call), their name will be 
marked off the list and they will not be contacted again. 
 
3. Potential participants will also be recruited through advertisement at enrollment sites  
(e.g., blood lab; see attached flyer) and additionally at the Mental Health and Substance Abuse 
clinics located at the Waco and Temple VA campuses. The women’s clinic in Temple has a 
dedicated research office that is connected to the waiting room and the study team has access to 
another research office in building 205 for appointments as well. The Waco women’s clinic is 
adjacent to the COE building which has private rooms dedicated to research. 
For women who are interested, the research assistant (RA) will escort them to a private 
office or other private space where the RA will introduce the computer screener for the study, 
which will be described as a survey to help women Veterans be healthy. Women’s clinic staff 
will be informed that the veteran is being screened for the study and of her whereabouts as clinic 
operations will always take priority. In a private setting, potential participants will be told that 
the purpose of screening is to find women who may be eligible for a study on risk factors among 
women Veterans and what is involved with participating in the study.  Potential participants will 
be asked to provide signed informed consent and HIPAA authorization.  Following consent, 
participants will be asked if they had anything alcoholic to drink on the same day of their 

10 
 
appointment at the women’s clinic.  If so, the participant will be provided with referrals, and 
screening will be postponed until their period of intoxication is over on the same day or 
rescheduled for a later date.  To guarantee that the participant is not intoxicated prior at the time 
of screening, any participant who had either initially endorsed drinking alcohol prior to their 
rescheduled appointment and who did not endorse drinking alcohol on the day of their 
rescheduled appointment or participants who do not endorse drinking alcohol but exhibit 
behaviors consistent with intoxication (e.g., slurred speech, belligerence, etc…) will be 
administered a breath alcohol test, and must register <.02 breath alcohol content.  Once it is 
determined that the participant is not intoxicated, she will complete the 30-minute screener using 
the CIAS software delivered on a VA issued/ approved laptop computer or desktop computer to 
determine study eligibility. Participants will wear headphones to hear the audio for the 
computerized screening and a screen protector will be on the computer so no one could 
inadvertently observe the screen. The use of audio computer-assisted self-interview software to 
conduct screening will maximize identification rates of women Veterans with ST, IPV, alcohol 
misuse, and PTSD.  The screener will include a brief series of questions about general health, 
exercise, diet, smoking, and sunscreen. The screener will also include the following well-
validated, reliable and recommended measures:  Participants must report a history of lifetime ST 
(as identified by the Sexual Experiences Survey—Short Form Victimization (SES-SFV)[83], 
items from the VA MST screener[84-86], and the Childhood Sexual Victimization Questionnaire 
(CSVQ)[87,88]) and have at least one of the following risks: 1) Alcohol (i.e., report exceeding the 
national recommended limits[89,90] for daily drinking (4 or more for women) on at least one 
occasion in the past three months as indicated on the Graduated Frequency Measure (GFM)[91].); 
2) PTSD (i.e., screen positive for current PTSD with a cut point of  ≥36[92] on the PTSD 
Checklist  for DSM-V [93]; and IPV within the last 12 months (i.e., score 4 or more on the 
Woman Abuse Screening Tool (WAST)[99]).   
All patients screened will receive a standard health information brochure with further 
information and resources on the health topics mentioned, including local resources for IPV and 
ST and referrals for mental health and substance use treatment within the VA and in the general 
community. If the participant desires, study staff will facilitate a consult to the appropriate 
mental health service within VA for further assessment and treatment. Study staff will also 
provide a warm hand-off to the Women Veterans Coordinators and Domestic Violence 
Coordinators as needed/desired. 
 
  
Informant interviews, open and randomized trials: After eligibility has been 
determined interviewers will review the appropriate Informed Consent forms for the next phase 
of the study in greater detail. The participant will be fully informed of the nature and extent of 
study participation, the objectives of the study, and the intervention to which they may be 
randomly assigned. Participants also will be informed of the fee payment structure that applies to 
the follow-up assessments they will complete following the treatment phase.  Interviewers will 
be trained to ensure that all participants comprehend the nature of the study and the wording of 
the consent form, and will provide a copy of the forms for potential participants to take home.  
 
After reviewing the consent form, the interviewer will ask potential participants to sign the 
informed consent form that corresponds to the appropriate phase of the study.  They will also be 
asked to sign a HIPAA authorization form.  
 
Measures 
(See appendix for measures) All assessments for this study will be completed on a 
laptop/tablet computer through web administration at in-person sessions held in women’s 
primary care or dedicated research space at the VA in Waco and Temple.  
Overview of assessments:  Standard instruments will be administered to gather demographic 
data and to assess key constructs of ST, PTSD, IPV, alcohol use, as well as resource and 
treatment utilization.  If other relevant constructs are identified in informant interviews, we will 
add measures to assess these constructs during the initial randomized control trial. Participants 
will complete screening assessments, and individuals randomized to the SHE intervention or SR 

11 
 
(control condition) will complete assessments at a 2- and 4-month follow-up.  One of the two 
research assistants who is not involved in recruitment will be available during the assessments 
and masked to the intervention condition.  If a participant is called for her medical appointment 
during her screening or assessments, the research assistant will offer to continue after her 
medical appointment or schedule a return visit.   
All assessments are well established, with adequate reliability and validity, well-matched to 
our program components and aims.  The baseline battery is designed to minimize assessment 
with the control group in order to take into account growing concerns regarding the motivational 
properties of assessment, leading to substantial Type II error in other MI-based intervention 
studies[100,101].  The baseline assessment will occur immediately following the consent 
procedures, and will be self-administered on a laptop computer. Items from the screening and 
baseline assessments that will be used to generate the personalized feedback report (PFR) used in 
the intervention modules are marked with an asterisk (*).  
 
Screening measures: As described above, the screener will include the following brief series 
of questions about general health and the following well-validated, reliable and recommended 
measures.  Lifetime ST will be assessed via the SES-SFV[83], items from the VA MST 
screener[84-86], as well as the CSVQ[87,88]. Specifically, the SES-SFV will assess experiences of 
unwanted sexual contact, sexual coercion, attempted rape and rape experienced from the age of 
14 to the time of the survey. The SES-SFV is commonly utilized in research of sexual trauma, 
and utilizes a series of 10 behaviorally-oriented and sexually-explicit questions to assess several 
types of victimization experiences. Prior research with the SES-SFV suggests that versions of the 
scale[102] demonstrate good test-retest reliability (r = .93)[103], and adequately captures the legal 
definitions of attempted rape and rape[104]. The quantity and frequency of alcohol use will be 
assessed during the screening using the Graduated Frequency Measure (GFM)[91]. An algorithm 
is utilized to quickly score the measure to determine whether the participant exceeds the national 
recommended limits[89,90] for daily drinking (4 or more for women) over the specified recall 
period.  Symptoms of PTSD will be assessed with PTSD Checklist for DSM-5 (PCL-5)[93]. 
Individuals will be classified as screening positive for current PTSD if the sum score is equal to 
or greater than 33 [92]. The PCL-5 is considered a “best practice” instrument in the assessment of 
PTSD.  At screening, IPV in the past year will be assessed with the Woman Abuse Screening 
Tool (WAST)[99], which was originally designed for use in primary care settings, is an 8-item 
instrument that measures physical, sexual, and emotional abuse in the last 12 months[93 and is 
consistent with the definition of IPV as defined by The American College of Obstetricians and 
Gynecologists[99,105]. It has correctly classified 100% of nonabused women and 92% of abused 
women in a known-group analysis[99], has good internal reliability[106], and has adequate 
concurrent validity[106].  Consistent with similar studies, IPV status is positive if a woman obtains 
a score of 4 or more on the WAST. 
 
Baseline and follow-up measures of ST: During the baseline assessment, further detail will 
be gleaned regarding the characteristics of ST experienced by study participants.  A series of 
follow-up questions will be administered following the SES-SFV to ascertain characteristics of 
the assault, including the age at the time of the assault and whether the assault occurred during 
military service,  (i.e., age 17 and younger, age 18 but before military service, during military 
service, after military service). The SES-SVF will also be administered at follow-up to assess for 
sexual victimization over the interim. 
  
Baseline and follow-up measures of alcohol use:   
Participants who screen eligible for the study, and enroll will complete additional measures 
of alcohol use at the baseline assessment. At baseline and at follow-up, alcohol use will be 
assessed with the 30-day Alcohol Timeline Follow back* (TLFB)[107], a calendar-assisted 
measure used to garner a retrospective account of drinking behavior. The TLFB will be used to 
calculate any vs. no heavy drinking (i.e. 4 or more drinks on one occasion during the past 30 
days) for primary study analyses.  At each follow-up point, the TLFB will assess substance use 

12 
 
since the previous follow-up point. The TLFB has excellent reliability[108] and validity for 
alcohol[109], and is sensitive to change as used in this study[107,110]. The TLFB is commonly 
utilized to provide feedback to participants regarding the quantity and frequency of alcohol use, 
and provide an estimation of blood alcohol content on average and peak drinking day.   
Problems associated with alcohol use will be assessed at baseline and over the follow-up 
using the Alcohol Use Disorder Identification Test (AUDIT)[111,112]. 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. The AUDIT was 
developed utilizing an international validation trial[111,112]. Shields and Caruso’s (2003)[113] 
examination of the reliability of the AUDIT across 24 studies suggests that the median internal 
consistency of the AUDIT is high. Test-retest reliability of the AUDIT is reported to be high (r 
=.86)[114]. Construct validity for the scale is demonstrated through high correlations with the 
Michigan Alcohol Screening Test (r=.88)[115].  Participants will also complete the Readiness to 
Change Questionnaire (RCQ)[116], which implements the trans-theoretical model of change to 
assess readiness to change drinking habits. The RCQ is a 12-item assessment that was developed 
to measure a drinker’s stages of readiness to change that could be used in conjunction with brief 
interventions within medical settings. Reliability and validity of the RCQ is well 
documented[116].  This assessment will be administered at baseline for inclusion in the 
personalized feedback form, as well as over the follow-up to examine facilitation of readiness to 
change as a function of intervention participation. 
 
Baseline and follow-up assessments of IPV: : The Composite Abuse Scale (CAS[118,119]) will 
assess the chronicity and occurrence of violence with their current partner (over the past year).  
At subsequent assessments it will be administered for the time since last assessment.  The CAS, a 
widely used self-report of behaviors, has 30 items presented in a six point format requiring 
respondents to answer “never”, “only once”, “several times”, “monthly”, “weekly” or “daily”-over 
the specified time period.  The CAS has 4 subscales that measure severe, combined abuse, 
emotional abuse, physical abuse, and harassment.  The CAS has recently been published in the 
Centers for Disease Control and Prevention compendium of intimate partner violence measures.  
The scale will be coded categorically (no violence vs. any on one or more CAS subscales of 
combined abuse, emotional abuse, physical abuse, and harassment) for the primary study 
analyses. The scale will also permit exploratory analyses of decreasing the frequency of violence 
among participants.   
The 15-item checklist the Safety-Promoting Behavior Checklist (SPBC) will be used to 
assess the participant’s use of strategies that could protect her from IPV in the future (e.g., hiding 
money and extra clothing)..  All questions begin with the phrase, “Have you ever . . .” followed 
by specific safety-promoting behaviors.  In subsequent assessments the same series of questions, 
it will be administered for the time since last assessment.  The SPBC has been used successfully 
in interventions for women with IPV that have like SHE targeted an increase in safety 
behaviors[120,121].  
Assessment of PTSD symptoms:  Symptoms of PTSD will be assessed over the follow-
up with the PCL-5*[93-98]. To assess for the occurrence of other forms of trauma, at baseline and 
at follow-up participants will complete the Trauma History Screen (THS)[122]. The THS is 13-
item self-report measure that examines 11 events and one general event, including military 
trauma, sexual assault and natural disasters. For each event, respondents are asked to indicate 
whether the event occurred ("yes" or "no") and the number of times it occurred. Addition items 
assess age at the time of the event, whether there was actual or a threat of death or injury, 
feelings of helplessness and feelings of dissociation, a 4-point scale for duration of distress ("not 
at all" to "a month or more") and a 5-point scale for distress level ("not at all" to "very much"). 
The THS is written for a low reading level and is commonly utilized in research. The THS will 
be administered at baseline and at follow-up (with reference to the interim period) to aide in 
classifying participants according to DSM criteria for PTSD.  

13 
 
 
Assessment of treatment utilization:  Utilization of treatment will be assessed with 
questions from an adapted Treatment Services Review (TSR).[123]  Utilization of community 
resources and VA resources will be assessed with questions from an adapted Effectiveness in 
Obtaining Resources Scale (EOR). The EOR 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[124].  The EOR has been successfully used in 
research evaluating the efficacy of advocacy services for women with interpersonal violence[125]. 
In addition to assessing actual use of treatment resources, we will also examine whether the 
intervention is associated with changes in perceptions of treatment resources through the 
Attitudes towards Seeking Professional Psychological Help Scale—Short Version (ASPH)[126]. 
Participants respond to items such as, “I would want to go to a therapist if I were worried or 
upset for a long period of time” along a 4-point scale, ranging from “disagree” to “agree”. Higher 
scores are indicative of more positive attitudes towards seeking psychological care. Adequate 
reliability and validity of the scale are reported across several studies[127-129].  
For participants in the trial, we will also conduct a chart review using the VA 
Computerized Patient Records System to assess for mental health appointment attendance before 
and after the trial. This will entail documenting the number of mental health appointments 
attended at VA 4 months before the trial and 4 months after. The purpose of this information is 
to objectively document whether SHE increases engagement in VHA mental healthcare. 
 
  
Assessment of acceptability:  Satisfaction with CIAS Software Scale (SCSS)[130] 
assesses participant satisfaction on items tapping on likeability, ease of use, level of interest, and 
respectfulness using a 1 – 5 Likert scale (1 = low, and 5 = high). This scale will be administered 
after every SHE module.  The Client Satisfaction Questionnaire (CSQ) is an 8-item questionnaire 
which assesses the participant’s satisfaction with the intervention[131].  The scale has good 
psychometric properties and correlates highly with other intervention measures [124,132,133].  Only 
participants in SHE will complete these two measures immediately after the intervention. 
 
 
Measures of family and relationship functioning: Prior research on Veterans has 
suggested that family and relationship functioning may influence treatment engagement, 
therefore we will include such measures as a covariate in analyses and to examine how family 
functioning may predict treatment completion, appointment attendance. The Quality of Marriage 
Index (QMI; Norton, 1983) will be used to assess relationship distress (6 items). The Family 
Assessment Device 12 (FAD; Epstein, .Baldwin, Bishop) is a brief measure of general family 
functioning. 
 
Table 1:  Schedule of Assessment Measures 
 
Schedule of Assessments 
 
 
 
 
Screening Baseline 
2-
month 
4-
month 
 
 
 
 
Measure Purpose 
SHE 
Contro
l 
SHE 
Contro
l
SHE 
Contro
l
SHE 
Contro
l
ST 
 
SES-SFV+MST 
screener 
 
X 
X 
 
 
X 
X 
X 
X 
Screening 
CSVQ 
X 
X 
 
 
 
 
 
 
Screening 
h
o
GFM 
X 
X 
 
 
 
 
 
 
Screening 

14 
 
TLFB 
 
 
X 
X 
X 
X 
X 
X 
Primary Outcome and 
Feedback 
RCQ 
 
 
X 
X 
X 
X 
X 
X 
Attitude Change  
AUDIT 
 
 
X 
X 
X 
X 
X 
X 
Exploratory Analyses 
IPV 
WAST 
X 
X 
 
 
 
 
 
 
Screening 
CAS 
 
 
X 
X 
X 
X 
X 
X 
Primary Outcome  
SPBC 
 
 
X 
X 
X 
X 
X 
X 
Attitude Change  
PTSD 
THS 
 
 
X 
X 
X 
X 
X 
X 
Primary Outcome 
PCL-5 
X 
X 
 
 
X 
X 
X 
X 
Primary Outcome and 
Screening 
Tx Use 
EOR 
 
 
X 
X 
X 
X 
X 
X 
Primary Outcome 
TSR 
 
 
X 
X 
X 
X 
X 
X 
Primary Outcome 
ASPH 
 
 
X 
X 
X 
X 
X 
X 
Attitude Change 
Acceptabili
ty
SCSS 
 
 
X 
 
 
 
 
 
Treatment Acceptability 
CSQ-8 
 
 
X 
 
 
 
 
 
Treatment Acceptability 
y
lationship 
Functioni
QMI/ FAD-12 
 
 
X 
X 
X 
X 
X 
X 
Secondary 
outcomes/covariate 
 
Retention  
 
Participants will be considered non-completers if they do not attend all modules of the 
intervention commensurate with their risk profile.  Careful efforts will be made to minimize 
attrition, and pilot work will identify and address barriers to study participation. To maximize 

15 
 
retention, research staff will attempt to make regular contact with subjects to collect data at each 
assessment interval, regardless of whether they completed the intervention. Contact information 
will be recorded at baseline.  Women will have the opportunity to complete modules of the 
intervention at a time of their choosing over a one-week period.  As needed and appropriate, 
women who experience barriers to traveling to the VA to complete follow-up assessments (e.g., 
no childcare, travel distance, etc…) will have the option of completing follow-up assessments 
over the phone with a study staff member.   
 
Compensation 
Screening:  Every participant that take part in the screener will be compensated $10 in 
the form of a gift card to a local store after completing screener.  Every participant will also be 
eligible to be entered in a drawing.  One out of every participant that is screened will be 
randomly selected for a $100 gift card.   
Informant Interviews:  Participants that take part in the informative interviews will 
receive a $30 gift card.  
Open trial:  Participants in the open trial will be compensated $30 in the form of a gift 
card to a local store at the end of their first assessment. Then will receive a $40 gift card for the 
completion of the 2-month assessment and a $50 for the completion of the 4-month assessments.  
If they complete all computer delivered interventions sessions and follow-up assessments, they 
will receive an additional $30 gift card at the completion of the 4-month assessment.  They will 
receive for the interview at the end of the SHE intervention, an additional $30 gift card.  In total 
for completing all assessment and exit interview participants will be compensated up to $180 in 
gift cards. 
In addition, they will be given a $5 gift card for each assessment that is not rescheduled.  
If they return 2 postcards that are sent which ask them to confirm their current address, they 
receive $5 gift card for each postcard that they send back. In total, they will be compensated up 
to $205 in gift cards. 
Randomized trial:  Participants in the randomized trial will be compensated $30 in the 
form of a gift card to a local store at the end of their first assessment. Then will receive a $40 gift 
card for the completion of the 2-month assessment and a $50 for the completion of the 4-month 
assessments.  If assigned to the SHE Intervention and complete all SHE sessions and follow-up 
assessments they will receive an additional $30 gift card at the completion of the 4-month 
assessment. If not assigned to the SHE intervention, but complete all three assessments, 
participants will receive an additional $30 gift card after the completion of the 4-month 
assessment.  In total for completing all assessment (and SHE intervention sessions if assigned to 
SHE), participants will be compensated up to $150 in gift cards. 
In addition, they will be given a $5 gift card for each assessment that is not rescheduled.  
If they return 2 postcards that are sent which ask them to confirm their current address, they 
receive $5 gift card for each postcard that they send back. In total, they will be compensated up 
to $175 in gift cards. 
 
