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Recruiting NCT06906302

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

No phase Interventional Intimate Partner Violence (IPV)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RISE, Advocacy-based ECAU.
Who it may be relevant to
Registry conditions: Intimate Partner Violence (IPV). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Recovering From IPV Through Strengths and Empowerment (RISE) Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV

Overview

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.

Interventions

  • Behavioral 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).
  • 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.

Primary outcome measures

  • Self-efficacy [Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months]
Secondary outcome measures (12)
  • Depressive symptoms [Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months]
  • Post traumatic stress disorder (PTSD) symptoms [Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months]
  • Alcohol use [Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months]
  • Hopelessness [Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months]
  • Self-reported quality of life [Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months]
  • Valued living [Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months]
  • IPV [Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months]
  • Measure of Victim Empowerment Related to Safety [Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months]
  • Health care and social service use [Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months]
  • VHA health care use [Time frame: 12 months before baseline, 12 months after baseline]
  • Treatment satisfaction [Time frame: 3 months]
  • Perceived Benefits/Harms [Time frame: 3 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • VA Boston Healthcare System — Boston
  • VA Minneapolis Healthcare System — Minneapolis
  • VA Philadelphia Healthcare System — Philadelphia

Identifiers

NCT: NCT06906302 · H-45215 · BPS-2023C2-33320

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