Clinical trial NCT03261700: Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE)
Official title: Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE): Tailoring and Evaluating a Patient-Centered Counseling Intervention for Women Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Self-efficacy
Keywords: women Veterans
interpersonal violence
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Boston Healthcare System
First posted: 2017-08-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For the RCT (Aim 3), participants will be randomized to RISE or an information and referral condition.
Primary purpose: TREATMENT

Brief summary: 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

* safety planning;
* education on the health effects of IPV and warning signs;
* increasing coping skills and self-care;
* enhancing social support;
* making difficult decisions; and
* connecting with resources. This study is aimed at refining and evaluating RISE for use with female VA patients who have experienced past-year IPV. This brief counseling intervention is intended to be administered in conjunction with primary care, as this is a frequent point of healthcare contact for women Veterans and where disclosure of IPV is most prevalent.

Detailed description: Women are the fastest growing group of VHA patients, with their population recently increasing by 80%. Women Veterans (WV's) are at higher risk for IPV than their non-Veteran peers, with that 1 in 3 WVs report lifetime IPV, compared to 1 in 4 women in the general U.S. population. Research reports up to 30% of WVs experience past-year IPV. As a result, WVs are considered an important population for IPV screening and counseling interventions. 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. Extant brief counseling interventions for IPV result in minimal effects on patients' health and safety. 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. 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, especially for delivery in conjunction with primary care. The Recovering from IPV through Strengths and Empowerment (RISE) intervention fills this need.

The PI, a clinical psychologist and health services researcher with expertise in and national recognition for IPV research and care, has developed an innovative IPV intervention to respond to this need. Recovering from IPV through Strengths and Empowerment (RISE) is based on the healthcare needs and preferences of WVs who have experienced IPV. RISE was developed using rigorous methods, building on the evidence base from the applicant's HSR\&D CDA and on input of VHA primary care and behavioral health experts. RISE is based on empowerment, a highly relevant intervention model for women who experience IPV. It is an individualized, variable-length, modular-based intervention addressing key factors:

* safety planning,
* educating about the health effects of IPV and warning signs,
* improving coping and self-care,
* enhancing social support,
* making difficult decisions, and
* connecting with resources. RISE is rooted in empowerment and incorporates aspects of Motivational Interviewing, an evidence-based approach designed to facilitate behavior change that is widely used in VHA for numerous health issues.

This timely research project addresses the critical gap in current IPV care. It will refine and formally evaluate RISE using established methods for rapid and efficient effectiveness testing, including a Hybrid 1 randomized clinical trial (RCT) to evaluate RISE that simultaneously gathers information on barriers to and facilitators of implementation. The study is guided by the first two phases of the Replicating Effective Programs (REP) framework, pre-conditions and pre-implementation. These phases emphasize tailoring interventions with stakeholder input and iterative cycles of pilot testing within routine practice conditions. Use of the REP framework will maximize the likelihood that RISE-should its effectiveness be demonstrated-can easily be integrated into routine care in VHA.

The Specific Aims of this study are as follows:

1. Tailor and refine RISE to accommodate differences in service structures and personnel in different primary care settings through input from a Stakeholder Advisory Board, focus groups with WVs (four groups; n=24-32), and qualitative interviews with providers (n=24).
2. Conduct a formative evaluation of RISE with WVs (n=up to 20) to inform the development of a user-friendly, tailored implementation protocol and intervention manual.
3. Examine the effects of RISE on WVs' (n=60) 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.

3a. Evaluate the feasibility and acceptability of RISE in the context of the RCT.

This study provides the groundwork to examine the effectiveness of RISE. The data will be used to demonstrate whether the effects of RISE appear promising to support a future-large scale effectiveness-implementation RCT, including the range of effect sizes that would be reasonable to expect in a future trial.

The project was originally conducted at two Women's Health Practice-Based Research Network (PBRN) sites that have adopted IPV screening - the Women's Health Centers (WHC) at VA Boston Healthcare System and VA Connecticut Healthcare System. RCT study enrollment was discontinued at VA Connecticut in July 2019 due to low enrollment. The VA Boston Healthcare System serves as the sole site for data collection from July 2019 on and is the sourced of the RCT data.

The COVID-19 pandemic resulted in modifications to IRB protocol to switch from in-person enrollment, assessments and sessions. There were several women actively involved in the trial during the initial shut-down. New recruitment and enrollment were temporarily hauled during early months of COVID-19, with virtual enrollment beginning as of July 2020.

Recruitment and enrollment were completed in September 2020 because the enrollment goals were met and the planned sample size was obtained (N=60).