Overview of Participant Remuneration by Phase 
Screening 
Informant  
Interview 
Open Trial 
($205) 
RCT 
($175) 
$10 gift card; Entered 
into drawing for $100 
gift card 
$30 gift card 
$30 complete first 
assessment 
$30 complete first 
assessment 
 
 
$40 complete two 
month assessment 
$40 complete two 
month assessment 
 
 
$50 complete 4 month 
assessment 
$50 complete 4 month 
assessment 
 
 
Full completion all 
assessments – bonus 
Full completion all 
assessments – bonus 

16 
 
of $30  
of $30  
 
 
Exit interview $30 
 
 
 
$ 5 bonus each 
assessment not re-
scheduled 
$ 5 bonus each 
assessment not re-
scheduled 
 
 
$5 return postcard 
$5 return 2nd postcard 
$5 return postcard 
$5 return 2nd postcard 
 
 
 
 
Section 4. Treatment and Procedures 
 
Informant interview procedures 
(see appendix for sample questions) The goal of this component is finalize intervention content 
and procedures. The informant interviews will explore such issues as the women’s perceptions of 
the relationship between sexual trauma, alcohol use, IPV, and PTSD symptoms, and barriers to 
accessing care. Comfort in using technology will also be assessed, as well as ways to make 
intervention components interesting and user-friendly. Information will be used to assist us with 
the development of SHE.  
women will be scheduled to participate at a mutually convenient time and these interviews will 
be conducted in research space at the Waco or Temple VA medical centers.  
 
Interviews will be recorded and the recordings will be transcribed verbatim by the research 
assistant, all individual identifiers removed, and transcripts corrected for accuracy. Each interview 
will be reviewed again in order to edit any incorrectly transcribed text. After the recording is made 
it will be transferred to the secure research W drive for transcription and then the original 
recording on the digital recorder will be deleted. 
 
Coding: A coding guide will be developed through a carefully documented and iterative process. 
First, PI’s Creech and Zlotnick will create a proposed coding structure based on the original 
interview questions. Second, transcripts will be coded independently by at least 2 coders (PI and 
research assistant) to generate additional and/or refined codes within the coding structure. This 
process will continue with additional transcripts in an iterative fashion until the coding structure is 
well defined. All revisions to the coding structure will be documented. Third, once the coding 
structure is solidified, all transcripts will be double coded independently by 2 coders (PI and 
research assistant) who will meet to discuss their coding, resolving any discrepancies. Transcript 
coding takes approximately 2 hours per transcript, followed by an in-person meeting to reach 
concordance of codes. Formal Analyses for Themes and Content Using NVivo: The coded 
transcripts will be entered into NVivo qualitative management and analysis software. Once the 
codes are entered into NVivo, PI Creech\Zlotnick will summarize themes and responses for 
presentation and publication.  
 
Randomization (RCT only) 
The computer program will randomly assign participants to condition and the research assistant 
will remain blinded. 
 
SHE Intervention (open trial and RCT) 
As stated previously, this study will develop and test a brief modular, computer-based 
intervention that will target interrelated health risks for women Veterans with lifetime ST (i.e. 
alcohol misuse, IPV, and PTSD). In the proposed study, the SHE intervention will be specifically 
tailored, innovative and relevant to a diverse, group of Veteran women in a number of ways 
including the images and content used in the intervention. The computer-assisted self-interview 

17 
 
(CASI) software to be used in this study is unique in many ways. It is highly interactive and 
individualized, incorporates visual feedback, involves synchronous interactivity, presents 
questions one item at a time using a visually attractive screen and provides only the most 
pertinent information for the participant. Pleasing and culturally-sensitive graphics change with 
each screen to help maintain interest.  The use of headphones and spoken text allows the 
computer to be accessible to those at any literacy level, and provides a confidential setting 
regardless of study location.   
The content of SHE will be theory-driven, consistent with the MI model of behavior change, 
and consistent with the literature on effective interventions for our target population and targeted 
risk factors.  Motivational Interviewing (MI), a well-defined intervention approach, has wide 
dissemination, and demonstrated efficacy across a range of behavioral areas and across a range 
of settings, including primary care clinics[4,134,135].  MI involves the facilitation of internal 
motivation to change through alignment of behavior change with deeply held beliefs, values, and 
goals.  Consistent with the Transtheoretical Model (TTM)[136], MI utilizes stages and processes 
of change, evolving readiness and self-efficacy to change.  Ambivalence about change is 
considered normative within the motivational interviewing framework. The client’s readiness to 
make changes is not assumed. Instead, an important exercise in MI is the exploration of level of 
readiness to change. Therefore, the intervention is appropriate for varying levels of readiness to 
change.  
The MI model is of particular value for women with ST in reducing their risks because MI 
has a non-confrontational and collaborative approach, emphasizes increasing a participant’s 
awareness to successful steps towards their own well-being, identifies participant’s strengths, 
and builds upon participant’s successes, which is in keeping with the empowerment model, a 
highly recommended intervention for survivors of interpersonal violence[137].  In fact, recently, a 
workgroup[7] suggested that the empowerment model for women with interpersonal violence and 
MI models converge around important principles, such as increasing autonomy, self-efficacy, 
and skill sets.   
Some aspects of these therapies are difficult to translate literally into a computer-based 
intervention (e.g., empathy). The software relies heavily on realistic interactions with a three-
dimensional animated narrator to mimic the empathic, conversational nature of person-delivered 
brief, motivational interventions. Throughout the development phase of the study, we will 
receive feedback on participants’ sense of autonomy, of being supported and reinforced in their 
decisions, and of the tone of the module.  Further, Dr. Daniel Squires (consultant), who has 
experience with computer-based interventions and experience in methods of translating 
traditional therapies to the person-computer interface will provide input on how best to present 
the MI intervention.  The software, including the three-dimensional animated narrator, has been 
found in previous research to be well-understood and well-liked by women[75,130].  
The investigators’ experience with empirically tested programs that address alcohol 
use[75,138,139], IPV[76], and/or PTSD[76] will also inform the development of SHE.  More 
specifically, regarding brief MI-based interventions for alcohol, Dr. Kahler has developed and 
tested MI based interventions that address heavy drinking[138]  and alcoholism[139].  Dr. Tzilos has 
adapted the proposed study software to screen and intervene with alcohol misuse in a sample of 
urban, high-risk pregnant population[75].  Dr. Zlotnick has successfully developed and tested 
empowerment based interventions for women with IPV[76] and women with PTSD[76]. Dr. Creech 
is an expert in mental health and sexual trauma among women Veterans and women Veterans 
issues, as well as in intimate partner violence among Veterans and military populations.  
All SHE sessions will take place within the primary care clinic setting or designated research 
space and consist of three computer delivered intervention modules, each designed to be 
completed in approximately 30 minutes and tailored to the current risk profile of each 
participant.  The first intervention module will take place after the baseline assessment and 
remaining modules, if needed, will be given at a session within one week after the first session.  
Each module will be designed so that it can be administered individually, or in tandem with the 
other modules. Women will complete only the modules aligning with their risk profile. During 
the development phase, we will explore various orderings of the modules (i.e., alcohol module 

18 
 
prior to IPV module) so that all women receiving more than one module receive the information 
in the same order.  
At the beginning of each SHE module, a narrator will first introduce the session in an 
empathic, concerned, non-authoritarian, and nonjudgmental conversation. After providing an 
overview of the session and establishing rapport, each intervention module will begin with a 
baseline assessment of the risk factor. Participants will then receive immediate “profiles” 
(personalized feedback) based on their answers to baseline assessments. For instance, for IPV a 
relationship profile will summarize participant’s relationship safety including information about 
the types and severity of IPV experienced (The Composite Abuse Scale; ; CAS[118,119]).  For 
alcohol use, part of the personalized feedback will include the Drinker Inventory of 
Consequences (DrInC)[117] to provide feedback on alcohol use consequences and the Brief 
Drinker Profile[140] to provide feedback regarding family history and risk for alcohol dependence.  
Next there will be an education component that will 
briefly deliver facts about the risk: For instance, educational 
information on alcohol will be provided regarding alcohol 
use among women Veterans, prevalence, especially among 
women with ST, and risks, including IPV.  For PTSD, the 
educational component will include prevalence among 
women Veterans, symptoms, causes including MST and 
combat exposure, and negative consequences of PTSD, 
including alcohol risk, and revictimization.   
Next, participants will indicate their readiness to 
change.  For alcohol use, women will be asked, “are you 
willing/ready to quit?” which would lead to a bifurcated 
treatment response such that those participants reporting a 
goal of immediate abstinence will move more quickly to a 
section consistent with primarily goal-setting. Those who do 
not wish to quit will be queried regarding their interest in 
cutting down (i.e., reducing the quantity/frequency of 
drinking), and/or reducing the number of negative consequences associated with drinking. Those 
participants that are currently not interested in or are ambivalent about changing their alcohol use 
will receive elements including pros/cons and normed feedback.  Computer software can easily 
deliver such a bifurcated treatment approach – such an intervention design is consistent with 
evidence that motivational approaches may work best with less motivated individuals[141].  For 
the IPV and PTSD modules, participants will indicate their readiness to utilize relevant resources 
(e.g., seek mental health for PTSD, remain in treatment, or re-engage in treatment, use IPV 
hotlines, talk to health care providers and/or support person about IPV/PTSD and IPV/PTSD 
resources), and the intervention will be tailored on the readiness of each participant. Consistent 
with MI, those reporting a goal of readiness to utilize resources will move more quickly to a 
section consistent with primary goal-setting which will include affirmations about utilizing 
resources, and encouraging the use of formal and informal social supports for maintenance of 
gains as well as self-care strategies; those who are not ready will receive elements including 
pros/cons and normed feedback.    
At the end of each module, there will be video clips inserted of women Veterans with the 
particular risk factor, discussing ways in which they were able to reduce their risk, such as access 
care/resources, remain in treatment, and/or implement strategies to reduce the risk of IPV, and/or 
increase formal and informal support and self-care strategies.  Each module will have a selection 
of videos that will be tailored to the woman Veteran’s profile.  For instance, for women Veterans 
with PTSD who are in treatment, there will be a video clip of a women Veteran with PTSD 
discussing how treatment has helped her, and discussing ways in which she has increased her 
support system as well as self-care strategies.  Participants will then have the option to create a 
personalized Safety Plan.  Participants will select from a menu of potential personal change 
goals relevant to each risk module (e.g., reduce frequency or quantity of alcohol use; stop alcohol 
use; implement x% of a safety plan for IPV; implement complete safety plan) or optionally, can 
Assessment
Personalized
Feedback
Education
Readiness to Change
Yes?
No?
Goal-setting
Pros & Cons
Safety Plan

19 
 
enter their own change goals in free text.  Participants will be provided with an optional one-
page print-out of the Safety Plan as a resource. 
Format and Design of the Intervention: SHE will be created for use on a laptop computer 
using Dr. Steven Ondersma’s Computerized Intervention Authoring Software (CIAS)[142,143]. Dr. 
Tzilos (Co-I) has been trained by Dr. Ondersma to use this software and has conducted a pilot 
clinical trial (AA016256) whereby she specifically adapted this software to screen for and reduce 
alcohol use in women[75].  The CIAS software is highly individualized, and involves synchronous 
interactivity, and relies heavily on realistic interactions with a three-dimensional animated 
narrator to mimic the empathic, conversational nature of person-delivered brief, motivational 
interventions. Moreover, this software incorporates visual feedback, presenting questions one 
item at a time using a visually attractive screen that provides only the most pertinent information 
for the participant.  We will also work with a graphic designer to create intuitive and engaging 
pages and to guide media production for video vignettes specific to women Veterans and audio-
instruction.  
 
Control (RCT only) 
The control condition will involve screening and referral only. Patients will be provided with at 
least referrals to mental health treatment. If the participant desires, study staff will also facilitate 
a consult to the appropriate mental health service within VA for further assessment and 
treatment. Study staff will also provide a warm hand-off to the Women Veterans Coordinators 
and Domestic Violence Coordinators as needed/desired. 
 
Data Analysis 
Overview of data analysis: Dr. Kahler will provide expertise with regard to statistical, 
research, and data management methods for the study.The sample size of the study allows good 
power to detect effects of approximately medium magnitude.  Smaller effects may not reach 
significant, but can provide valuable data on likely effect size ranges for planning a larger scale 
trial.  A small set of primary outcomes were selected with the goal of reducing Type I error and 
examining preliminary intervention effects. Data collected during the open pilot trial and initial 
randomized control trial will be analyzed separately. Preliminary analyses will include studies of 
patterns of missing data, dropout rates, and correlations among outcome measures.  We will 
identify the appropriate distributional models for dependent variables. Continuous variables 
showing significant skew or kurtosis will be transformed.  Using an-intent-to treat sample, 
comparisons between SHE and SR groups will be conducted using general linear models with a 
logistic regression model for our main outcome (number of risks).  Using a general linear model 
we will also examine differences between the two conditions in terms of utilization of medical, 
psychological, and IPV-related services/resources at the two and four month follow-up period 
(secondary outcome).   
 
Data checking: Participants’ data will be directly exported from CIAS to a database that 
is under the VA firewall immediately after each participant session. All data will be screened for 
missing data, outliers (Z > 3.29), and distribution abnormalities, with log transformation as 
needed. We will compare treatment groups on baseline characteristics (e.g., demographics). 
Analyses will adjust for baseline levels of dependent variables but will not test or adjust for any 
other baseline differences between conditions that result from randomization. Missing outcome 
data can create problems with the analysis and interpretation of intervention outcomes. We will 
conduct analyses to determine degree of attrition bias, and any variables shown to be associated 
with attrition will be included in the analytic models.  Analyses will be based on all available 
data. 
 
Feasibility acceptability of intervention and study procedures (Open trial): To assess 
the clarity, structure, content, and acceptability of the intervention we will assess the total 
intervention completion rate, retention rate, participant session ratings and total treatment 
acceptance scores gathered during the Open Trial. We will not have a comparison group for 

20 
 
participants in the open trial; however, we will examine rates of alcohol use, PTSD symptom 
severity, IPV occurrence and treatment/resource utilization at 2-months and 4-months post 
baseline.  We will also examine women’s immediate post-intervention ratings of the SHE 
intervention to explore the perceived utility of various program components (see appendix for 
exit interview questions).   
 
 
Study and treatment feasibility/acceptability (Aim 3): Feasibility of the SHE 
intervention will be assessed by examining rates of session attendance, rates of 
treatment/assessment completion, rates of dropout, and reasons for termination.  We will assess 
acceptability of the intervention via self-reported ease of use, helpfulness, and overall 
satisfaction using the SHE participants’ responses from the Satisfaction with CIAS software 
scale[130] and from the CSQ[131]. We will examine means, modes, and median scores for these 
measures.   
Feasibility of the research procedures will be assessed by examining study recruitment 
rates, refusal rates, follow-up rates and participants’ willingness to be randomized. For follow-up 
retention rate (dichotomous), a chi-square analysis will be used.  An urn randomization 
procedure will be utilized to avoid group differences at baseline. The success of random 
assignment in equating groups on baseline characteristics will be assessed.  This will involve 
comparison of groups on demographic characteristics and number of risks. Should groups differ 
on any variables that show a relation to outcome, outcome analyses will be conducted both with 
and without adjusting for these covariates. 
Primary outcomes (Aim 4a):  Following the intention-to-treat principle, all women who 
completed the baseline assessment and who are randomized will be included in the analyses. 
Analyses will first test the hypothesis that SHE reduces the number of risks relative to control. 
Quantification of post-intervention behavioral change will be estimated by comparing the 
distributions of the number of risks in the two groups at baseline and follow-up. Within-person 
changes in the number of risks over time will also be examined. Specifically, women will be 
characterized by the number of risks (one through 3) at baseline. That will serve as a covariate in 
a model predicting number of risks at 2 and 4 months, which will be analyzed using generalized 
estimating equations (GEE) with a Poisson distribution specified.  GEE is a method of repeated 
measures analysis commonly utilized for binary outcomes that allows for the inclusions of both 
categorical and continuous independent variables, as well as appropriate modeling of covariates 
when observations are correlated across time. The primary between group independent variable 
will be program group; dummy coded using the intervention as the reference category.  
To further illustrate program effects, each of the participants will then be classified over 
the follow-up as 1) resolving all risks; 2) resolving some but not all risks; and 3) resolving no 
risks or increasing the number of risks.  Intervention effectiveness will be measured by 
comparing the proportion of women resolving all risks, to the proportion of women resolving no 
risks or increasing risks between the groups. The proportion of women resolving all risks will 
also be compared to the proportion of women resolving some risks between groups.  
Secondary outcome (Aim 4b):  Analyses will also examine comparisons between 
groups in the extent of change in use of treatment (TSR and CPRS number of mental health 
visits) [123] and resource utilization (EOR[124]) (secondary outcome) as well as the extent of 
change on individual risk factors overtime using generalized estimating equations (GEE) (i.e., 
occurrence of IPV as measured by the CAS[118,119], screen positive for PTSD diagnosis as 
measured by the cut point of  ≥33 on PCL-5[93], heavy drinking status as measured by the 
TLFB[107]).   
Analyses will also examine comparisons between groups in the extent of change in use of 
treatment (CPRS number of mental health visits and TSR)[123] and resource utilization (EOR[124]) 
as well as explore change in individual risk factors using (i.e., extent of alcohol use 
(AUDIT)[111,112], severity of PTSD symptoms (PCL-5[93]), frequency of IPV (CAS[118,119])  using 
GEE.  Outcomes of treatment and resource utilization, IPV, PTSD and alcohol use will be 
classified as continuous dependent variables. Scores from the outcome variables at follow-up 
will serve as the dependent variables. Intervention group will serve as the independent variable. 

21 
 
We will also calculate effect sizes for treatment efficacy for the aforementioned continuous study 
outcomes by examining the difference between the estimated adjusted means of the two groups 
at the end of the study divided by their standard deviation. 
Supplemental analyses: In light of the challenges in promoting behavior change within 
treatment studies, we have included a limited number of assessments in order to promote 
analyses of the whether the intervention is associated with changes in the attitudes and beliefs 
that may serve as a mechanism of behavior change. Towards this goal, we will explore whether 
participants in SHE, relatively to control, vary in their attitudes towards seeking psychological 
care (ASPH), readiness to change drinking behavior (RCQ), and safety behaviors (SPBQ). These 
analyses will test whether SHE increases the mediators, whether the mediators are associated 
with the related behavioral outcomes, and whether there is a significant indirect effect of SHE 
through each mediator. We will use the products of coefficients method to test for 
significance[144] of the indirect effects. 
Power Analysis: Given the developmental nature of this study, our primary objective 
will be to determine a reasonable effect size for the SHE intervention for planning a future 
randomized trial, rather than to determine statistical significance between groups.  Sample size 
requirements were estimated based on having adequate power to find clinically meaningful 
effects of the intervention on each of the primary outcomes, including reducing the percent of 
participants who screen positive for the health risk of PTSD, while also acknowledging the need 
to maintain a modest sample size in the initial test of a novel treatment approach. As documented 
below, we determined that an initial sample size of no more than 155 would meet these goals. 
Research conducted by Himmelfarb and colleagues (2008)[145] indicated that 
approximately 60% of VA women who screened positive for MST indicated PTSD. Given that 
we will identify women not only with MST, but a lifetime ST, we conservatively estimate that 
60% of women included in the study will screen positive for PTSD. With an initial sample of no 
more than 155 women, retaining 126 over the 4-month follow-up, power would be .80 to detect 
an effect size h of .53 (equivalent to a medium effect size), with an alpha of .05, over the 4-
month follow-up.  This would be achieved, for example, with rates of PTSD at follow-up of 34% 
in the program vs. 60% in control.  
The sample size of no more than 155 women would also be sufficient for detecting 
changes in the proportion of women indicating an alcohol use problem or occurrence of IPV over 
the follow-up.  Based on findings suggesting that 7-14%[16,146] of VA women with MST report 
SUD, and 64%[147] of women with any lifetime sexual abuse report alcohol abuse, we 
conservatively estimate that 40% of women included in the study will screen positive for alcohol 
problems. Thus, the sample of no more than 155 accounting for attrition would allow a power of 
.80 to detect an effect size h of .44 of changes in alcohol use problems over the follow-up. This 
would be achieved with rates of alcohol use problems of 20% vs. 40% in control. Further, based 
on data indicating that 33%[148] of women with a history of sexual victimization are revictimized, 
44% of active duty military women report lifetime IPV[149], and studies indicating that IPV 
revictimization ranges from 18% to 74% [150,151]over  6- to 9-month follow-ups (see Kuijpers et 
al., 2011[152]), we conservatively estimate that 40% of women with a history of lifetime ST 
presenting at the VA would report lifetime IPV, and 25% would report a revictimization 
experience over the 4-month follow-up. A sample of no more than 155 accounting for attrition 
would allow a power of .80 to detect an effect size h of .46 in changes in IPV revictimization 
over the 4-month follow-up. This would be achieved with rates of IPV revictimization of 8.5% in 
the SHE program vs. 25% in the control group. 
The sample size of no more than 155 will also be sufficient for detecting changes in the 
proportion of women who reduce the number of risks over the follow-up. Among the full sample 
of no more than 155 women, power would be .85 to detect an effect size h of .44 in any 
reduction (i.e., 1 to 0 risks, 2 to 1 risk, 3 to 2 risks, etc.) in the number of risks; which would be 
achieved, for example, with 20% of women in control and 40% of women in SHE reducing the 
number of risks reported over the follow-up. Power would also be adequate to examine 
reductions in the number of risks among women experiencing various numbers of risks (i.e., 
women reporting 1 risk vs. 2. vs. 3). In light of high comorbidity between PTSD, IPV, and 

22 
 
substance use, we projected that 50 women will report 1 risk, 50 women will report 2 risks, and 
50 women will report three risks.  Thus, among women reporting each number of risks (i.e., we 
expect 50 women will report 1 risk), power would be .73 to detect an effect size h of .64, which 
would be achieved with 20% of women in the control group reporting a reduction, and 50% of 
women in SHE reporting a reduction.  
Limitations The limitations of this study include: potential issues related to disclosure of 
sensitive information, the use of self-report, assessment reactivity and effect on measured 
outcomes, the inclusion of only English-speaking participants, generalizability of study results to 
other Veteran or service member populations, and an inability to meaningfully examine 
ethnic/racial differences in the proposed sample. 
 
Revision:  Based upon experience during the Development and Trial Phase, evaluation of the 
program, and feedback from participants, the Investigator Team will revise the intervention. 
Information regarding the recruitment methods and retention of participants will be utilized in 
the design of a later clinical trial. This final revision phase will generate the final “product” of 
this treatment development study, to be used in the application to evaluate SHE in a large-scale 
clinical trial. 
 
Section 5. Privacy and Confidentiality 
  
Data Management: 
Identifiers: Given the sensitive nature of this research, the computer software will 
simply generate a code number for each participant.  Data will only be identified with the study’s 
ID of the participant. Participants will complete the assessments on a VA issued laptop or tablet. 
Confidentiality: All paper forms (informed consent; HIPPA) with participant 
information will be marked with a code number and not with the participants’ name. PI Creech 
and approved CTVHCS study staff will keep the link between the participant code number and 
name in a password protected master file separate from coded data on the Central Texas secure 
research (W) drive. The paper files will be stored in locked file cabinet in a locked room at the 
VHA VISN 17 Center of Excellence in Waco, TX. 
No participant will be identified in any publications or presentations arising from this 
study. Records will be maintained in accordance with the Department of Veterans Affairs Record 
Control Schedule 10-1. It may be necessary or required for the study investigators to break 
confidentiality and release personal identifiers and health information when mandated by law. 
For example, state law requires health care workers to report any suspected abuse or neglect of a 
child, or person 65 years or older, or an adult with disabilities to the Texas Department of Family 
and Protective Services.  
A Certificate of Confidentiality will be obtained from the National Institutes of Health 
prior to the commencement of research. The purpose of this certificate is to protect the identity 
of research subjects participating in studies that collect sensitive information. No information 
about participants will be released without their permission or where required by law (such as the 
examples given above).  All employees who are to handle data will be trained in confidentiality 
policies and procedures. In the event that theft, loss, or other unauthorized access of sensitive 
data and non-compliance with security controls occur, study staff has been instructed to follow 
the CTVHCS standard operating procedure on incidence reporting. 
Disposition of the data: Paper files containing identifiers will be kept in locked file 
cabinets in a locked room at the Center Of Excellence in Waco, TX. Coded paper files will be 
kept in separate locked file cabinets. Only approved study staff will have access to the files. 
Electronic data will be stored on the secure VA password-protected server with access restricted 

23 
 
to research staff.  Records will be maintained and retained in accordance with the Department of 
Veterans Affairs Record Control Schedule 10-1. 
Incident Reporting: Any incidents affecting the security of the data such as theft, loss, 
or unauthorized access of sensitive data will be reported to the ISO and PO per VA regulations. 
Section 6. Technical Specifications 
 
Survey/Intervention Administration: Study assessments and intervention sessions will occur 
only through web administration at in-person sessions held in women’s primary care or 
dedicated research space at the VA in Waco and Temple. We will use the Computerized 
Intervention Authoring Software (CIAS), developed by Dr. Steve Ondersma, and licensed 
through Interva, Inc. The Computerized Authoring Intervention Software (CIAS) is a 
sophisticated web-based program designed to allow development and modification of computer-
delivered assessment and intervention modules for research studies. This software utilizes SSL 
technology for encrypting of communications between remote computers and the server itself, 
and is currently used in a number of major NIH-funded research studies. A license to use the 
CIAS system will be purchased by grant funds, and no software or data will be downloaded to 
the VA issued laptop/tablet. 
 
To access the system, investigators and study staff will utilize Kiosk Mode on study laptops or 
tablets, which will limit participant computer access to a unique and non-searchable FIPS 140-2 
compliant study website. Each participant will be set up with the day’s screening, assessment or 
intervention session using only software-generated unique and non-identifying user IDs. No 
protected health information will be entered into the surveys or interventions. 
 
The intervention and assessment sessions will be constructed by project staff affiliated with the 
parent site in Providence, RI.  
 
Identifiers/linking data: 
No IP addresses or other electronic identifiers will be recorded. Participants will not enter their 
name or any other identifying information or PHI into the web site.  All data storage devices, 
will be VA issued and monitored by information management services. Only study personnel 
authorized by the Principal Investigator (PI) will have access to the data, and the file server is 
protected from the internet by a firewall.  
 
A password protected master participant tracking spreadsheet will contain the linking 
information that matches the unique participant IDs to participant names. This spreadsheet will 
reside only on the secure research W drive. Other PHI such as participant addresses and phone 
numbers (for follow-up contact), and date of participation will be contained in the master tracker. 
This information will only be accessible to PI Creech and her research staff that is approved to 
work on the study. 
 
Data Retrieval: Data collected through the CIAS system resides on a firewall-protected server 
in Southfield, Michigan that uses AES-256 encryption in transit. All data will be downloaded 
from the CIAS server on a weekly basis and stored in a password protected file on the secure 
central Texas VA research server (W drive) in a restricted folder (e.g. W:\Research 

24 
 
Projects\Creech ). The progress of participants will be closely monitored to ensure that each 
subject record is erased as quickly as possible.  Any staff no longer associated with the study will 
have access to the study files removed. 
 
