Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE): Tailoring and Evaluating a Patient-Centered Counseling Intervention for Women Veterans
Phase: NA
Conditions: Intimate Partner Violence, Self-efficacy
Sponsor: VA Office of Research and Development

May 12th, 2020 
 
1 
 
 
Research Protocol and embedded Statistical Analysis Plan for RISE RANDOMIZED CLINICAL TRIAL  
PI: Dr. Katherine Iverson 
VA Boston Healthcare System 
 
Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE) 
 
NCT03261700 
 
Funded by the VA Office of Research and Development, Health Services Research and Development 
(HSR&D) Services, IIR 16-062.  
 
Research Protocol and Analysis Plan are from the approved research protocol from the VA Boston 
Healthcare System Institutional Review Board and focus on the background, significance, procedures, 
measures, etc. for the randomized clinical trial of RISE, as reported in ClinicalTrial.gov. Note that this 
RCT was completed as part of a larger study to develop, refine, and evaluate RISE (VA HSR&D IIR 16-
062: Iverson). 
 
The Statistical Analysis Plan is found on pages 17-18 of this protocol, under “Quantitative Analysis”. 
 
  
 
     
 
 
 
 
 
 
 
 
 
 
 
Research Protocol and embedded Statistical Analysis Plan for RISE RCT. 

May 12th, 2020 
 
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Introduction: This HSR&D-funded study consists of three phases toward the overall goal of refining and 
evaluating a patient-centered brief counseling intervention for female VA patients who experience intimate 
partner violence (IPV). The draft intervention of Recovering from IPV through Strengths and Empowerment 
(RISE) was developed by Drs. Iverson, Gregor and Gerber during Dr. Iverson’s HSR&D Career Development 
Award. Phase 1 of the research consists of gathering stakeholder feedback from VA patients and providers to 
initially tailor and refine the RISE intervention manual and delivery characteristics. Phase 2 consists of a small, 
formative open trial to pilot-test the RISE intervention and make additional modifications to the RISE 
intervention manual and implementation characteristics prior to preparing the intervention for effectiveness 
testing.  Phase 3 consists of a randomized clinical trial (RCT) at the VA Boston Healthcare System to examine 
the effects of RISE on psychosocial outcomes relative to an information/referral comparison condition. We 
have received IRB approval for all phases of this study. The study takes place at the VA Boston Healthcare 
System. This Phase 3 RCT is the focus of this protocol and analytic plan. 
(1) Rationale 
 
a. Statement of the problem: Intimate partner violence (IPV) is a major health concern for women Veterans. 
IPV is associated with numerous physical and mental health conditions. VHA is implementing IPV 
screening programs to identify female patients who experience past-year IPV. Despite strong evidence that 
screening increases detection of IPV, less is established about how to intervene following IPV disclosure in 
health care settings, in order to improve health outcomes. Existing healthcare-based interventions result in 
minimal effects on health and well-being, likely because they are too brief and generic. In response, the PI 
has developed Recovering from IPV through Strengths and Empowerment (RISE), based on the IPV-
related health care needs and preferences of women Veterans. RISE is designed to be delivered in primary 
care and is an individualized, variable-length, modular-based intervention that addresses 1) safety planning; 
2) education on the health effects of IPV; 3) increasing coping skills and self-care; 4) enhancing social 
support; 5) making difficult decisions; and 6) connecting with resources. This study is aimed at refining 
and evaluating RISE for use with female VA patients who have experienced past-year IPV.  
Phase 3 consists of a Hybrid 1 randomized clinical trial (RCT; n=68) to examine the effects of RISE on 
women Veterans’ psychosocial outcomes (e.g., empowerment, self-efficacy, health, and service use) 
relative to an information/referral comparison condition. A secondary aim is to examine the feasibility 
and acceptability of RISE in the context of the RCT. 
Specific Aims 
Phase 3: 
Aim 3. Examine the effects of RISE on WVs’ individual psychosocial outcomes with an effective-
implementation Hybrid 1 RCT 50 that compares RISE to an information/referral condition with up to 68 female 
patients at VA Boston. We will collect pre-treatment, post-treatment, and 1-month follow-up patient data to 
examine the effects of RISE on key psychosocial outcomes.  
(2) Background and Significance 

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(a) Background: 
Societal Impact of Intimate Partner Violence: 
 
Intimate partner violence (IPV) against women is a significant public health issue. IPV victimization 
includes psychological, physical, or sexual aggression perpetrated by a past or current intimate partner. Women 
are much more likely than men to experience severe violence and health-related impacts.1 Nearly 7 million 
women are physically assaulted, raped, or stalked by an intimate partner in the United States (U.S.) annually.1 
These assaults are a leading cause of injury to women. At least 3 women are murdered by intimate partners 
every day in the U.S.2 IPV is also associated with poor physical and mental health.3-5 Physical health problems 
range from injuries or conditions directly caused by assaults, to other chronic musculoskeletal, cardiovascular, 
gastrointestinal, and reproductive health conditions.4,6,7 Mental health problems often include posttraumatic 
stress disorder (PTSD), depression, anxiety, substance abuse, and suicidality.4-7 IPV also increases risk for 
financial difficulties, unemployment, and homelessness.8 
Veterans Health Administration Response to IPV: 
 
IPV is a critical issue for the Veterans Health Administration (VHA). Women are the fastest growing 
group of VHA patients, with their population recently increasing by 80%.9 Women Veterans (WV’s) are at 
higher risk for IPV than their non-Veteran peers, with Co-I Dr. Dichter finding that 1 in 3 WVs report lifetime 
IPV, compared to 1 in 4 women in the general U.S. population.10 Research by our team finds that up to 30% of 
WVs experience past-year IPV.6,11,12 As a result, WVs are considered an important population for IPV 
screening and counseling interventions.13-16 In response, VHA Women’s Health Services (WHS) and the IPV 
Assistance Program of Care Management and Social Work Services (CMSWS) are implementing IPV 
screening programs for women and are seeking an effective intervention to implement into care (Veterans 
Health Administration Domestic Violence Task Force; U.S. Department of Veterans Affairs). 
 
Limitations in Current Healthcare-Based IPV Interventions: 
 
Tests in healthcare settings of brief counseling interventions for IPV have resulted in minimal effects on 
patients’ health and safety.17-19 Existing interventions typically consist of one 10- to 35-minute session and are 
focused on referral to community-based resources.20,21 A systematic review conducted by Co-I Dr. Bair-Merritt 
found that these types of interventions result in very modest effects on patient outcomes, with increased service 
usage being the most common benefit.21 A recent review of IPV screening trials highlighted insufficient 
intensity of post-disclosure counseling interventions, concluding that existing interventions are too brief, 
unstructured, and generic.18 Such minimal intervention effects of the current standard of care have led leaders in 
the field to call for the development and testing of new and more comprehensive IPV interventions,18,22,23 
especially for delivery in primary care.21,24 The Recovering from IPV through Strengths and Empowerment 
(RISE) intervention fills this need. 
 
Opportunity for IPV intervention during primary care visits: 
 
Women who experience IPV present frequently for health services, with some evidence showing a 4-
fold increase in utilization attributable to IPV, especially in primary care.25,26 IPV screening in primary care is 
safe and effective for identifying abused women,17 yet screening without offering structured intervention to 
those who disclose IPV offers limited benefit.27,28 VHA identifies primary care settings as key contexts for 

May 12th, 2020 
 
4 
 
implementing IPV screening programs.29 Our research suggests VA primary care settings are ideal for 
implementing and evaluating IPV interventions, as the Patient Aligned Care Teams (PACT) structure facilitates 
uptake of IPV screening and counseling.30 VHA does not, however, have protocols for what post-disclosure 
counseling should entail. This proposal capitalizes on the roll-out of IPV screening programs, aiming to 
enhance their effectiveness. 
 
RISE Background and Theoretical Basis: 
 
RISE is a promising and innovative intervention for IPV. The PI, who has 14 years of clinical 
specialization in IPV, developed RISE based on her HSR&D CDA findings in conjunction with two national 
experts in women’s primary care and behavioral health, Drs. Gerber and Gregor (Co-Is). RISE was developed 
using rigorous methods, including extensive literature review, as well as focus groups and surveys with WVs 
who experienced IPV11,31 and qualitative interviews with VA providers.30,32 It was subsequently piloted 
successfully in clinical practice. RISE is a primary care-based trauma-informed psychosocial intervention for 
female patients who experience IPV. RISE is designed to overcome the limitations of existing brief 
interventions for IPV. It is variable-length and consists of an initial session of up to 60 minutes, with up to 5 
additional 60-minute sessions (i.e., up to 6 sessions total). This format is consistent with brief counseling 
standards established for Primary Care Mental Health Integration (PC-MHI) (VHA Handbook 1160.01). Many 
VA primary care clinics have implemented PC-MHI, which may be ideal for implementing RISE (personal 
communication, Dr. Sally Haskell, WHS Deputy Chief Consultant, June 10, 2015). VHA also recommends that 
all VAMCs designate domestic violence coordinators (DVCs) who provide education to clinicians, connect 
patients with IPV-related resources, and provide some clinical care. A strength of RISE is that it can be 
delivered by various providers within primary care (e.g., PC-MHI providers, nurses, social workers) or by 
providers closely aligned with primary care. This flexibility accommodates the realities of real world practice, 
including the limited clinical role of many DVCs. 
 RISE has a strong theoretical 
basis33,34 that is trauma-
informed and highly aligned 
with VHA’s emphasis on 
flexible, empowerment-driven, 
patient-centered care 
individually tailored to 
women’s needs and 
preferences. See Figure 1 for 
conceptual model underlying 
RISE. Studies have found 
increased empowerment, self-
efficacy, and patient activation to alleviate mental health symptoms and lead to improved service utilization and 
quality of life among women who have experienced IPV.35-38 RISE is expected to improve patients’ physical 
and mental health, safety, service use, and quality of life through enhancing empowerment, self-efficacy and 
patient activation 
 
RISE is a modular-based intervention that incorporates several aspect of Motivational Interviewing 
(MI). Compared to highly structured protocols, modular interventions have been found to be more flexible and 
Treatment Content and Characteristics 
 
Immediate Goals 
 
Patient Outcomes 
 
Safety planning 
Education on health effects of IPV 
Improving coping and self-care 
Enhancing social support 
Making difficult decisions 
Connecting with resources 
 
Increased: 
Empowerment 
Self-efficacy 
Patient 
activation 
 
 
 
Increased: 
• Quality of life 
• Mental health 
• Physical health 
• Safety behaviors 
• Service use 
Reduced 
• IPV 
Motivational 
Collaborative 
Non-confrontational 
Figure 1. Conceptual Model of Impact of RISE on Psychosocial Outcomes 

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better able to address individual patients’ needs, preferences, and circumstances,39 as well as more effective and 
acceptable to providers.40 Through use of non-confrontational and collaborative MI techniques,41 such as 
eliciting patient perspectives and reflective listening, the provider empowers women to choose from 6 modules 
(see Table 1) to focus on during the session based on her individual needs. MI is used to set goals and plan for 
behavior change, as desired and driven by the patient. MI is an efficacious approach for many psychosocial 
problems and for numerous behavioral changes42 and highly theoretically relevant for women who experience 
IPV. The draft RISE manual, which will be modified and refined based on findings from Aim 1a, is found 
in the Appendix.  
 
Delivery of RISE:  
RISE includes the essential components of prior brief counseling interventions for IPV21 but provides a 
more comprehensive and individualized approach to improving women’s health and safety. In the initial 
session, women are offered safety planning tips and a resource list. Women are then given a menu of options to 
select from based on their current needs and preferences. For example, a woman may choose to focus on safety 
planning in detail or she may select coping skills/self-care to better manage stress. The principles of 
empowerment and flexibility undergird the format. The patient can choose to focus on the same module in her 
next session or select a new module. This pattern is repeated for up to 6 sessions or when the woman no longer 
needs or desires further intervention, consistent with brief counseling standards (VHA Handbook 1160.01). In 
the latter case, it is a collaborative decision made between the patient and provider. An important feature of 
RISE is laying the groundwork for necessary referrals (e.g., to mental health) that women are offered during and 
upon completion of RISE. Given the current state of the pandemic, COVID-19, we are requesting to deliver 
RISE via teletherapy (phone) and videoconferencing using VA-approved platforms (e.g., VVC). More 
specifically, we are requesting that the PI (Dr. Iverson) the two RISE providers on the study, Drs. Danitz and 
Brennan, who are both licensed clinical psychologists, be able to conduct RISE sessions from their homes via 
telephone, with adherence to VVC requirements. In order to ensure participant safety when conducting 
teletherapy or videoconferencing, providers will confirm the participant’s address and  phone number at the 
beginning of the call and follow usual clinical guidance for managing any emergent SI or other risk issues, as 
we would in routine care.  We will ensure the participant is in a safe place where she can speak freely.  With 
participant permission in advance of the session, we will send RISE resources and handouts as well as our in-
session measures, which we will collect at the beginning of the session via teletherapy. While teleworking RISE 
providers have full access to CPRS, suicide coordinators, and have access to clinical resources, such that 
providers are able to address any emergent concerns that arise for participants. As such this delivery modality 
does not pose any increased risk to participants or study providers, and is in accordance with recommended 
precautions and procedures of social distancing during this unprecedented time.  
Table 1. RISE Modules (based on IPV intervention literature, theory, and stakeholder recommendations)  
Safety Planning 
Safety of self, children and pets in different situations (e.g., in an argument, leaving, stalking) 
Education on Health Effects of IPV 
Effects of IPV on physical, psychological, and social health, including effects on children 
Improving Coping and Self-Care 
Learning basic coping and self-care strategies (e.g., diaphragmatic breathing, pleasant events) 
Enhancing Social Support 
Skills for approaching friends or family to enhance emotional and practical support 
Making Difficult Decisions 
Thinking through options and choices when making difficult decisions (e.g., ending relationship) 
Connecting with Resources 
Resources available in VA and the community (e.g., mental health, housing, legal aid, shelter) 

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Replicating Effective Programs 
(REP) Framework Guides This 
Project: 
As shown in Figure 2, the 
proposed study is guided by an 
established implementation 
framework. Use of an 
implementation framework that is (a) theory-based, (b) highly specified, and (c) widely used in VHA can 
facilitate incorporation of RISE into routine VHA care. The REP framework,43,44 based on principles of Social 
Learning Theory and Diffusion of Innovation, is an ideal guide for the current work. REP emphasizes tailoring 
and refining interventions for healthcare practice through extensive stakeholder input and iterative cycles of 
pilot testing. Using the REP framework to guide this proposal enables us to address up front potential 
challenges to future implementation. We will ground our tailoring and evaluation of RISE in REP’s first and 
second phases: pre-conditions and pre-implementation. These two phases require a fine-grained understanding 
of patient and provider perspectives that impact implementation efforts, as well as VHA operations partners’ 
needs. We will therefore incorporate multilevel stakeholder engagement throughout the proposed study to 
inform RISE modifications.  
 
(b) Significance: 
Advancing Innovations in VHA Health Care: 
The VHA Blueprint for Excellence45 identifies promoting patient-centeredness and “advancing 
innovations in WV’s health care” as key transformational strategies. Newly released VHA breakthrough 
priorities include improving the Veteran experience and increasing access to care.46 This project advances these 
goals for IPV care. Up to 30% of WVs experience past-year IPV, which contributes to numerous physical and 
mental health conditions among WVs.6,10,11,15 Despite national VHA recommendations to screen female patients 
for IPV,47 there is a lack of empirically supported brief counseling intervention for those who disclose IPV. This 
project will fill this gap by evaluating an innovative, patient-centered brief counseling intervention for IPV that 
is tailored to WVs’ unique healthcare needs and preferences.45 RISE holds great promise for improving patient 
outcomes because it is evidence-informed, conceptually-driven, and embodies essential components of patient-
centered care. RISE is empowerment-based33,34 and flexible (i.e., modular and variable-length).48 Given the high 
prevalence of IPV among WVs and its significant health effects, RISE is expected to reduce morbidity among 
VHA patients. As such, our proposal is highly responsive to the HSR&D priority area of improving health care 
and health outcomes for WVs. 
 
Importance to VHA Operation Partners:  
Addressing the misalignment between VHA guidelines and actual practice is of high importance to our 
VHA operational partners in WHS, CMSWS, Women’s Mental Health Services (MHS) and PC-MHI/Primary 
Care. This project will yield a high return on investment by producing a flexible patient-centered intervention 
that can be rigorously applied and tested in VHA, thereby addressing a critical gap in current IPV care. This 
research may also assist our operational partners in broadening their focus beyond IPV screening and 
 
Pre-Conditions  
(Aim 1) 
• Create new 
intervention 
• Ensure intervention 
fits local settings  
• Identify barriers  
• Refine intervention  
 
 
Pre-Implementation 
(Aims 2 and 3) 
• Evaluate intervention 
through iterative pilot 
testing 
• Additional input from 
stakeholders 
• Further intervention 
package refinement  
• Train providers 
• Technical  
assistance 
• Formative 
evaluation 
• Feedback and 
refinement  
Implementation 
Maintenance & 
Evolution 
• Organizational 
changes 
• National 
dissemination 
• Re-customize 
delivery  
Current Proposal 
Subsequent IIRs 
Figure 2. REP Implementation Framework as It Guides Current Proposal  

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interventions for women. VHA currently recommends a case-finding approach for men (i.e., asking about IPV 
upon clinical suspicion).47 Although the need for IPV interventions is most urgent for WVs because of the clear 
disparities in IPV and linked health outcomes,1,15 RISE could eventually serve as a viable intervention for men 
who experience IPV. 
 
Innovative Design: 
The well-documented gap between the identification of clinical innovations and their implementation 
into routine care40,49 exists partly due to a research methodology in which efficacy is first established, followed 
by effectiveness research, with little early systematic effort to understand the potential for implementation. An 
innovative and efficient solution is to collect implementation data in the context of effectiveness research (i.e., 
our Hybrid 1 RCT design) to inform refinements that will facilitate the intervention’s ultimate integration into 
routine care.49,50 If RISE proves effective, this program of research will increase the speed in which VHA is 
able to implement RISE nationally and can provide a methodological template for other studies. 
 
(c) Relevance to Veterans: 
This research will lead to enhancement in care for female Veterans and likely improve their experience with 
IPV-related care in VA.  IPV alienates female Veterans from family members and friends, placing them at risk 
for psychosocial and physical health problems and poor social and occupational functioning. As more women 
return from Iraq, Afghanistan, and neighboring countries, it is critical that researchers focus their attention on 
identifying effective brief counseling interventions for this population to enhance the quality of VA care for 
women Veterans and improve women’s psychosocial health.  
 
In particular, this study will directly inform efforts to improve care for women Veterans by focusing refinement 
and testing of an evidence-informed intervention. This is important for two primary reasons. First, as noted 
above, women Veterans are at high risk for IPV, and thus it is especially important that healthcare systems that 
treat women Veterans screen for IPV and offer evidence-based counseling for women who screen positive or 
otherwise disclose IPV. Second, the VA is the largest single provider of health care to women Veterans, so the 
current study’s findings will have particular relevance to the provision of care in VA for women who have 
experienced IPV. It is imperative that acceptable evidence-based counseling interventions become available in 
VA because the rates of women seeking VA care will continue to increase in coming years.  
 
(3)  Work Accomplished  
 
 
The PI, Dr. Iverson, has extensive experience in conducting IPV and treatment-related research.  Several of her 
prior studies were supported by a VA Health Services Research and Development (HSR&D) Services Career 
Development Award (HSR&D CDA2 10-029) entitled “Intimate Partner Violence, Health, and Health Care 
Among Women Veterans.” This CDA focused on delineating best practices for the IPV screening and 
immediate follow-up procedures.  Much of this work was conducted in collaboration with co-investigators on 
this study team. Some of this work (and that of co-investigators) is summarized in the next section, and 
provided the groundwork for the current proposal.  
 

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Understanding IPV experiences and expertise in implementing research findings in clinical practice: 
In several studies, using community- and Veteran-specific surveys, medical records reviews, and in-depth 
interviews, our team has documented the high prevalence of IPV among WVs6,8,10  as well as strong 
associations between IPV and WV’s physical and mental health.6,51-53 Dr. Iverson, a clinical psychologist with 
expertise in trauma-informed counseling, has conducted research to understand the broad scope of WVs’ 
cumulative experiences with trauma, including IPV, and the ways in which clinical response can effectively 
assist patients in recovering from trauma. This work has included understanding the role of coping skills among 
women who have experienced IPV54,55 and the ways in which prior trauma is associated with IPV risk.8,55,56 Dr. 
Iverson and colleagues (including Co-I’s Dichter, Gerber, Vogt, and Wiltsey-Stirman) have conducted research 
to inform an IPV screening program in VHA and collaborated with clinical/operations partners to facilitate the 
program’s implementation. Using mail-based surveys of WVs in VISN 1, Dr. Iverson validated a screening 
tool, the E-HITS, which VHA adopted for use in clinical programs.12,30 Drs. Iverson and Gerber conducted a 
quality improvement project that included input from VA patients and providers and three of this proposal’s 
VHA operational partners (WHS, CMSWS, and MHS) to develop and refine an IPV educational brochure for 
patients that has been disseminated nationally to all VAMCs.  
 
Development of RISE. 
Dr. Iverson used focus groups with WVs to understand patient perspectives on IPV screening and 
counseling in the healthcare setting. WVs expressed preferences for screening procedures and emphasized the 
importance of counseling interventions in response to IPV disclosures.31 WVs indicated that detecting IPV 
without offering follow-up intervention can increase patients’ self-blame. As one WV explained, “You can’t 
make the woman answer…but if she tells you and you don’t follow-up, then in the back of her mind, she’s 
saying, ‘Well, I told them and they don’t seem to care…I guess it’s just like he says. I deserve it.’” Focus 
groups with WVs identified factors that would facilitate the receipt of IPV counseling, including tailored 
approaches to counseling that recognize, in the words of one WV, that “everybody is at different stages of 
recovery, we’re all different, and may need different things.” Dr. Iverson’s qualitative work was followed by a 
web-based survey of a national sample of 411 WVs, 55% of whom experienced lifetime IPV.11,31,32 
Approximately 80% of WVs who experienced IPV indicated interest in receiving counseling for IPV in primary 
care and preferred it to be delivered in an individual format.11 Content priorities were physical safety, learning 
about the health effects of IPV, and enhancing coping skills and social support. To understand provider 
perspectives, Drs. Iverson and Dichter conducted in-depth interviews with VHA providers.30,32 Providers 
stressed the absence of follow-up interventions within VHA as a primary barrier to adoption of IPV screening. 
These study findings informed the individually-tailored, flexible, trauma-informed, modular approach used in 
RISE.  
Drs. Iverson, Gregor and Gerber developed the RISE manual based on an extensive review of the IPV 
intervention literature and the qualitative and quantitative findings detailed above, in accordance with 
intervention development standards.57 They have piloted RISE in their clinical work in primary care and mental 
health with a handful of patients, who have given positive qualitative feedback regarding acceptability and 
safety. For example, upon completing the Safety Planning module, one WV noted, “Using this handout to talk 
about safety is really useful...I can plan out what to do to protect myself and my dog when (partner) goes into a 
rage...It helps me feel like I have options.” Upon completing RISE, another WV shared, “I learned skills to help 
me deal with my situation differently.” Drs. Iverson also informally surveyed relevant VA providers. Feedback 

May 12th, 2020 
 
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from a DVC demonstrates the face validity and potential usefulness of RISE: “This type of protocol is really 
needed in VA. We don’t have anything like it, which is why screening is so inconsistent…I especially like that 
RISE is tailorable to the needs of the individual patient in front of you since you know how different each 
situation is.” Another provider suggests its acceptability to clinicians: “I love that patients get to choose what to 
focus on. I would be more likely to address IPV with patients if I used RISE rather than refer out.” Our VHA 
operations partners in WHS, CMSWS, and MHS also express support for the feasibility and acceptability of 
RISE. 
 
(4)  Work Proposed 
We will conduct a multi-method project with observational and interventional components and use a mixed 
methods analytic approach. This project is guided by REP’s pre-conditions and pre-implementation phases (see 
Figure 2 above). While phase 3 was initially intended to be multisite, due to feasibility and low enrollment 
problems at the VA Connecticut site (as evidenced by low participant recruitment and enrollment in Phase 2) 
we received a VA HSR&D Project modification to HSR&D to have Boston be the sole site for the RCT phase 
3. The timeline for all activities is provided in bullet points below.  
 
(a-b) Timeline/Key Questions/Study Sites  
 
 
Timeline for Proposed Research. 
• Phase 3 - Conduct RCT of RISE with WVs (n = up to 68) (Approximately September 2018- September 
2020; Dissemination and implementation activities in FY2021). 
 
Study Setting 
While Phase 3 was initially intended to be multisite, due to feasibility problem identified in phases 1 and 2, the 
RCT was conducted at VA Boston. In consultation with the DSMB, we have decided to discontinue 
involvement of VA Connecticut and continue the RCT solely at VA Boston to meet the primary objective of the 
study.  
 
 
Phase 3 
 
 
Specific Aims for Phase 3 Research: 
 
 
3. Examine the effects of RISE on WVs’ (n=60-68) individual psychosocial outcomes (e.g., 
empowerment, self-efficacy, health symptoms, service use, and quality of life) in an RCT that compares RISE 
to an information/referral condition.  
 
Sub-aim 3a. Evaluate the feasibility and acceptability of RISE in the context of the RCT.  
 
(c) Method and Data Analysis 
 
Aim 3 
 

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Randomized clinical trial (RCT): The goal of Aim 3 is to test the RISE intervention in comparison to an 
information/referral condition for women VA patients who have experienced past-year IPV. We selected a 
Hybrid Type 1 RCT design to evaluate the initial effectiveness RISE while gathering information on barriers 
and facilitators of implementation. We selected an information/referral comparison condition because a) this 
intervention is consistent with the current standard of care at the two study sites (and in the community); b) 
many other VA facilities are supposed to provide information and referrals for women who disclose IPV 
(according to VHA recommendations); and 3) an information/referral condition conforms to the US Preventive 
Services guidelines and to the suggestions of the Department of Health and Human Services. 29Participants will 
receive the information/referral condition for up to 60 minutes in order to standardize the comparison condition 
while also ensuring that women receive at least the minimum standard of care. At VA Boston, up to 68 female 
patients will be recruited and randomly assigned. Assuming 15% loss to follow-up based on current study 
estimates, we will aim to enroll 68 women to ensure sample size of  n=60 for participants with post-treatment 
and/or follow-up assessments (i.e., at least 2 data points). To address our sub-aim, providers will be invited to 
participate in brief (30-minute), semi-structured qualitative interviews toward the end of the RCT to provide 
perspective on RISE implementation.  
 
Female VHA patients: Eligibility, recruitment, and procedures 
Inclusion criteria are the same as the criteria that we have successfully adopted for Phase 2 of the study. 
Specifically, female VHA patients (n= 60-68) who meet the following inclusion criteria will be eligible to 
participate: (1) have experienced past-year IPV; (2) willingness to participate in pre-treatment, post-treatment 
and follow-up assessments (including questionnaires and post-treatment interviews), as well as to be randomly 
assigned to an intervention condition; (3) not at acute risk of suicide or homicide requiring hospitalization; (4) 
not demonstrating symptoms of mania, psychosis, or intoxication at the time of screening or sessions; (5) 
capacity to consent to study; (6) willingness to have the intervention session(s) audio recorded. Prior 
participation in the RISE open trial as part of Aim 2 will be an additional exclusion criteria, and during the 
COVID-19 pandemic while enrollment is solely virtual due to restrictions on face-to-face appointments, 
inability/unwillingness to do the enrollment session virtually so researchers can obtain a screenshot of the ICF, 
receive materials by mail, and/or provide personal email (i.e., to receive VVC appointment information, 
intervention materials) are additional exclusion criteria.   
 
Patient recruitment. We will include all of the same recruitment procedures we have used for Phase 2.  
Recruitment will include self-referrals (in response to advertisements posted in the VA or on social media or 
being informed of the study by a clinical provider), and the PI (KI) or project manager (Dr. Danitz) being 
added as an additional signer on notes in CPRS by providers who have patients who express interest in the 
study. This type of recruitment is common among active VA Boston treatment studies, including our Phase 2 
work. This is an ideal feature as it minimizes burden for interested patients and providers, while also 
mirroring how the interventions would ultimately be delivered in routine care. For clinic referrals, women who 
disclose IPV will be provided with care as usual at the two sites (e.g., provided with information/resources) and 
will be informed by their provider of the study opportunity. As we have done in Phase 2, in our efforts to inform 
providers and clinics about this study and referral pathways, we will remind clinicians to discuss the study 
opportunity with relevant patients (i.e., those who have experienced past-year IPV) in a non-coercive manner 
that maximizes safety of patients. We will provide clinicians with preferred language to document within the 
CPRS referrals. Specifically, when adding research staff as co-signers, we ask that clinicians note in CPRS that 
they discussed the “Women’s Treatment Preferences Study” as well as women’s preferred contact number and 
best/safest times to reach the patient. Clinicians may also state that the women veteran is interested in the 
Women’s Treatment Preferences Study but prefers to contact study staff directly, in which case women will be 
provided with study fliers. We will also post advertisements on Craigslist, as well as the Boston VA Twitter and 

May 12th, 2020 
 
11 
 
Facebook pages (see attached recruitment postings). We propose continuing to recruit in this way (i.e., via 
clinician referrals and social media postings) during the COVID-19 pandemic.  
 