Eligibility criteria: Inclusion Criteria:

Participants will be eligible to participate if they:

* Self-identify as a woman
* Are at least 18 years of age
* A patient at VA Boston Healthcare System
* Self- reported that they have experienced past-year physical, sexual, or psychological IPV
* Ability to understand study procedures in English
* Not exhibiting symptoms of mania or psychosis
* Not actively in suicidal crisis warranting imminent hospitalization

Exclusion Criteria:

* Any violation of inclusion criteria

Primary outcomes:
measure: Empowerment Via the Personal Progress Scale Revised
timeFrame: Baseline,10-week follow-up, and 14-week follow-up assessments
measure: Self-efficacy Via the General Self-Efficacy Scale
timeFrame: Baseline, 10-week follow-up, and 14-week follow-up assessments
measure: Valued Living Questionnaire
timeFrame: Baseline, 10-week follow-up, and 14-week follow-up assessments
measure: Patient Activation Measure (PAM-13)
timeFrame: Baseline, 10-week follow-up, and 14-week follow-up assessments
Secondary outcomes:
measure: PTSD Checklist for DSM-5
timeFrame: Baseline, 10-week follow-up, and 14-week follow-up assessments
measure: Center for Epidemiological Studies-Depression Scale
timeFrame: Baseline, 10-week follow-up, and 14-week follow-up assessments
measure: SF-12 Health Survey
timeFrame: Baseline, 10-Week follow-up, and 14-Week follow-up Assessments
measure: Conflict Tactic Scales Revised
timeFrame: Baseline, 10-week follow-up, and 14-week follow-up assessments
measure: Physical, Mental and Social Service Care Use
timeFrame: Baseline, 10-week follow-up, and 14-week follow-up assessments
measure: Client Services Questionnaire (CSQ-8)
timeFrame: 10-week follow-up assessment
measure: Patient Health Questionnaire
timeFrame: Baseline, 10-week follow-up, and 14-week follow-up assessments
measure: Safety Behaviors Checklist
timeFrame: Baseline, 10-week follow-up, and 14-week follow-up assessments
measure: Connor-Davidson Resilience Scale
timeFrame: Baseline, 10-week follow-up, and 14-week follow-up assessments
measure: Depression Anxiety Stress Scale- Anxiety Subscale
timeFrame: Baseline, 10-week follow-up, and 14-week follow-up assessments
measure: Coping Strategies Inventory - Short Form
timeFrame: Baseline, 10-week follow-up, and 14-week follow-up assessments
measure: Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.
timeFrame: Assessed at 10-week follow-up or 14-week follow-up, values at the end of 14 weeks reported
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Katherine M. Iverson, PhD MA BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dardis CM, Dichter ME, Iverson KM. Empowerment, PTSD and revictimization among women who have experienced intimate partner violence. Psychiatry Res. 2018 Aug;266:103-110. doi: 10.1016/j.psychres.2018.05.034. Epub 2018 May 30.
citation: Grillo AR, Danitz SB, Dichter ME, Driscoll MA, Gerber MR, Hamilton AB, Wiltsey-Stirman S, Iverson KM. Strides Toward Recovery From Intimate Partner Violence: Elucidating Patient-Centered Outcomes to Optimize a Brief Counseling Intervention for Women. J Interpers Violence. 2021 Aug;36(15-16):NP8431-NP8453. doi: 10.1177/0886260519840408. Epub 2019 Apr 17.
citation: Iverson KM, Dardis CM, Grillo AR, Galovski TE, Pogoda TK. Associations between traumatic brain injury from intimate partner violence and future psychosocial health risks in women. Compr Psychiatry. 2019 Jul;92:13-21. doi: 10.1016/j.comppsych.2019.05.001. Epub 2019 May 14.
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citation: Iverson KM, Danitz SB, Driscoll M, Vogt D, Hamilton AB, Gerber MR, Wiltsey Stirman S, Shayani DR, Suvak MK, Dichter ME. Recovering from intimate partner violence through Strengths and Empowerment (RISE): Development, pilot testing, and refinement of a patient-centered brief counseling intervention for women. Psychol Serv. 2022;19(Suppl 2):102-112. doi: 10.1037/ser0000544. Epub 2021 Jun 10.
citation: Iverson KM, Danitz SB, Shayani DR, Vogt D, Stirman SW, Hamilton AB, Mahoney CT, Gerber MR, Dichter ME. Recovering From Intimate Partner Violence Through Strengths and Empowerment: Findings From a Randomized Clinical Trial. J Clin Psychiatry. 2021 Nov 23;83(1):21m14041. doi: 10.4088/JCP.21m14041.
citation: Shayani DR, Danitz SB, Low SK, Hamilton AB, Iverson KM. Women Tell All: A Comparative Thematic Analysis of Women's Perspectives on Two Brief Counseling Interventions for Intimate Partner Violence. Int J Environ Res Public Health. 2022 Feb 22;19(5):2513. doi: 10.3390/ijerph19052513.
citation: Davin KR, Dardis CM, Barth MR, Iverson KM. Prospective mental health effects of intimate partner stalking among women veterans. Psychol Trauma. 2022 Jul;14(5):751-758. doi: 10.1037/tra0001144. Epub 2021 Nov 4.
citation: Iverson KM, Dardis CM, Cowlishaw S, Webermann AR, Shayani DR, Dichter ME, Mitchell KS, Mattocks KM, Gerber MR, Portnoy GR. Effects of Intimate Partner Violence During COVID-19 and Pandemic-Related Stress on the Mental and Physical Health of Women Veterans. J Gen Intern Med. 2022 Sep;37(Suppl 3):724-733. doi: 10.1007/s11606-022-07589-z. Epub 2022 Aug 30.
citation: Webermann AR, Dardis CM, Iverson KM. The role of general self-efficacy in intimate partner violence and symptoms of posttraumatic stress disorder among women veterans. J Trauma Stress. 2022 Jun;35(3):868-878. doi: 10.1002/jts.22794. Epub 2022 Jan 31.