Data Transfer:  
For each participant at the first study visit, the most data to transport would be the informed 
consent documents for the study. For the interview phase of this study, this will also include 
recordings of interviews conducted. Study data collected at the Temple campus (informant 
interviews recordings) will be transported to the approved data storage location at the Waco 
Campus where it will be uploaded to the secure research W drive. Personally identifying 
information (e.g. Informed Consent Form with name and date of consent) will be kept in a 
separate locked carrying case from the data during transport. No other paper data is collected as 
part of this study. The digital recorder used will be FIPS 140-2 compliant.  
 
De-identified data encrypted via FIPS 140-2 will be transferred to other institutions for data 
analysis (e.g. Women and Infants Hospital and Brown University) through UPS with a chain of 
custody. Listed are the following people and addresses that de-identified data will be sent to: 
 
Caron Zlotnick 
Butler Hospital 
345 Blackstone Blvd 
Providence RI 02906 
 
The data will not be returned, and will be handled in compliance with VHA's Records Control 
Schedule (RCS 10-1). All de-identified data will be managed in accordance with the VHA 
Handbook 1605.1 APPENDIX B.  
 
Records destruction information:  "Any and all paper AND electronic documentation 
containing confidential, personally identifiable information, protected health information, and 
any other sensitive information will be disposed/destroyed according to current VA regulations 
at the time of disposal/destruction of documentation."   
 
Records retention information:  "The required records, including the investigator's research 
records, must be retained until disposition instructions are approved by the National Archives 
and Records Administration and are published in VHA's Records Control Schedule (RCS 10-1)." 
 
Reporting: Any incidents involving theft or loss of data or storage media, unauthorized access 
of sensitive data or storage devices or non-compliance with security controls will be immediately 
reported to the IRB chair, Privacy Officer and Information Security Officer. 
 
Data Analysis Software: Data will be analyzed using the software programs SPSS and MPLUS 
that are already owned by the VA either using local copies of the software or through VA 
Informatics and Computing Infrastructure (VINCI). 
 
Data use: Only IRB approved personnel will have access to the data collected in this study. 
Access to the study data will be terminated when personnel are no longer part of the research 

25 
 
team. De-identified copies of the study datasets will be sent to the parent site. The datasets will 
be checked by the Privacy Officer before they are sent to the parent site to verify  removal of all 
18 individually-identifiable information. 
 
VINCI: VINCI is a major informatics initiative of the Department of Veterans Affairs (VA) that 
provides a secure, central analytic platform for performing research and supporting clinical 
operations activities. It is a partnership between the VA Office of Information Technology 
(OI&T) and the Veterans Health Administration Office of Research and Development (VHA 
ORD). VINCI includes a cluster of servers for securely hosting suites of databases integrated 
from select national VA data sources. VINCI servers for data, applications and virtual sessions 
are physically located at the VA Austin Information Technology Center (AITC), located in 
Austin, Texas. This secure enclave with 105 high-performance servers and 1.5 petabytes of high-
speed data storage has multiple layers of security and disaster recovery to prevent data loss. 
 
To ensure the protection of Veteran data, VINCI maintains compliance with the guidelines set 
forth by Veterans Health Administration (VHA) Handbook 1200.12, Use of Data and Data 
Repositories in VHA Research, and all other applicable VA and VHA policies and regulations. 
In addition, VINCI has undergone all security certification activities in support of obtaining an 
Authorization to Operate (ATO). Access to VINCI resources are approved in accordance with 
the requirements of National Data Systems (NDS), VHA Handbook 1200.12, Use of Data and 
Data Repositories in VHA Research, and all other applicable VA and VHA policies and 
regulations. All data transferred from VINCI is subject to audit for compliance. 
 
VA-credentialed research or operations staff are granted access to study-specific data along with 
tools for analysis and reporting in the secure, virtual working environment through a certified 
VHA network computer within the VA.  If not working within a VA or VHA hosted office 
environment containing VA network access, researchers may apply for and then access VINCI 
through an approved Virtual Private Network (VPN) and Remote Desktop application. The 
remote computing environment enables data analysis to be performed directly on VINCI servers, 
offering a number of advantages: uniform security standards for access; a common point of entry 
for all investigators who use the data; tools for analysis and reporting; tighter and more 
consistent control of data quality; and the ability to standardize and update terminology and 
format as technology and methodology improve.  
 
Only study team personnel explicitly authorized by data stewards will have access to project 
data. The study principal investigator has the responsibility for security of study. VINCI data 
managers and VA OI&T personnel not under the purview of the study principal investigator 
control the servers, network, processors, firewall and software in the VINCI environment, 
including access rights granted to study personnel. 
 
When study personnel are no longer part of the research team, the study principal investigator 
will amend the data access request to terminate that person’s access to all study data and notify 
the VA Information Security Officer of such action. No sensitive patient data may be shared with 
anyone who does not have a VA appointment. All study team personnel with access to sensitive 
patient data must stay current on required VA information security and privacy policy trainings. 
 

26 
 
Study data stored on VINCI servers is located at the Austin Information Technology Center, 
1615 Woodward St., Austin, TX 78772-0001. The specific server where the data are stored 
within the VINCI environment will be chosen by VINCI personnel. The server name and 
location within the Austin Information Technology Center may be changed at any time at the 
discretion of VINCI personnel. 
 
 
 
 
Section 7. Data Safety and Monitoring 
 
Safety monitoring plan  
Frequency of DSM: In this study, we will use the FDA definition of serious adverse 
events (SAEs). RAs will report SAEs to the PI immediately. Data and safety of patients will be 
monitored by PI Creech . At a weekly meeting attended by PI Creech , study staff, participants’ 
safety, participants’ clinical status and adverse experiences will be reviewed. Entrance criteria of 
all participants will also be reviewed at these meetings. The PI will ensure that information on 
participants’ adverse effects are systematically collected and evaluated.  
Dr. Creech will immediately report any serious adverse events that are observed to the 
DSMB, medical monitor, Central Texas VAHCS IRB, and to the U.S. Army Medical Research 
and Materiel Command's (USAMRMC) Human Research Protection Office (HRPO). The initial 
SAE report will be followed by submission of a completed SAE report to the local IRB and 
HRPO. Outcomes of SAEs will be periodically reported to HRPO. A summary of the SAEs that 
occurred during the previous year will be included in the Quarterly Technical Progress Report 
that is submitted to HRPO.  
A Data and Safety Monitoring Board (DSMB) will be assembled to evaluate the data and 
safety to women veterans enrolled in the study. The DSMB will consist of 4 senior doctoral-
level/MD board members who have experience in clinical trials and/or alcohol/IPV/PTSD 
intervention research and/or research with women veterans as well as the ethical issues involved 
with a randomized controlled study, as indicated by peer-reviewed journal articles in these areas. 
We do not anticipate any difficulty in recruiting these qualified, independent board members as 
there is a pool of such researchers at the Providence, RI site and at the Central Texas site who 
have the relevant experience.  
The DSMB will convene twice in Year 1, and then once during Year 2 for a meeting. 
Initially, the Board will convene with the PI Creech and PI Zlotnick to review the study protocol 
and review the guidelines for data and safety monitoring. This will include establishing standard 
procedures for daily (whenever there has been contact with a participant) and weekly monitoring 
by the local internal reviewers (PI and study personnel). At this meeting and at each subsequent 
meeting, the DSMB will evaluate recruitment, the progress of the trial, subject retention, data 
quality and confidentiality. In addition, they will review participants' clinical status, rates of 
adverse events and whether or not there have been any changes in risk to participating subjects. 
This review will ensure that subject risk does not outweigh study benefits. In the DSMB’s review 
of adverse events, if non-serious adverse events are occurring at a significantly higher rate in one 
condition than the other, then the DSMB will make appropriate recommendations for changes in 
the protocol, if needed. If Serious Adverse Events (SAEs) occur at a significantly higher rate in 
one condition than the other, then the DSMB might consider terminating the trial, if changes to 

