Intimate Partner ViolenceRISENCT03261700
Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE)
A study testing RISE and Information and referral condition in people with Intimate Partner Violence and Self-efficacy, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intimate Partner Violence, Self-efficacy
- What is being tested?
- RISE and Information and referral condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2018to 23 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any violation of inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
About this study
Official title: Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE): Tailoring and Evaluating a Patient-Centered Counseling Intervention for Women Veterans
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.
Read the 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:
- 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).
- 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.
- 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).
- Conditions
- Intimate Partner Violence, Self-efficacy
- Being tested
- RISE, Information and referral condition
- Keywords
- women Veterans, interpersonal violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISEBehavioural
Also called Recovering from IPV through Strengths and Empowerment
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.
Information and referral conditionOther
Also called Control 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).
| Study group | Role | What they receive |
|---|---|---|
| RISE | Experimental | 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, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources. Receives: Behavioral: RISE |
| Information and referral condition | Active comparator | This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources. Receives: Other: Information and referral condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline,10-week follow-up, and 14-week follow-up assessments
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
Measured: Baseline, 10-week follow-up, and 14-week follow-up assessments
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)
Measured: Baseline, 10-week follow-up, and 14-week follow-up assessments
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.
Measured: Baseline, 10-week follow-up, and 14-week follow-up assessments
Secondary outcomes (12)
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.
Measured: Baseline, 10-week follow-up, and 14-week follow-up assessments
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
Measured: Baseline, 10-week follow-up, and 14-week follow-up assessments
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).
Measured: Baseline, 10-Week follow-up, and 14-Week follow-up Assessments
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).
Measured: Baseline, 10-week follow-up, and 14-week follow-up assessments
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).
Measured: Baseline, 10-week follow-up, and 14-week follow-up assessments
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)
Measured: 10-week follow-up assessment
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
Measured: Baseline, 10-week follow-up, and 14-week follow-up assessments
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.
Measured: Baseline, 10-week follow-up, and 14-week follow-up assessments
Connor-Davidson Resilience Scale
Measures patient resilience; Scores range from 0-100,with higher scores reflecting higher resilience
Measured: Baseline, 10-week follow-up, and 14-week follow-up assessments
Depression Anxiety Stress Scale- Anxiety Subscale
Measures anxiety symptom severity; Scores range from 0-42, with higher scores indicating higher levels of anxiety.
Measured: Baseline, 10-week follow-up, and 14-week follow-up assessments
Coping Strategies Inventory - Short Form
Measures engagement coping skills; Scores range from 8-40, with higher score reflecting better coping
Measured: Baseline, 10-week follow-up, and 14-week follow-up assessments
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).
Measured: Assessed at 10-week follow-up or 14-week follow-up, values at the end of 14 weeks reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start22 Oct 2018
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- For the RCT (Aim 3), participants will be randomized to RISE or an information and referral condition.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Boston Healthcare System
- Responsible party
- Sponsor
- Investigators
- Katherine M. Iverson, PhD MA BA, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261700
- Sponsor's protocol ID
- IIR 16-062
- Other IDs
- 1I01HX002178-01A1
- Acronym
- RISE
- Status last verified
- Jul 2023
- First submitted
- 17 Aug 2017
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29859496Grillo 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.
PubMed 30994401Iverson 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.
PubMed 31203176Danitz 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.
PubMed 31771557Iverson 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.
PubMed 34110870Iverson 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.
PubMed 34813687Shayani 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.
PubMed 35270204Davin 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.
PubMed 34735188Iverson 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.
PubMed 36042090Webermann 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.
PubMed 35099821Harper KL, Taverna E, Mahoney CT, Shipherd JC, Iverson KM. Comparing sexual minority and heterosexual women's intimate partner violence treatment outcomes: Secondary analysis of a randomized clinical trial. Psychol Serv. 2026 Mar 16:10.1037/ser0001033. doi: 10.1037/ser0001033. Online ahead of print.
PubMed 41843459
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE): Tailoring and Evaluating a Patient-Centered Counseling Intervention for Women Veterans
- ClinicalTrials.gov ID
- NCT03261700
- Acronym / sponsor ID
- RISE / IIR 16-062
- Conditions
- Intimate Partner Violence, Self-efficacy
- Keywords
- women Veterans, interpersonal violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Boston Healthcare System
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Posted 30 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- For the RCT (Aim 3), participants will be randomized to RISE or an information and referral condition.
| Arm | Type | Receives |
|---|---|---|
| RISE | Experimental | Behavioral: RISEThis 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, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources. |
| Information and referral condition | Active comparator | Other: Information and referral conditionThis brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Any violation of inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RISEAlso: Recovering from IPV through Strengths and EmpowermentThis 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. | Behavioural | RISE |
| Information and referral conditionAlso: Control conditionParticipants 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). | Other | Information and referral condition |
Primary outcome
Empowerment Via the Personal Progress Scale Revised
Time frame: Baseline,10-week follow-up, and 14-week follow-up assessments
Measures change in sense of personal empowerment; minimum value = 28 and maximum score = 196; higher scores indicate higher personal empowerment
Self-efficacy Via the General Self-Efficacy Scale
Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
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
Valued Living Questionnaire
Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
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)
Patient Activation Measure (PAM-13)
Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
Measures change in patient engagement in needed health care; scores are transferred to a theoretical 0-100 scale; higher scores indicate higher patient activation.
12 secondary outcomes
PTSD Checklist for DSM-5
Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
Center for Epidemiological Studies-Depression Scale
Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
SF-12 Health Survey
Time frame: Baseline, 10-Week follow-up, and 14-Week follow-up Assessments
Conflict Tactic Scales Revised
Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
Physical, Mental and Social Service Care Use
Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
Client Services Questionnaire (CSQ-8)
Time frame: 10-week follow-up assessment
Patient Health Questionnaire
Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
Safety Behaviors Checklist
Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
Connor-Davidson Resilience Scale
Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
Depression Anxiety Stress Scale- Anxiety Subscale
Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
Coping Strategies Inventory - Short Form
Time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.
Time frame: Assessed at 10-week follow-up or 14-week follow-up, values at the end of 14 weeks reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29859496Dardis 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.
- Background: PubMed 30994401Grillo 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.
- Background: PubMed 31203176Iverson 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.
- Background: PubMed 31771557Danitz 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.
- Background: PubMed 34110870Iverson 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.
- Results publication: PubMed 34813687Iverson 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.
- Results publication: PubMed 35270204Shayani 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.
- Results publication: PubMed 34735188Davin 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.
- Results publication: PubMed 36042090Iverson 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.
- Results publication: PubMed 35099821Webermann 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.
- Derived from this study: PubMed 41843459Harper KL, Taverna E, Mahoney CT, Shipherd JC, Iverson KM. Comparing sexual minority and heterosexual women's intimate partner violence treatment outcomes: Secondary analysis of a randomized clinical trial. Psychol Serv. 2026 Mar 16:10.1037/ser0001033. doi: 10.1037/ser0001033. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine M. Iverson, PhD MA BA principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RISE and Information and referral condition in people with Intimate Partner Violence and Self-efficacy, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Empowerment Via the Personal Progress Scale Revised (time frame: Baseline,10-week follow-up, and 14-week follow-up assessments). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03261700, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.