Clinical trial NCT06906302: RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
Official title: Recovering From IPV Through Strengths and Empowerment (RISE) Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intimate Partner Violence (IPV)
Keywords: RISE
Enhanced Care as Usual (ECAU)
Healthcare patients
Self-efficacy
Depression
Post-Traumatic Stress Disorders (PTSD)
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: VA Boston Healthcare System
name: VA Philadelphia Healthcare System
name: VA Minnesota Healthcare System
name: Patient-Centered Outcomes Research Institute
First posted: 2025-04-02
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Self-efficacy
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
measure: Post traumatic stress disorder (PTSD) symptoms
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
measure: Alcohol use
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
measure: Hopelessness
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
measure: Self-reported quality of life
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
measure: Valued living
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
measure: IPV
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
measure: Measure of Victim Empowerment Related to Safety
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
measure: Health care and social service use
timeFrame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
measure: VHA health care use
timeFrame: 12 months before baseline, 12 months after baseline
measure: Treatment satisfaction
timeFrame: 3 months
measure: Perceived Benefits/Harms
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
city: Minneapolis
country: United States
facility: VA Minneapolis Healthcare System
state: Minnesota
city: Philadelphia
country: United States
facility: VA Philadelphia Healthcare System
state: Pennsylvania
Study officials:
affiliation: V Boston Healthcare System, BU CASchool Medicine Psychiatry
name: Katherine M Iverson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Philadelphia Healthcare System
name: Melissa Dichter, PhD MSW
role: PRINCIPAL_INVESTIGATOR
References: