RISE for Domestic Violence

(RISE Trial)

Recruiting at 2 trial locations

Overseen By Julianne Brady

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: Cognitive impairment, Suicide intent, Mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

172 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to improve treatment for Veterans Health Administration (VHA) patients who experience intimate partner violence (IPV). This study will evaluate two brief counseling interventions for VHA patients who have experienced IPV in the past 12 months: Recovering from IPV through Strength and Empowerment (RISE) and advocacy-based Enhanced Care as Usual (ECAU). The RISE intervention includes up to 8 sessions and includes specific topic areas (e.g., social support, health effects, resources). The other intervention, ECAU, includes a single session that includes supportive education about IPV and health effects, discussion of ways to increase safety, and information about resources. This study will test which approach is better for improving self-efficacy and other aspects of health. Participants will answer surveys about their self-efficacy and other health and safety indicators (e.g., mental health symptoms) right before receiving treatment, approximately 12 weeks later, and then every three months after that for one year. Participation in this research will last about 15 months.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Advocacy-based ECAU, RISE for Domestic Violence?

The research highlights the importance of advocacy in healthcare settings, showing that when patients and families are empowered to raise concerns, it can improve safety and outcomes. This suggests that advocacy-based treatments like RISE could be effective in supporting individuals experiencing domestic violence by empowering them to voice their needs and concerns. ^{1 2 3 4 5}

How is the RISE treatment for domestic violence different from other treatments?

RISE is unique because it is a brief, flexible counseling program tailored to each woman's needs, focusing on empowerment and strengths to help them recover from intimate partner violence. Unlike standard treatments, it can vary in length from 1 to 6 sessions and is designed to be highly individualized. ^{6 7 8 9 10}

Research Team

Katherine M Iverson, PhD

Principal Investigator

V Boston Healthcare System, BU CASchool Medicine Psychiatry

Melissa Dichter, PhD MSW

Principal Investigator

VA Philadelphia Healthcare System

Eligibility Criteria

This trial is for Veterans Health Administration patients who have experienced intimate partner violence (IPV). Participants should be dealing with issues like PTSD, domestic violence, or depression. The study seeks individuals willing to undergo counseling and complete several health surveys over a period of about 15 months.

Inclusion Criteria

Patients receiving care at an enrolled site/affiliated Community-Based Outpatient Clinic (CBOC)

Report experience of past-year physical, psychological, and/or sexual IPV on an established screening tool used to detect IPV in VHA

Be able to provide informed consent including permission to have intervention sessions recorded

Exclusion Criteria

Severe cognitive impairment

Suicide or homicide intent with a specific plan

I have not treated or have unstable mania or psychosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the RISE intervention with up to 8 sessions or a single session of advocacy-based Enhanced Care as Usual (ECAU)

12 weeks

Up to 8 visits (in-person or virtual) for RISE, 1 visit for ECAU

Follow-up

Participants are monitored for self-efficacy and other health and safety indicators every three months for one year

12 months

4 visits (virtual or in-person)

Treatment Details

Interventions

• Advocacy-based ECAU
• RISE

Trial Overview The study compares two brief counseling interventions: RISE, which involves up to 8 sessions covering various topics related to IPV; and Advocacy-based ECAU, a single session focused on education about IPV, safety planning, and resource information. It aims to determine which method better improves self-efficacy and health outcomes.

Participant Groups

Group I: RISE (Recovering from Intimate Partner Violence through Strengths and Empowerment) Experimental Treatment 1 Intervention

Participants randomized to the RISE arm will have 1 or more RISE sessions.

Group II: Advocacy-based ECAU (Enhanced Care as Usual) Active Control 1 Intervention

Participants randomized to this arm will have a single Advocacy-based ECAU session

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

VA Minnesota Healthcare System

Collaborator

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

VA Boston Healthcare System

Collaborator

Trials

73

Recruited

971,000+

VA Philadelphia Healthcare System

Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Into the night: factors affecting response to abnormal Early Warning Scores out-of-hours and implications for service improvement. [2014]

2. Brazil pubmed.ncbi.nlm.nih.gov

Patient advocacy actions by intensivist nurses. [2022]

3. England pubmed.ncbi.nlm.nih.gov

When patients (and families) raise the alarm: Patient and family activated rapid response as a safety strategy for hospitals. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The nurse advocate and care for the caregivers. [2004]

5. Brazil pubmed.ncbi.nlm.nih.gov

[Nursing Actions in practicing inpatient advocacy in a Burn Unit]. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Recovering From Intimate Partner Violence Through Strengths and Empowerment: Findings From a Randomized Clinical Trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of the Effectiveness of Advocacy Interventions for Adult Victims of Domestic Violence Within an Emergency Department Setting. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of an emergency department-based advocacy program for battered women on community resource utilization. [2019]

9. England pubmed.ncbi.nlm.nih.gov

A qualitative exploration of 'thrivership' among women who have experienced domestic violence and abuse: Development of a new model. [2020]

10. England pubmed.ncbi.nlm.nih.gov

The silent victims of domestic violence--who will speak? [2019]