Recruitment Letter Considerations:   
 
Our Co-I, Dr. Melissa Dichter, has conducted recent HSR&D-funded research at the Philadelphia 
VAMC and Portland VAMC to enlist women VA patients who have experienced past-year IPV.  She has 
developed safe and effective recruitment methods for recruiting that she has used in this work that we would 
like to apply for our study.  She has presented these recruitment methods on two national VA Cyber Seminars 
on recruiting women to participate in research (see her Power Point presentation attached). For their IPV study, 
they sent letters to women who had visits at the respective study sites within the past-year. These letters 
included vague language about a study to understand women’s interpersonal relationships and healthcare needs, 
direct mention of financial compensation, and invited women to “opt out” of being contacted. This strategy, 
although time consuming for the research team, was effective in securing their desired sample size of 160+ 
women who experienced past-year IPV. Of note, only 3.2% of the women who received letters opted out of 
being contacted. Of those who were reached by phone, there were only two women across the two study sites 
who indicated that they did not like being contacted for research by VA (but it was not specific to it being about 
IPV). It is notable that not one single woman expressed concerns to the interview team about being contacted 
via letters or phone using the opt-out method. We understand that VA Boston has been moving away from opt 
out strategies. However, we believe this method is highly appropriate for our study 
To balance concerns of IRB and what is effectively done in other related research, we propose to recruit 
via patient letters by contacting potential participants included on a patient list generated from the electronic 
medical records/CPRS (i.e., Corporate Data Warehouse), which will be saved in a password protected file in a 
secure drive behind the VA firewall. Potential participants on this list include women ages 18-55 who have had 
a primary care or mental health appointment at VA Boston within the past year. This letter is purposefully 
generic to protect the privacy and safety of women who receive the letter. The letter includes information about 
the voluntary nature of the study and the option to “opt out” from further contact by notifying us by phone or 
pre-stamped letter and self-addressed envelope. Women who do not opt out within 10 days of the letter being 
sent will be contacted. Women may contact us directly to learn more about the study and determine if they are 
eligible to participate. Our phone screen script includes necessary elements of consent and confirmation that 
women are in a private, safe space where they can speak before moving forward with the phone screening 
(please see phone screen script attached to this amendment). We will temporarily discontinue recruiting via 
letters during the COVID-19 pandemic and will plan to resume this previously approved recruitment strategy 
after stay at home orders are lifted and the study team returns to the VA Boston medical center. 
To augment these recruitment efforts, we will also recruit via flyers and brochures advertising the study 
opportunity in strategic locations within VA, including the Women’s Health Center and other key locations 
(e.g., mental health clinics, HUD-VASH, etc.). A previously approved submission included flyers and handouts, 
which contain information about the purpose of the study and phone number for learning more about the study. 
Interested women will have the option of meeting with study staff to learn more about the study and participate 
in eligibility screening. Women may also schedule a phone screening at a time that is convenient and safe for 
them.  
Upon contact with research staff, interested women will participate in a brief screening interview to 
determine eligibility (by phone for those who call and in-person for others), after which a member of the 
research team (PI, PM or RA) will examine patient’s electronic medical record to ensure that she does not meet 
exclusionary criteria (see attached list of exclusionary criteria to be examined in CPRS; any questionable 
criteria will be reviewed by PI and/or PM to determine eligibility). As per approved Phone Screening Script for 
Phase 3, study staff obtain verbal consent during the phone screening to mail a letter if the participant is unable 
to be reached by phone (please see patient letter in appendix). Ineligible women and those who decline 

May 12th, 2020 
 
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participation will be offered information on relevant resources within VA and the community (e.g., Passageway 
Program at Brigham and Women’s Hospital, National DV Hotline, etc.). Patients who meet inclusion criteria 
will be scheduled based on participant and provider availability as soon as possible, ideally within two weeks. 
At this visit they will fully review and sign informed consent documents and HIPAA Authorization (see 
Informed Consent document and HIPAA forms attached). Because women will be asked to complete 
questionnaires that include demographics information about themselves and IPV exposure, participants will 
complete the HIPAA authorization form. Patients will complete the pre-treatment assessment questionnaires 
(described below), after which patients will receive their randomly assigned 60-minute intervention session 
(RISE or information/referral, which is referred to as the “Make the Connection” intervention in the informed 
consent form). In some cases (particularly during the COVID-19 pandemic, given the requirement to not hold 
face to face meetings), informed consent will be conducted remotely rather than face to face appointment. In 
those situations, study staff will speak with potential study participants during the phone screening prior to their 
informed consent/enrollment appointment to ensure that is safe for participants to receive study materials in the 
mail, after which two copies of the informed consent (one for the study team, one for the participant to keep) 
will be mailed to the participant along with an addressed stamped envelope. During the phone screening, study 
staff will also confirm that it is safe for participants to receive emails, which will be used for telehealth 
appointments and the distribution of study materials. A videoconference session using VA-approved platforms 
(e.g., VVC) will be scheduled with the participant, during which the study team member reviews the ICF with 
the participant. If the participant agrees to sign the ICF, they will hold up the signed ICF page to the computer 
camera so the study team member can take a screen shot of the signed ICF. The screen shot will be saved 
directly to our secure project folder (in a file separate from any other data collection) as documentation of the 
signed ICF. The participant will be asked to mail the signed ICF back to the study team using the provided pre-
stamped addressed envelope. If the original signed ICF is received, it will be saved along with the printed 
screen shot picture of the signed ICF. 
 
Randomization and intervention delivery. 
 
Patients (women veterans) will be randomized within site to condition. Randomizing providers to only 
one condition risks that RISE delivery skill may be imbalanced across conditions. We recognize that when 
providers are involved in both conditions, provider learning may blend into both conditions (e.g., use of 
motivational interviewing (MI) skills for selecting RISE modules influencing information/referral delivery). We 
anticipate the risk of the latter is limited because the RISE materials explicitly prompt MI strategies whereas the 
comparison condition does not. Thus, providers will deliver both interventions. This will also allow providers to 
contrast RISE with a more minimal intervention when providing perspectives on feasibility and acceptability. 
We will record all sessions in both conditions and we will assess and monitor condition fidelity and treatment 
differentiation using adherence checklists that contain the critical RISE and the information/referral elements. 
We will use software to conduct a simple randomization process to assign women to an intervention condition. 
The individuals conducting the informed consent will not be aware of the participants assigned condition until 
the participant has completed the signed informed consent and HIPAA Waiver (assignment of condition will be 
in a sealed envelope). Although we had considered using stratified randomization to balance conditions on 
patient characteristics (e.g., age, IPV frequency), there is no a priori reason to expect such factors to 
significantly influence our primary outcomes, although we will include demographic/relationship factors as 
covariates in our analyses if demographic/relationship characteristics differ across groups (see Quantitative Data 
Analysis Plan below). During COVID-19, following the participant’s consent, the study team will email 
intervention materials to the participant for use during their same day intervention session.  
 
Information/referral intervention. The information/referral condition is referred to as the “Make the 
Connection” intervention in the informed consent form. The title of this intervention reflects some of the 
underlying purpose of the information/referral condition, which is to make the connection between IPV and 

May 12th, 2020 
 
13 
 
health, and finding out how to connect with resources that may be of use. Provision of education about IPV and 
resource information is considered the “standard of care” within VHA (and the community). Participation in 
this information/referral intervention consists of a one-time 60 minute brochure-based educational session. In 
this session, providers will walk through an IPV educational brochure with the participant (see attachment). 
This brochure was developed by Drs. Iverson and Gerber to guide clinician responses to IPV disclosures within 
VHA.  Using the brochure as a guide, the providers will provide tailored psychoeducation and discussions 
about: (1) the different forms of IPV (i.e. physical, sexual, psychological, etc.); (2) the effects of IPV on 
physical, mental, and social health; (3) discussion of safety planning; and (4) local and national IPV-related 
resources. Supportive statements and validation will be provided throughout (i.e., IPV is not your fault; I’m 
sorry this is happening to you). The provider will inquire about potential VHA ref errals that may be of interest 
to the woman, and place consults/make referrals as requested. Similarly, the provider will offer to make phone 
calls with the participant to any of the community resources that she may be interested in learning more about.  
The intervention will conclude ensuring the woman has the National Domestic Violence Hotline, and offer a 
discreet ‘wallet card’ for women who desire to take that information with them. They will be informed they will 
be contacted by phone to schedule their post-treatment assessments. Intervention sessions will occur in private 
office space within primary care and/or mental health (e.g., Women’s Division of the National Center for 
PTSD) or within a private location within the providers’ home during the COVID-19 crisis.  
 
RISE. The RISE will be delivered as per the refined manual, with its variable-length format (1 to up to 6 
sessions within an approximate 10 week period).  Following completion of the initial 60-minute RISE session, 
the provider and participant will determine whether they will have an additional session, and if so, it will be 
scheduled.  Because RISE is specifically designed to be variable-length and patient-centered, it is possible that a 
participant may only desire to have 1 RISE session.  Based on patient and provider feedback during Phase 2, all 
6 of the RISE sessions can be up to 60 minutes. Originally, the subsequent sessions were intended to be 30-40 
minutes, but that has proved infeasible. Both patients and providers have suggested that more time is allotted for 
subsequent sessions. Participants may have up to 6 RISE sessions in total. Intervention sessions will occur in 
private office space within primary care and/or mental health (e.g., Women’s Division of the National Center 
for PTSD). During times of unforeseen circumstances, such as the COVID-19 public health crisis of 2020, the 
clinical research sessions will be offered in telehealth format from the homes of licensed clinical psychologists 
Dr. Sara Danitz and Dr. Laura Brennan, ensuring safe and private conditions for both the interventionists and 
the participants by following VA Boston’s and national VVC guidance for such clinical care.  Individuals in the 
RISE condition will also complete the four brief validated self-report measures of empowerment, self-efficacy, 
patient activation, and valued action at the beginning of each RISE session to gauge treatment progress in real 
time and guide module selection, as we have done in Phase 2. Note these measures will be collected by the 
interventionist over the phone for any telehealth visits.  This process takes approximately 10 minutes (leaving 
approximately 50 minutes for the RISE session). Participants will initially be emailed RISE intervention 
materials following their consenting/enrollment session, after which they will have the option to receive RISE 
intervention materials via USPS mail.  
 
Female VHA Patient Assessments. Data collection takes place throughout the study and is modeled after a 
prototypical Hybrid 1 trial 50. We will administer a full battery of psychosocial assessment at pre-treatment, 
post-treatment assessment (i.e., 10-weeks post enrollment), and 1 month follow-up (i.e., 14 weeks post-
enrollment) described below under “Measures.”  Participants in the RISE condition will also complete four brief 
measures of empowerment, self-efficacy, patient activation and valued action at the beginning of each RISE 
session.  At the posttreatment and follow-up assessment, patients will complete a brief audio-recorded semi-
structured interview about their experiences with their respective intervention. The post-treatment and follow-
up assessments will either be conducted by phone or in person, depending on the participant’s preference (thus 
allowing for them to determine what is most safe and preferable for them). Women will be compensated with 

May 12th, 2020 
 
14 
 
$25 for completing the pre-treatment assessment. Upon completion of the post-treatment assessment, women 
will receive $50 in cash or by check for their time and participation. Upon completion of the follow-up 
assessment, women will receive a $75 in cash or by check for their time and participation. A timeline of all 
measures is available below in Table 4. 
 
 
VHA providers: Eligibility, recruitment, and procedures. 
There will be at least 2-4 VA providers at each of the two sites (n=4-8 total), and following the discontinuation 
of the VA Connecticut-West Haven Site, there will be at least 2-4 VA providers at VA Boston. Various types of 
providers will be included (e.g. psychologists, social workers). Providers will participate in training on RISE 
and the information/referral condition, providers will audiotape their sessions and participate in weekly 
consultation. Providers will also have the option to enroll and participate in a 30-minute phone interview near 
the end of the RCT in order to help us learn about the acceptability and feasibility of implementing RISE in VA, 
including barriers and facilitators to RISE implementation and completion of two brief quantitative measures 
regarding the perceptions of the intervention and its implementation (“described under Measures”). These 
interviews will be brief (approximately 30 minutes), audio recorded, and administered by a trained/qualified 
Project Manager, PI (Iverson) or Research Assistant via telephone. The interviews will be recorded and 
transcribed. We recognize that VA employees are a vulnerable population and will take special care to ensure 
that participants understand that their participation is completely voluntary and will not affect their VA 
employment in any way (see additional details under Potential Risks and Adequacy of Protection Against Risk). 
VA providers can be of any gender, age, and racial/ethnic background.  
 
Measures 
 
For Women VA Patient Participants:  
 
Table 4. Timeline of Assessments  
Pre 
10-week 
14-week 
 
 
 
 
Demographics (age, race, sexual orientation, # deployments) 
X 
 
 
Demographics (relationship status, housing status) 
X 
X 
X 
Personal Progress Scale 
X 
X 
X 
Patient Activation Measure- Short Form (PAM-13) 
X 
X 
X 
Valued Living Questionnaire (VLQ) 
X 
X 
X 
Center for Epidemiological Studies- Depression Scale (CES-D) 
X 
X 
X 
Health Service Use 
X 
X 
X 
The Conflict Tactics Scale-Revised (CTS-2) 
X 
X 
X 
PTSD Checklist for DSM-5 (PCL-5) 
X 
X 
X 
Patient Health Questionnaire- 15 (PHQ-15) 
X 
X 
X 
12-item Short Form Survey (SF-12) 
X 
X 
X 
Safety Behaviors Checklist (SBC) 
X 
X 
X 
Connor-Davidson Resilience Scale (CD-RISC 25) 
X 
X 
X 
Client Satisfaction Questionnaire 8 (CSQ-8) 
X 
X 
X 
Depression Anxiety Stress Scale- (DASS) 
X 
X 
X 
Coping Strategy Inventory-Short Form (CSI-SF) 
X 
X 
X 
Acceptability 
   X 
   X 
  IPV-Related Head Injury 
    X 

May 12th, 2020 
 
15 
 
Demographics: A brief measure of background information (e.g., age, race, sexual orientation, relationship 
status, number of deployments, housing status). Background information surrounding age, race, sexual 
orientation, and number of deployments will be collected at Pre, while demographic information on relationship 
status and housing status will be collected at all three timepoints (table 4). 
 
Personal Progress Scale – Revised35: A measure of empowerment in women, demonstrating excellent reliability 
and validity in diverse sample of women. 
 
General Self-efficacy Scale (GSS)65a: A reliable and valid 10-item scale that is designed to assess optimistic 
self-beliefs to cope with a variety of difficult demands in life. 
 
Patient Activation Measure-Short Form (PAM-13)65b: A brief validated measure of patient activation including: 
patient knowledge, skill, and confidence for self-management. The 13-item abbreviated measure has 
psychometric properties similar to the original 22-item version. 
 
Valued Living Questionnaire (VLQ)66: The VLQ is a two-part questionnaire that measures (a) the importance of 
10 valued areas of living, and (b) the extent to which one’s actions are consistent with one’s values. For each 
domain (e.g., family, physical self-care, friends/social life), respondents use a 1–10 scale to rate how important 
each value is to them and how consistently they have lived in accordance with this value over the past week. 
Responses from both importance and consistency are multiplied to derive a value composite score. 
 
Center for Epidemiologic Studies – Depression Scale (CES-D)67: The CES-D is a psychometrically sound and 
widely-used 20-item questionnaire designed to measure the frequency of past-week depressive symptoms. It is 
sensitive to change over relatively short periods of time. 
 
Health Service Use (HSU)68: Assesses VA and non-VA health service use using a modified version of Dr. 
Dawne Vogt’s health service use (HSU) measure. This measure has been used in prior studies by Dr. Vogt 
(HSR&D IIR 12-345) and has been modified slightly for the purposes of this study. This will allow us to 
examine whether RISE leads to increased access and engagement with relevant health services. 
 
