CClinicalTrials.gg
RecruitingNCT06906302RISEUpdated Sep 30, 2026

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

An interventional study of RISE and Advocacy-based ECAU in Intimate Partner Violence (IPV), sponsored by Boston University. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Boston University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
172
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Intimate Partner Violence (IPV)

Keywords

  • RISE
  • Enhanced Care as Usual (ECAU)
  • Healthcare patients
  • Self-efficacy
  • Depression
  • Post-Traumatic Stress Disorders (PTSD)
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • severe cognitive impairment,
  • suicide or homicide intent with a specific plan
  • untreated or unstable symptoms of mania or psychosis
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
172 participants (estimated)

Study arms

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

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

    Behavioral: RISE

  • Active comparator
    Advocacy-based ECAU (Enhanced Care as Usual)

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

    Behavioral: Advocacy-based ECAU

Interventions

  • BehavioralRISE

    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).

  • BehavioralAdvocacy-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.

05

What researchers measure

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.

    Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

Secondary outcomes

  1. Depressive symptoms

    Depressive symptoms will be assessed with the Center for Epidemiologic Studies Depression Scale (CESD), a 20-item instrument with possible responses for each item from 0 to 3 where 0= Rarely or none of the time (less than 1 day), 1= Some or a little of the time (1-2 days), 2= Occasionally or a moderate amount of the time (3-4 days), and 3= Most or all of the time (5-7 days). Possible range of scores is 0 to 60, with the higher scores indicating more depressive symptoms.

    Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

  2. Post traumatic stress disorder (PTSD) symptoms

    PTSD symptoms will be assessed with the PTSD Checklist -DSM-5, a 20-item self-report measure of the DSM-5 symptoms of PTSD. A 5-point Likert scale is used for each item from 0 = "Not at all" to 4 = "Extremely". Total possible scores can range from 0 to 80 with higher scores indicating more PTSD symptoms.

    Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

  3. Alcohol use

    Alcohol use will be assessed with the Alcohol Use Disorders Identification Test-10 (AUDIT-10), a 10-item instrument with possible responses for each item from 0 to 4 for questions 1-8 and possible responses of 0, 2, and 4 for questions 9 and 10. Total possible scores can range from 0 to 40 with higher scores indicating greater alcohol use.

    Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

  4. Hopelessness

    Hopelessness will be assessed by the 20-item Beck Hopelessness Scale (BHS). The BHS is scored by adding up the responses to 20 true-false questions. The possible score range is 0-20, with higher scores indicating greater hopelessness.

    Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

  5. Self-reported quality of life

    Quality of life will be assessed by World Health Organization - Quality of Life, Brief WHOQOL-BREF instrument, a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale with higher scores indicating a better quality of life.

    Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

  6. Valued living

    Valued living will be assessed with the Valued Living Questionnaire (VLQ) focusing on 10 valued domains of living which include (1) family, (2) marriage/couples, intimate relations, (3) parenting, (4) friendship, (5) work, (6) education, (7) recreation, (8) spirituality, (9) citizenship, and (10) physical self-care. Each domain is rated on a scale of 1-10, based on the level of importance to the respondent and the extent to which they have lived consistent with their values in the past week. A total score is calculated by multiplying the importance and consistency ratings for each domain, and then averaging those scores. Total scores range from 10 to 100 with higher scores indicating greater alignment with one's values.

    Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

  7. IPV

    Experiences of IPV from past or a current intimate partner will be measured using subscales of the Revised Conflict Tactics Scale (CTS-2). The physical aggression (12 items), psychological aggression (8 items), and sexual coercion (7 items) subscales include 27 items regarding the frequency of different IPV experiences (0=this has never happened, 1=1 time, 2=2 times, 3=3-5 times, 4=6-10 times, 5=11-20 times, and 6=20+ times). Items are summed for a total frequency score. Additionally, the number of different IPV behaviors experienced can be tallied to reflect a indicate the number of different IPV behaviors experienced. Higher scores reflect greater levels of IPV experience.

    Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

  8. Measure of Victim Empowerment Related to Safety

    Safety-related Empowerment will be measured with the Measure of Victim Empowerment Related to Safety (MOVERS), a 13- item measure that consists of three subscales: internal resources (6 items), expectations of support (4 items), and trade-offs (3 items), with response options on a scale from 1-5, with 1 being "never true" and 5 being "always true" for each internal resource and expectation of support subscale question. Responses options for the trade-off subscale are reverse scored with 1 = Always true and 5= Never true. Total possible scores can range from 13 to 65, with higher scores indicating higher levels of empowerment.

    Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

  9. Health care and social service use

    Items adapted from the National Survey of Veterans and prior studies examining health and social service use among individuals experiencing IPV, particularly in terms of VA and non-VHA psychosocial health services (e.g., mental health, housing, domestic violence agencies). The number and types of psychosocial treatment services will be examined.

    Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months

  10. VHA health care use

    VHA health care use will be extracted from the electronic medical records. The types and number of services used, particularly psychosocial health services, will be examined.

    Time frame: 12 months before baseline, 12 months after baseline

  11. Treatment satisfaction

    Treatment satisfaction will be assessed using the 8-item Client Satisfaction Questionnaire-8 (CSQ-8). Possible scores range from 8 to 32, with higher values indicating higher treatment satisfaction.

    Time frame: 3 months

  12. Perceived Benefits/Harms

    Perceived benefits/harms from participating in the interventions will be measured using 6 items adapted from prior studies. Possible responses on a Likert scale range from 1= strongly disagree to 5 = strongly agree, with item 4 reverse scored. Individual item scores and total scores will be examined.

    Time frame: 3 months

06

Study locations

3 of 3 sites recruiting
  • VA Boston Healthcare System
    Boston, Massachusetts 02130, United States
    • Katherine M Iverson, PhD · Contact
    Recruiting
  • VA Minneapolis Healthcare System
    Minneapolis, Minnesota 55417, United States
    • Princess Ackland, PhD · Contact
    Recruiting
  • VA Philadelphia Healthcare System
    Philadelphia, Pennsylvania 19104, United States
    • Melissa Dichter, PhD · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06906302
Lead sponsor
Boston University
Collaborators
VA Boston Healthcare System, VA Philadelphia Healthcare System, VA Minnesota Healthcare System, Patient-Centered Outcomes Research Institute
Responsible party
Sponsor
First posted
Apr 2, 2025
Start date
Sep 15, 2025
Primary completion
Jan 2030 (estimated)
Completion
Jan 2030 (estimated)
Last update
Sep 30, 2026

Study contacts

Katherine M Iverson, PhD
Contact
Katherine.Iverson@va.gov
857-364-2066
Julianne Brady
Contact
Julianne.Brady@va.gov
Katherine M Iverson, PhD
principal investigator · V Boston Healthcare System, BU CASchool Medicine Psychiatry
Melissa Dichter, PhD MSW
principal investigator · VA Philadelphia Healthcare System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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