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

NCT ID: NCT06906302

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2030-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intimate Partner Violence (IPV)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

RISE

Intervention Type 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).

Advocacy-based ECAU (Enhanced Care as Usual)

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

Group Type ACTIVE_COMPARATOR

Advocacy-based ECAU

Intervention Type 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.

Interventions

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RISE

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).

Intervention Type BEHAVIORAL

Advocacy-based ECAU

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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, and
* 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
* untreated or unstable symptoms of mania or psychosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Boston Healthcare System

FED

Sponsor Role collaborator

VA Philadelphia Healthcare System

UNKNOWN

Sponsor Role collaborator

VA Minnesota Healthcare System

UNKNOWN

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine M Iverson, PhD

Role: PRINCIPAL_INVESTIGATOR

V Boston Healthcare System, BU CASchool Medicine Psychiatry

Melissa Dichter, PhD MSW

Role: PRINCIPAL_INVESTIGATOR

VA Philadelphia Healthcare System

Locations

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VA Boston Healthcare System

Boston, Massachusetts, United States

Site Status RECRUITING

VA Minneapolis Healthcare System

Minneapolis, Minnesota, United States

Site Status RECRUITING

VA Philadelphia Healthcare System

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katherine M Iverson, PhD

Role: CONTACT

857-364-2066

Julianne Brady

Role: CONTACT

Facility Contacts

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Katherine M Iverson, PhD

Role: primary

Princess Ackland, PhD

Role: primary

Melissa Dichter, PhD

Role: primary

Other Identifiers

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BPS-2023C2-33320

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-45215

Identifier Type: -

Identifier Source: org_study_id

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