The Conflict Tactics Scale-Revised (CTS-2)69: is a 39-item, behaviorally specific measure of intimate partner 
conflict, including physical, sexual, and psychological IPV.  This measure has strong psychometric properties70 
and is the most commonly-used measure of IPV. This measure will be used to assess the scope of past-year IPV 
experiences in this sample. 
 
PTSD Checklist for DSM-5 (PCL-5)70: The PCL-5 assesses the 20 DSM-5 symptoms of posttraumatic stress 
disorder. 
 
15-item Patient Health Questionnaire (PHQ-15)71: The PHQ-15 assesses somatic symptoms by asking patients 
whether symptoms are present and the extent of their severity on a scale from 1 (not bothered at all) to 3 
(bothered a lot). 
 

May 12th, 2020 
 
16 
 
12-item Short Form Survey (SF-12)72: The SF-12 assesses health-related quality of life with questions regarding 
patients’ abilities to perform their usual activities. The measure includes two subscales for physical and mental 
health. 
 
Safety Behaviors Checklist (SBC)73: The SBC assesses patients’ behaviors to safeguard themselves against 
intimate partner violence and plan escape from an intimate partner, including such items as “Have you ever 
hidden money?” and “Do you have a hidden bag with extra clothing available?”  
 
Connor-Davidson Resilience Scale (CD-RISC 25)74-75: The CD-RISC 25 is a validated self-report measure of 
resilience (Campbell-Sills & Stein, 2007). Items include statements about one’s response to stress in the domains of 
control, commitment, hardiness, goal-orientation, self-esteem, adaptability, social skills, humor, strengthening through 
stress, and endurance of pain. Participants were asked to rate their level of agreement on a 5-point Likert scale from “not 
true at all” to “true nearly all the time” to items such as “I am able to adapt when changes occur.” The summed resilience 
scores range from 0-40, with higher scores indicating greater resilience. The CD-RISC 25 is considered a high-quality 
resilience scale with acceptable psychometric support (Windle, Bennett, & Noyes, 2011). This measure has been used 
both in studies that conceptualize resilience as a stable, within-person trait, and as a modifiable construct. 
Client Satisfaction Questionnaire-8 (CSQ-8)76: The CSQ-8 evaluates patients’ satisfaction with the service they 
received (i.e., RISE or the information/referral), with items including “How satisfied are you with the amount of 
help you have received?” and “If you were to seek help again, would you come back to our program?” (post-
treatment and 1 month follow-up only). 
 
Depression Anxiety Stress Scale (DASS) (DASS-Anxiety Subscale)77: The anxiety subscale contains 14 items 
which assess autonomic, skeletal muscle effects, situational anxiety, and subjective experiences of anxious 
affect. 4-point severity/frequency scales are used and summed.  The DASS has been shown to have high 
internal consistency and yield meaningful discriminations in a variety of settings (Loviband & Loviband, 1995). 
Coping Strategy Inventory- Short Form (CSI-SF) 78-79: The CSI-SF was structured to reflect the original CSI 
scale, with four 4- item subscales: (a) Problem–Focused Engagement, (b) Problem-Focused Disengagement, (c) 
Emotion-Focused Engagement, and (d) Emotion-Focused Disengagement. Respondents were asked to rate the 
general frequency with which they utilize each listed coping strategy on the survey and to indicate their choices 
in the following manner: 1 = “Never”, 2 = “Seldom”, 3 = “Sometimes”, 4 = “Often” and 5 = “Almost Always”. 
Individuals receive scores for each first-tier subscale (Engagement vs.  Disengagement: range = 8 – 40), as well 
as for each of the four second tier subscales (Problem-Focused Engagement, Problem-Focused Disengagement, 
Emotion-Focused Engagement, and Emotion-Focused Disengagement: range = 4 – 20). Each of the four 2nd 
tier subscales created contained four items each. The CSI-SF demonstrates reliability and validity.  
 
Acceptability: Brief qualitative and semi-structured interview questions assess patients’ perceptions of the 
feasibility and acceptability of their respective intervention (post-treatment and 1-month follow-up only). 
 
Military sexual trauma (MST)85:  MST will be measured with the two following dichotomous (yes/no) VA 
clinical reminder items:  “When you were in the military… a)  did you ever receive unwanted, threatening, or 
repeated sexual attention (for example, touching, cornering, pressure for sexual favors, or inappropriate verbal 
remarks, etc.?;  b) did you have sexual contact against your will or when you were unable to say no (for 
example, after being forced or threatened or to avoid other consequences)?”  Evaluation of these items against 

May 12th, 2020 
 
17 
 
clinical interview yielded a sensitivity of .92 and specificity of .89 for the first question and a sensitivity of .89 
and specificity of .90 for the second question (McIntyre et al., 1999).  
 
Combat exposure: We developed a single dichotomous (yes/no) item to assess exposure to combat: “During any 
of your deployments, did you have any exposure to combat (for example, you fired a weapon, were under fire, 
or saw people who were injured or killed in battle)?” Only those participants who indicate that they have been 
deployed will be prompted to complete this question. 
 
IPV-Related Head Injury86:  We adapted the VA-DoD TBI screener to assess a history of IPV-related head 
injuries, probable TBI history, and TBI-related sequelae (Donnelly et al., 2011).  Because concussion is a 
relatively common consequence of IPV to the face or head. We would like to assess whether IPV-related TBI 
history, with or without current symptoms, attenuates the effectiveness of treatment. It may be an important area 
to address as part of counseling for women who have experienced IPV. This 4-item screener allows us to 
determine probable IPV-related TBI history, with and without current symptoms. Studies using this measure 
suggests its utility in determining IPV-related TBI history among a sample of women Veterans (e.g., Iverson & 
Pogoda, 2015).   
 
Quantitative Data Analyses (Aim 3) 
We will conduct multilevel longitudinal data analyses to examine change in psychosocial outcomes. Time will 
be coded as 0, 1, and 2 respectively for pretreatment, posttreatment, and 1-month follow-up; therefore, the 
Level-1 intercept will represent initial status and the Level-2 time coefficient will represent change over time. 
We will also evaluate a model using linear and quadratic polynomial contrasts and orthogonal contrasts to 
evaluate non-linear (i.e., non-constant) change. We will add a dummy-coded intervention variable (RISE vs. 
information/referral condition) as a predictor of the Level-1 change parameters (initial status and change over 
time) to evaluate the treatment x time interaction (i.e., does group membership moderate change in the 
outcomes?). This analytic strategy will produce effective and efficient tests of change in outcomes, even in the 
presence of attrition, and provides us with flexibility to assess and adjust for control variables, if needed (e.g., 
age, IPV frequency). We will calculate effect size estimates and 95% confidence intervals, which produce an 
estimate of d from multilevel analyses that is comparable to d’s produced using traditional methods (e.g., 
repeated measures ANOVA). To examine the range of effect sizes that might be reasonable to expect in a future 
trial, we will calculate effect sizes and 95% confidence intervals for all of our primary and secondary outcomes. 
The study will incorporate a 2 x 3 (Condition: RISE vs. information/referral x Time: pretreatment, post, and 1-
month follow-up) mixed-factorial multi-measurement design producing N=60 x 3 time points=180 
measurement observations (or up to N=68 x 3 timepoints = 204). The intervention in this study is a difference 
over and above standard care (not in isolation), so it is expected that the effect will be modest (d=.5, f 2=.15, 
PV=.1). Traditional approaches to repeated measures can thus be used to assess power. However, the design 
affords two alternate methods. The interaction term from the multilevel model will have 118 degrees of 
freedom, given the study design, which is more than sufficient to render a power = .95 for the primary 
outcomes. A simulation was also conducted leveraging the inputs from the prior studies, assuming a modest 
effect size, to determine power. In all simulated conditions, power is estimated >.80 for primary outcomes. 
Consistent with the American Statistical Association recommendations, we will examine effect sizes and 95% 
confidence intervals, along with p-values in our tests.   
We will assess the feasibility and acceptability of RISE and the comparison condition by looking for consistent 
patterns in rates of intervention attendance (i.e., number of RISE sessions attended) and reasons for RISE 
termination. We will examine the acceptability of both interventions using data from the CSQ-8 and qualitative 
data from patient interviews. Provider quantitative measures of feasibility and acceptability will be primarily 