27 
 
the protocol are unlikely to address the high occurrence of the SAEs. We do not anticipate that 
this will occur, because we have taken several steps to avoid or protect against the occurrence of 
SAEs as outlined in the Human Subject Recruitment and Safety Procedures section. A report 
generated from each of these meetings will be retained at the study site and will be forwarded to 
the local IRBs, USAMRAA, and will be included in the Quarterly Technical Progress Report.  
The DSMB will be available to convene outside of the appointed meeting schedule, if 
necessary, due to concerns regarding a particular subject, or due to any troublesome 
developments in subjects' experiences during the study. The DSMB will make appropriate 
recommendations for changes in the study protocol, if needed. The safety of participants will be 
monitored during each contact with study participants. Both anticipated and unanticipated 
adverse events and problems will be formally monitored and recorded. Unanticipated serious 
adverse events or problems will be reported to the DSMB, medical monitor, within 24 hours. 
A Medical Monitor will be appointed to this study. This individual will not otherwise be 
associated with this protocol, and will be able to provide appropriate medical care to research 
volunteers for conditions that may arise during the conduct of the study. Adverse experiences 
that are both serious and unexpected will be immediately reported by telephone to the U.S. Army 
Medical Research and Materiel Command's (USAMRMC) Human Research Protection Office 
(HRPO). A written report will follow the initial telephone call within 3 working days to the U.S. 
Army Medical Research and Materiel Command and to the appropriate local Institutional 
Review Boards (IRBs). The Medical Monitor is required to review all serious and unexpected 
adverse events (per ICH definitions) associated with the protocol, and provide an unbiased 
written report of the event within 10 calendar days of the initial report to the addresses above.  
All study personnel and investigators will annually complete the required VA training 
and courses in human participant research protections. PI Creech will maintain documentation of 
human research training requirement for all study personnel and submit the required information 
and training certificates to the VA Research Office with every new protocol submission. All 
investigators at both sites are certified in human subjects education by their respective 
institutions. Monitoring of safety in the proposed study will be the responsibility of all personnel 
on the project, with primary responsibility and supervision by Dr. Creech. The Institutional 
Review Board at the Central Texas VAHCS will approve the protocol and the Statement of 
Informed Consent for the study and will provide oversight of data and safety issues. Separate 
reviews of the protocol and consent form are made by the safety officer at the VA Medical 
Center. The study protocol will receive IRB approval prior to soliciting or requesting consent 
from any participants. Moreover, the study will be reviewed on an annual basis (continuing 
review) by the IRB committee with regard to recruitment and retention and annual reports will 
be made by the PI to the IRB chair of the Central Texas VAHCS regarding the progress of the 
proposed project, including any issues pertinent to recruitment, retention, confidentiality, and 
safety of human subjects. Any incidents that involve a breach of this plan or serious 
accident/injury will be reported to the IRB chair. As discussed, potential risks, albeit minimally 
likely, include distress or discomfort with questions regarding trauma history.  
 
Adverse Event Reporting 
In the case of an adverse Effect (AE) or a Serious Adverse Effect (SAE), a written report 
of the AE or SAE will be prepared for the Chair of the IRB at the Central TX VAHCS. Any such 
AEs or SAEs will be presented to the full IRB committees. SAEs will be reported within 24 
hours. Examples of serious adverse effects include death, life- threatening adverse events, 

28 
 
suicide attempts, and inpatient hospitalization. The report of such AEs or SAEs will include 
whether they were expected or unexpected, a rating of severity of the event, a brief narrative 
summary of the event, a determination of whether a causal relationship existed between the study 
procedures and the event, whether the informed consent should be changed as a result of the 
event, and whether all enrolled participants should be notified of the event. The annual progress 
reports to the IRB require summary information regarding all AEs and SAEs occurring during 
that year. A medical monitor who is independent of the research will be named. The medical 
monitor will be called upon to review all AEs and SAEs, and to provide input regarding the 
possible connection to the study protocol. 
 
Risks / Benefits Assessment  
 
Risks/Benefits Assessment:  
Foreseeable risks: There are four major areas of low to moderate risk associated with 
participation in the proposed study: 1) It is possible that some women may feel coerced into 
participating in the research. 2) There is risk to confidentiality and loss of privacy. We will be 
collecting considerable information about the participants that may create some distress and 
could cause social and psychological risk if released inappropriately. 3) Research participants 
may decompensate when completing the assessments included in the research proposal. 4) 
Participation may place women at risk for further victimization if an abusive partner finds out 
about their participation in the research. The procedures we will use to minimize these risks are 
described below.  
Data and safety monitoring will take place to assure the safety of subjects. All 
participants will be reminded that their participation is voluntary and that they can withdraw at 
any time without penalty. Additionally, the risks described above will be minimized by the 
following procedures:  
1.   We will minimize the risk of potential coercion by following standard procedures for 
obtaining informed consent. We will begin this process during the intake for the screening phase 
and the trial phase, where we will clarify the nature of the study and possible alternatives 
upfront. Prior to enrolling women in the research, we will fully explain the study procedures, 
risks, benefits, and alternatives to women. Participants will be reminded that study participation 
is voluntary and that refusing to participate or withdrawing from the study at any time will not 
impact in any way their relationship to the Central Texas VA or any other VAMC, or existing 
services they receive within the community Veterans will have the opportunity to discuss any 
uncomfortable feelings with the assessment or intervention with the research assistant who will 
be available during both the assessment and intervention. The Veteran will also be informed that 
the veteran’s well-being and safety takes priority over research considerations. Furthermore the 
veteran will be informed that should they experience any problems, they should report them to 
the research assistant or to the principal investigator of this study. All reimbursements for 
participating will be commensurate with participants’ time required for participating in the 
research. 
2.   We will minimize potential risks due to loss of confidentiality of research data by 
having all information collected and handled by research staff trained to deal appropriately with 
sensitive clinical issues. All participants will be informed about the limits of confidentiality 
concerning suicidal intent, homicidal intent, suspected child abuse, and suspected elder abuse. 
All information will be treated as confidential material and will be available only to research 

29 
 
staff. All information will be kept in locked file cabinets in locked offices. Computer data files 
will be available only to authorized personnel and no names or obvious identifying information 
will be stored in data files. Information, including assessments, collected in this study will not be 
entered into participants’ medical records at the PVAMC. No participant will be identified in any 
report of the project. Veterans will be informed that federal and non-federal monitoring agencies 
such as the Department of Veterans Affairs may access the veteran’s research records related to 
this study to monitor the security of the trial. Furthermore, veterans will be informed that 
complete confidentiality cannot be promised to subjects, particularly to subjects who are military 
personnel, because information bearing on their health may be required to be reported to 
appropriate medical or command authorities. Written consent will be obtained to contact other 
persons for the purpose of locating the participant for follow-up and participants can refuse or 
revoke such consents. All study personnel who handle data will be trained in confidentiality 
policies and procedures.  
Participants in the open trial or randomized control study phase will update their contact 
information at each follow-up interview to ensure that this information remains appropriate. To 
further protect participants, a Confidentiality Certificate will be sought after the grant has been 
funded. Potential subjects will be informed that a Certificate of Confidentiality has been obtained 
for this project and that this certificate will protect the investigators from being forced to release 
any research data in which participants can be identified, even under court order or subpoena, 
although this protection is not absolute. Potential subjects will be informed of the situations in 
which they may not be protected under the Certificate of Confidentiality. No information about 
participants will be released without their permission or where required by law.  
Audio recording of informant interviews and exit interviews is also needed to produce 
structured transcripts and identify themes. This is accomplished through the use of digital audio 
recorders, which can hold hundreds of hours of voice recordings. These digital recordings will be 
uploaded to the CTVHCS secure research server (W drive). Participants will be asked to give 
informed written consent to audio recording at the time of study entry. To assure the 
confidentiality and protection of participants with respect to audio taping, the following steps 
will be taken: a) each recording will be labeled with the participant’s study identification 
number, and the recording date; b) all recordings will be stored in a restricted folder on the 
secure research server CTX W drive   c) access to the audio recordings will be limited to the 
specially trained staff who will code the recordings and create structured transcripts; d) once the 
recordings are transcribed they will be stripped of all identifiers for the purposes of analyses; at 
the end of the study, the recorder will be given to OI&T for sanitization. 
All data and medical information obtained about the veteran, as an individual, will be 
considered privileged and held in confidence; the veteran will not be identified in any 
presentation of the results. Assessments and intervention sessions will occur at the CTVHCS. 
Veterans will be informed that their VA medical records will note their enrollment in a research 
study with a copy of their consent form attached. In addition, their attendance at each 
intervention session will be noted in their medical records. This will include, if applicable, any 
safety issues (e.g., suicidal or homicidal statements they made) and how these were addressed in 
treatment. The veteran will be informed that none of the other data from this study will be 
included in their Medical records. All study data stripped of identifying information, will be 
locked in a file cabinet. Records will be maintained per Veterans Affairs Record Control 
Schedule 10-1. All of the study data will be coded without the use of the veteran’s name and 
social security number and will be done in accordance with the law. Research information about 

30 
 
the veteran will remain in locked private research files and will be available only to staff 
connected with this study or individuals involved in human subjects protection. Any reports or 
publications of this study will not include information that could be used to identify the veteran. 
All forms with participant information will be marked with a code number and not with 
the participants’ name. The PIs will keep the link between the participant code number and name 
in a separate restricted folder on the CTVHCS secure server (W drive). . Information that might 
potentially allow an individual participant to be identified will not be allowed in any publications 
or reports sent to individuals outside the study.  
In accordance with VA policy, incidents such as theft or loss of data or storage media, 
unauthorized access of sensitive data or storage devices or non-compliance with security controls 
will be reported immediately to the ISO and PO.  
3.   We will minimize the risk of distress. Participants from our target population face the 
risk of increased distress during assessment procedures, during the control condition, or during 
the experimental condition. The potential that veterans might develop uncomfortable feelings 
during assessments and the intervention will be discussed during the consent process. Possible 
distress due to sensitive items will be noted clearly in the informed consent information sheet 
(for screening) and in the written informed consent form (for participants). Participants will be 
informed that they can refuse to answer any question or stop the assessment or intervention at 
any time. They will be informed that they can chose to resume the assessment or intervention or 
refuse to participate further. Veterans will have the opportunity to discuss any uncomfortable 
feelings with the assessment or intervention with the research assistant who will be available 
during both the computer-based assessment and intervention. Moreover, clinical backup will be 
provided during all assessments and during the intervention phase of the study by a licensed 
clinician to help facilitate any stabilization and referral process for participants who 
decompensate during study procedures. The need for additional services will also be monitored 
during all follow-up assessments. The veteran will also be informed that the veteran’s well-being 
and safety takes priority over research considerations. Furthermore the veteran will be informed 
that should she experience any problems, she should report them to the research assistant or to 
the principal investigator of this study.  
To further address possible distress due to sensitive items, participants will be asked by 
the computer program if anything the computer has asked or done is making them feel upset 
right now. The computer program will notify the research team at completion of the screening, 
intervention session, or assessment, if any participant answers yes to this question, in addition to 
notifying the research assistant (RA) if the participant endorsed any items indicative of possible 
need/desire for further assistance. (Note that the computer program will not provide details 
regarding any answers, only that there is a need to follow-up with the participant verbally to 
evaluate the need for assistance). At a minimum, all participants indicating some distress will be 
given a list of referral and resource options.  
Any participant verbalizing or showing signs of distress will be asked to remain in the 
assessment or intervention setting until their distress is at a manageable and comfortable level. 
No participant judged to be in danger of harm to self or others will be allowed to leave the study 
setting unaccompanied. All study personnel who interact with study participants (including 
phone contacts) will have been professionally trained to respond to negative emotions if these 
should occur and to access emergency services if necessary.  All participants will be reminded of 
appropriate safety procedures including providing them with emergency contact numbers such as 
911 and the number for the Veterans Crisis Line. All research personnel will be trained in the 

