Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE)

Intimate Partner Violence Clinical Trial

— RISE  

Official title:

Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE): Tailoring and Evaluating a Patient-Centered Counseling Intervention for Women Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03261700
• Other study ID #: IIR 16-062
• Secondary ID: 1I01HX002178-01A
• Status: Completed
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: November 23, 2020

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 23, 2020
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intimate Partner Violence
• Self-efficacy

Intervention

Behavioral:
• RISE
This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.

Other:
• Information and referral condition
Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (10)

Danitz SB, Stirman SW, Grillo AR, Dichter ME, Driscoll M, Gerber MR, Gregor K, Hamilton AB, Iverson KM. When user-centered design meets implementation science: integrating provider perspectives in the development of an intimate partner violence intervention for women treated in the United States' largest integrated healthcare system. BMC Womens Health. 2019 Nov 27;19(1):145. doi: 10.1186/s12905-019-0837-8. — View 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. — View 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. — View 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. — View 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. — View 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;8 — View 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 — View 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. — View 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. d — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Empowerment Via the Personal Progress Scale Revised	Measures change in sense of personal empowerment; minimum value = 28 and maximum score = 196; higher scores indicate higher personal empowerment	Baseline,10-week follow-up, and 14-week follow-up assessments
Primary	Self-efficacy Via the General Self-Efficacy Scale	This scale is a self-report of change in general self-efficacy; minimum score = 4 and maximum score = 40; higher scores indicate higher self-efficacy	Baseline, 10-week follow-up, and 14-week follow-up assessments
Primary	Valued Living Questionnaire	Measures change in valued living, and congruence between stated values and past-week valued behavior; Composite scores range from 10 (minimum) to 100 (maximum). Higher scores reflect higher valued living (i.e., an indicator of higher quality of life)	Baseline, 10-week follow-up, and 14-week follow-up assessments
Primary	Patient Activation Measure (PAM-13)	Measures change in patient engagement in needed health care; scores are transferred to a theoretical 0-100 scale; higher scores indicate higher patient activation.	Baseline, 10-week follow-up, and 14-week follow-up assessments
Secondary	PTSD Checklist for DSM-5	Measures change in DSM-5 PTSD symptom severity. Scores range from 0-80; higher scores reflect higher/worse PTSD symptoms.	Baseline, 10-week follow-up, and 14-week follow-up assessments
Secondary	Center for Epidemiological Studies-Depression Scale	Measures change in depressive symptoms; This measure ranges from 0-60; higher scores reflect (worse) higher levels of symptoms	Baseline, 10-week follow-up, and 14-week follow-up assessments
Secondary	SF-12 Health Survey	Measures change in physical-health related quality of life. Specifically, quantitative ratings of overall physical health functioning were rated on a Likert scale of 1-5 (1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor).	Baseline, 10-Week follow-up, and 14-Week follow-up Assessments
Secondary	Conflict Tactic Scales Revised	Measures change in overall number of different IPV acts over time (i.e., total count score). This measure ranges from 0-33; higher scores reflect higher levels of IPV (i.e., a worse outcome).	Baseline, 10-week follow-up, and 14-week follow-up assessments
Secondary	Physical, Mental and Social Service Care Use	Measures overall number of VA and non-VA health care visits (inclusive of physical, mental health, and social service use visits).	Baseline, 10-week follow-up, and 14-week follow-up assessments
Secondary	Client Services Questionnaire (CSQ-8)	Measures satisfaction with treatment; Scores range from 8 to 32; higher scores reflect higher satisfaction with treatment (i.e., a better outcome)	10-week follow-up assessment
Secondary	Patient Health Questionnaire	Measures change in somatic and physical health symptoms; score ranges from 0 to 30, with higher scores representing higher levels of physical health problems	Baseline, 10-week follow-up, and 14-week follow-up assessments
Secondary	Safety Behaviors Checklist	Measures the present use of safety behaviors participants are currently using to protect themselves. Each of the 15 items of this measure corresponds to a specific safety behavior. Participant indicates whether they have used each behavior using a dichotomous response option (yes = 1; no = 0). Scores are summed, with total scores ranging from 0-15. Higher scores indicate a higher number of safety behaviors enacted.	Baseline, 10-week follow-up, and 14-week follow-up assessments
Secondary	Connor-Davidson Resilience Scale	Measures patient resilience; Scores range from 0-100,with higher scores reflecting higher resilience	Baseline, 10-week follow-up, and 14-week follow-up assessments
Secondary	Depression Anxiety Stress Scale- Anxiety Subscale	Measures anxiety symptom severity; Scores range from 0-42, with higher scores indicating higher levels of anxiety.	Baseline, 10-week follow-up, and 14-week follow-up assessments
Secondary	Coping Strategies Inventory - Short Form	Measures engagement coping skills; Scores range from 8-40, with higher score reflecting better coping	Baseline, 10-week follow-up, and 14-week follow-up assessments
Secondary	Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.	Semi-structured qualitative interview questions developed for the purpose of this study to assess participants' perceptions of the acceptability, with a particular item to assess overall helpfulness of the intervention. Specifically, quantitative ratings of overall helpfulness were rated on a Likert scale of 1-5 (1=highly helpful, 2 = somewhat helpful, 3 = neither helpful nor unhelpful, 4 = somewhat unhelpful, 5=highly unhelpful).	Assessed at 10-week follow-up or 14-week follow-up, values at the end of 14 weeks reported