May 12th, 2020 
 
18 
 
descriptive in nature, including mean summary scores and proportion of participants rating the intervention as 
feasible and acceptable. Lower scores will indicate a need to examine a given dimension more closely. We will 
integrate qualitative analyses within the quantitative analyses for the purposes of expansion, development, and 
convergence.  
Qualitative Data Analyses (Aim 3) 
Interview data will be analyzed using rapid methods. These data will be used to contextualize and interpret 
quantitative findings, including identification of barriers to and facilitators of RISE implementation to inform 
future research. Rapid content analysis allows for a quick and accurate reduction of qualitative data and 
produces results useful for efficient intervention refinement. Exit interviews with women veterans will be 
digitally recorded and transcribed verbatim for analysis. We will use Co-I Dr. Hamilton’s established rapid 
content analysis approach to efficiently derive key findings from transcripts to tailor and refine the RISE 
manual and implementation protocol.66 In this approach, data analysis occurs concurrently with data collection. 
As transcripts become available, they will be reviewed and summarized by members of the research team using 
structured templates organized by key topics from the interview guides. Consistent with our team’s successful 
approach across multiple prior projects, we will transfer the summaries into matrices and use matrix analysis 
methods to identify themes related to the intervention and implementation.78 Matrices streamline the process of 
noting simultaneously and systematically similarities, differences, and trends in responses across groups of 
informants. Matrix analysis facilitates the discovery of relationships and patterns, expediting synthesis and 
summary.78 The process begins with review of available transcripts by study team members, making notes of key 
themes and impressions. Team members meet to discuss comparison and generate an initial coding manual and 
matrices for summary of emergent findings based on inductive and deductive approaches. Using constant 
comparison, each item will be checked or compared with the rest of the data to establish analytic categories thus 
allowing for reflection of the nuances of the data. Dr. Iverson will update the coding model as the analyses lead to 
further refinement. Once interrater reliability is achieved, 20% of transcripts will be coded by at least two 
individuals to ensure interrater reliability is still being achieved and to  avoid coder “drift”. Dr. Iverson has 
significant experience with qualitative and mixed method data analysis and interpretation, with experience in 
rapid content analysis to modify interventions. She will oversee all qualitative and mixed method analyses, with 
help from a trained and qualified project manager (PM; Dr. Danitz), with consultation from Dr. Hamilton. Dr. 
Iverson, Dr. Danitz, and RA will have primary responsibility for analyzing the qualitative data.  
 
4.d Potential Limitations and Solutions to Limitations.  
Recruitment  
Recruitment of Female VA Patients (Aim 3). As noted above, we will use a variety of recruitment 
methods, including clinic referrals and self-referrals based on flyers and social media postings, and mailed 
letters. These referrals may result from spontaneous disclosure or routine IPV screening. Screening does not, 
however, always lead to disclosure. In the event that we have difficulty meeting our enrollment goals, we will 
broaden our recruitment efforts. Dr. Iverson will troubleshoot problems with recruitment procedures with Co-
Investigators and, with IRB approval, implement recommended strategies as needed (e.g., actively recruit and 
conduct intervention at the Brockton campus).  
 Based on our experience with recruitment in Phase 2, we recognize the need to broaden our letter 
recruitment strategy. In order to do mail recruitment from a list of potential participants generated from VA 

May 12th, 2020 
 
19 
 
administrative data, we will collect the following data on potential study participants prior to receiving informed 
consent: name, mailing address, telephone number, and medical record/social security number. This information 
will be necessary to recruit participants, and the HIPAA Waiver of Authorization (attached) reflects this 
additional recruitment method. Research staff will mail a recruitment letter to potentially eligible patients, 
asking patients to contact research staff with questions and/or to indicate their interest in participating in the 
study, or to opt out of further contact if they do not wish to participate in the study (Aim 3 only). We will 
provide phone numbers and a self-addressed letter and stamped self-addressed envelope for opting out to make 
this process as easy as possible for  women. All recruitment materials are intentionally vague (i.e., no mention 
of IPV or study focus) for safety purposes. Patients who contact research staff will be asked if they are in a 
space where they can speak privately. Once confirmed, research staff will describe the purpose of the study and 
what study participation entails, explain eligibility criteria, determine eligibility, and ask the participant (if 
eligible) if she is interested in participating. If yes, research staff will record the patient’s name and preferred 
contact number. If patients do not respond to the recruitment letter, they will be contacted by study staff.  
Data Analyses for Aim 3 
 
Qualitative. The rapid qualitative analyses are time and resource intensive. As such, Dr. Iverson has 
budgeted for a full-time project manager and research assistant to ensure timely transcription and analyses of 
interview data. The coding team will hold weekly meetings focus on analysis and thematic summaries in order 
to stay on track with the timeline of this study. If additional resources are needed for transcribing focus groups 
and interview data, and/or for coding, Dr. Iverson may be able to request additional resources through the 
Women’s Health Sciences Division of the National Center for PTSD and the Center for Healthcare 
Organization and Implementation Research (e.g., additional PM or RA time for participation in qualitative 
analysis team). Any such changes would undergo IRB approval prior to initiation of protocol modifications or 
additions to the team. 
 
Quantitative. RISE is designed to be variable-length, with a special focus on empowering women to 
choose which modules, and relatedly, how many sessions (with an upper limit of 6) are right for her situation 
and needs. Thus, it is possible that some women may only desire or be able to attend one session, and therefore 
may only have quantitative data two assessment periods (i.e., pretreatment and posttreatment). We view this 
pre-post data as acceptable, as this is a pilot test and we will still be able to examine general levels of 
improvement on outcomes. In addition to examining changes in quantitative variables over time at the group-
level, we will be able to graphically examine individual women’s trajectories, which will further enable us to 
meet our Aim 2 goals. That being said, we do expect that the majority of participants will opt for multiple 
sessions based on the feedback we’ve received in Phase 1 focus groups with women VA patients.  Part of the 
purpose of this open trial will be to begin to understand how many sessions (and which types of modules) 
women choose to inform the implementation protocol for the RCT in Phase 3.  
 
Subjects and generalizability. While the findings from this study will be highly informative, they will 
not be definitive. Our RCT design for Phase 3 provides a strong test of RISE, controlling for any spontaneous 
changes in outcomes (e.g., Hawthorne effect) and enabling comparison of changes observed in patient outcomes 
during RISE to what we observe in the information/referral condition. This increases confidence that changes 
observed in the RISE condition are a result of the intervention, as opposed to assessment or contact with project 
personnel. Generalizability will, however, be limited due to the use of only one site. The effectiveness of RISE 
will need to be more rigorously evaluated in a larger study with a diverse array of WVs (e.g., rural women, 
racial/ethnic minorities). In the likely event that RISE demonstrates effectiveness, we will submit a subsequent 
IIR employing a multi-site RCT that is fully powered to evaluate a range of psychosocial outcomes using an 
effectiveness-implementation Hybrid 2 design. This will allow us to more comprehensively evaluate RISE with 
a diverse array of women Veterans (e.g., rural women, racial/ethnic minorities) and providers while also 

May 12th, 2020 
 
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evaluating implementation strategies. Additionally, this study focuses on refining and evaluating RISE for 
WVs. Although we will not be able to confidently generalize results to male patients or non-VHA settings, the 
findings will likely hold implications for men and could be applied to other health care settings in future studies. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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