31 
 
protocol for homicidal or suicidal risk and research procedures for these situations. A licensed 
clinician will be available at all times by phone Research staff will contact the licensed clinician 
if there are any safety concerns.  
The assessment instruments and program techniques are commonly used in research and 
clinical practice. We will minimize distress by presenting questions/program techniques in a 
supportive manner, assuring participants that they may refuse to answer questions that make 
them uncomfortable, and may terminate the assessment and/or intervention at any time. Any 
participant verbalizing or showing signs of distress will be asked to remain in the assessment or 
treatment setting until their distress is at a manageable and comfortable level. No participant 
judged to be in danger of hurting him/herself or others will be allowed to leave the study setting 
unaccompanied. All study personnel who interact with study participants will have been 
professionally trained to respond to negative emotions if these should occur and to access 
emergency services if necessary. 
Moreover, clinical backup will be provided during all assessments and during the 
intervention phase of the study by a licensed clinician to help facilitate the stabilization and 
referral process for participants who decompensate during assessment procedures. Dr. Creech is 
a licensed clinical psychologist and she will be available by phone or in person during study 
assessments. Since the study will take place in women’s primary care during normal operating 
hours, access to emergency resources will be readily accessible  The need for additional services 
will also be monitored during all follow-up assessments. Participants will be formally assessed at 
intake and then at the 2- and 4-month follow-up period. If a participant indicates distress during 
any phase of the study, the clinical back up will be contacted to facilitate the stabilization and 
referral process. Women veterans who report significant suicide or homicidal risk will be 
referred for appropriate additional care, but will remain in the research protocol. During any 
phase of the study, women who report significant homicide or suicide risk will be immediately 
referred for evaluation for psychiatric admission at the closest emergency department. All 
participants will be eligible for emergency services through the CTVHCS.  
Referral to treatment and counseling during the study. After screening and prior to 
randomization, all study participants will receive a list of appropriate referrals (e.g., 24-hour 
hotlines for sexual trauma and intimate partner violence (IPV), as well as mental health and 
substance abuse treatment). Additionally, no referral, or counseling will be withheld in any way 
at any time during the study. At follow-up assessments, any participant who screens positive for 
heavy drinking or PTSD will be referred for appropriate clinical care, for example consults will 
be placed for further care if the Veterans desires. In addition to referrals within the VA, we have 
a list of free or low-cost substance use and mental health treatment clinics in Central Texas.. 
Likewise, at follow-up assessments, any participant who reports current ST and/or IPV will be 
provided with information on ST/IPV and a list of local IPV/ST resources and an offer for 
contact with the local VA Domestic Violence coordinator or Women Veterans Program 
Manager.  
4.   We will minimize the risk of study-related partner violence. Women who have 
abusive partners may be at increased risk for abuse if he or she were to find out about the 
woman’s participation in the research project. The measures suggested by Sullivan and Cain 
(2004)[22] will be taken to maximize participant safety throughout the research.. Outgoing 
phone calls will go through the VA landline phone system which is identified at the receiving 
end as a general VA number not specific to any VA Hospital department. All incoming phone 
calls will go through a study specific cell phone. This line is answered, “The Women’s 
Program,” and partner violence is never mentioned. Details of the research are not provided to 
anyone other than the actual participant. During each contact, participants will first be asked if it 

32 
 
is a safe time to speak. Safe contact for follow-up assessments will be negotiated at each stage of 
the research. Both written and verbal contacts will be vague. Follow-up interviews will be 
scheduled at VA primary care or in the research space at the Center of Excellence. Safety plans 
will be negotiated up front (e.g., code words, cover story for reason for interview) if ever the 
abuser were to interrupt a phone call or assessment. Any handouts with important information 
(e.g., hotline numbers) will be available in wallet size copies without any reference to the study 
or name of organization. Participants’ safe contact information will be updated monthly to 
determine if the contact information they previously provided is still accurate and safe. 
Participants will be given contact information for the research team and/or interventionist and 
asked to let us know if the contact information they provided is no longer safe. A licensed 
clinician will be available for consultation on difficult cases at all times by phone. If a woman 
discloses that she is in an abusive relationship, she will be provided with the battered women’s 
crisis line for emergencies, referrals to battered women’s shelters, and told how to obtain a 
restraining order and she will be connected with the VA women’s health coordinator and 
domestic violence coordinator for additional assistance. All participants will be reminded that if 
they are currently in an abusive relationship, their partner could find the infromed consent form 
from the study and this could place them in danger because it makes mentions of partner 
violence. They may wish to store it/dispose of the form in a secure location. 
 
If the partner of the participant is also abusing her child[ren], then the interventionist, 
supervisor, or research staff person involved will let the woman know that she as the mother is 
responsible for protecting her child[ren] and if her partner hurts them and she fails to call child 
welfare or the police, she could be charged with neglect and her children could be taken away. 
The supervisor/research staff will encourage the woman to call child welfare herself as child 
welfare is more likely to view the woman favorably under these circumstances. The research 
personnel involved will provide the woman with the relevant phone number/s. The research 
personnel involved will let the woman know that she/he will be calling child welfare her/himself 
because it is the law. This same procedure will be followed for any other case of suspected child 
abuse. 
 
Potential Benefits of the Proposed Research to the Subjects and Others  
The main benefit for participants is their contribution to the scientific understanding of an 
intervention for women veterans with ST that targets IPV, heavy drinking, and PTSD. The 
information gained through this research will help us to develop and empirically evaluate the 
efficacy of an intervention for this population.  
The potential risks associated with participation in this study appear to be mild to 
moderate. Although there is a risk for distress, the procedures proposed for monitoring distress 
should ensure that participants who require a higher level of care receive it. The potential 
benefits of study participation who receive the SHE intervention are great, and include reduction 
in IPV, heavy drinking, and posttraumatic stress disorder (PTSD) symptoms. Half of the 
participants in this study will not receive any form of intervention, and thus are unlikely to 
receive any direct health benefit; however, women in both conditions as well as all women who 
participate in the screening phase of the study will receive a list of referrals and consults to VA 
mental healthcare will be placed as requested/needed. Moreover, participants are helping other 
women veterans seeking primary care treatment through providing information that could 
potentially improve heavy drinking, PTSD symptoms, and IPV. There is no cost to participants 
to participate in this study. Based on the foregoing discussion, it is our view that the potential 
benefits of participating in this study appear to outweigh the minimal risks of participating. 

33 
 
Potential risks include distress associated with discussing traumatic or other disturbing events or 
emotions, and breach of confidentiality.  
 
Importance of Knowledge to be Gained  
The ultimate objective of this research is to provide a low-cost and effective intervention 
that may be scaled up with ease, fidelity and speed in VA primary care settings nationwide for 
women veterans with any lifetime ST. Lifetime ST is highly prevalent among women veterans 
with two thirds (62%) reporting a sexual assault during their lifetime, and up to 45% reporting 
military sexual trauma. ST is strongly associated with posttraumatic stress disorder (PTSD), 
intimate partner violence (IPV), and alcohol misuse. Numerous barriers prevent consistent 
delivery of interventions appropriate for women veterans with any lifetime ST; a high-risk 
population. The SHE program will address the needs of women veterans with lifetime ST within 
a primary care setting. Primary care settings present an ideal opportunity to provide behavioral 
interventions for our population because they are frequent points of health care contact for VA 
women. Findings from this proposal will lay the groundwork for a larger clinical trial of the SHE 
program in multiple VA primary care settings. This treatment development study is especially 
timely, since number of women veterans enrolled in the VA system is estimated to grow by 33% 
in the next three years. Furthermore, since screening for MST is mandated within VAs, a 
computer delivered intervention has the potential to be easily integrated into the standard of care 
for women veterans who screen positive for any ST history and could potentially increase the 
identification of high-risk women veterans. In addition, given the VA will institute mandatory 
screening for domestic violence in all women veterans within the next two years, SHE represents 
an ideal intervention to be paired with this screening. 
The computer-based intervention, SHE, is easily transported and inexpensive, and if 
successful, SHE could be applied rapidly and widely in different settings and with different 
populations with ST, including male veterans as well as service members. Finally, there is strong 
potential for significant impact in terms of quality of life for women veterans and service 
members, and for their families, and in reducing costs of disability and health care, and more 
broadly societal costs. 
 
 
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