RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV

NCT06906302 | Recruiting

• 2 other identifiers: H-45215BPS-2023C2-33320
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Intimate Partner Violence (IPV)

Keywords

RISE; Enhanced Care as Usual (ECAU); Healthcare patients; Self-efficacy; Depression; Post-Traumatic Stress Disorders (PTSD)

Outcome Measures

Primary Outcomes (1)

• Self-efficacy

  Self-efficacy will be assessed with the General Self-Efficacy Scale (GSES), a 10-item instrument with possible responses for each item from 1 to 4 where 1= Not at all true, 2= Hardly true, 3= Moderately true, and 4=Exactly true.Scores can range from 10 to 40 and higher scores indicate more self efficacy.

  Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

Secondary Outcomes (12)

• Depressive symptoms

  Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

• Post traumatic stress disorder (PTSD) symptoms

  Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

• Alcohol use

  Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

• Hopelessness

  Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

• Self-reported quality of life

  Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

Study Arms (2)

RISE (Recovering from Intimate Partner Violence through Strengths and Empowerment)

EXPERIMENTAL

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

Behavioral: RISE

Advocacy-based ECAU (Enhanced Care as Usual)

ACTIVE COMPARATOR

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

Behavioral: Advocacy-based ECAU

Interventions

RISE BEHAVIORAL

RISE is personalized, trauma-informed, empowerment-oriented and variable-length, consisting of an initial 60-minute session and up to 7 additional 45-minute sessions (1-8 sessions total).

RISE (Recovering from Intimate Partner Violence through Strengths and Empowerment)

Advocacy-based ECAU BEHAVIORAL

Advocacy-based ECAU is a single 60-minute trauma-informed counseling intervention that includes supportive education, validating and empathetic statements, safety planning, resource provision and referrals.

Advocacy-based ECAU (Enhanced Care as Usual)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, and
• be able to provide informed consent including permission to have intervention sessions recorded

You may not qualify if:

• severe cognitive impairment,
• suicide or homicide intent with a specific plan
• untreated or unstable symptoms of mania or psychosis

Sponsors & Collaborators

• Boston University: lead
• VA Boston Healthcare System: collaborator
• VA Philadelphia Healthcare System: collaborator
• VA Minnesota Healthcare System: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

RECRUITING

VA Minneapolis Healthcare System

Minneapolis, Minnesota, 55417, United States

RECRUITING

VA Philadelphia Healthcare System

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Katherine M Iverson, PhD

  V Boston Healthcare System, BU CASchool Medicine Psychiatry

  PRINCIPAL INVESTIGATOR

• Melissa Dichter, PhD MSW

  VA Philadelphia Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine M Iverson, PhD

CONTACT

857-364-2066; Katherine.Iverson@va.gov

Julianne Brady

CONTACT

Julianne.Brady@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 2, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)