Intimate Partner Violence (IPV)RISENCT06906302
RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
A study testing RISE and Advocacy-based ECAU in people with Intimate Partner Violence (IPV), run by Boston University at 3 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intimate Partner Violence (IPV)
- What is being tested?
- RISE and Advocacy-based ECAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Sep 2025to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe cognitive impairment,
- suicide or homicide intent with a specific plan
- untreated or unstable symptoms of mania or psychosis
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Julianne Brady contact
United States3 sites, 3 recruiting
- Recruiting
VA Boston Healthcare System
Boston, Massachusetts, 02130
Katherine M Iverson, PhD
- Recruiting
VA Minneapolis Healthcare System
Minneapolis, Minnesota, 55417
Princess Ackland, PhD
- Recruiting
VA Philadelphia Healthcare System
Philadelphia, Pennsylvania, 19104
Melissa Dichter, PhD
About this study
Official title: Recovering From IPV Through Strengths and Empowerment (RISE) Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
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)
- Being tested
- RISE, Advocacy-based ECAU
- Keywords
- RISE, Enhanced Care as Usual (ECAU), Healthcare patients, Self-efficacy, Depression, Post-Traumatic Stress Disorders (PTSD)
- Medical subject headings
- Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISEBehavioural
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 ECAUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| RISE (Recovering from Intimate Partner Violence through Strengths and Empowerment) | Experimental | Participants randomized to the RISE arm will have 1 or more RISE sessions. Receives: Behavioral: RISE |
| Advocacy-based ECAU (Enhanced Care as Usual) | Active comparator | Participants randomized to this arm will have a single Advocacy-based ECAU session Receives: Behavioral: Advocacy-based ECAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
Secondary outcomes (12)
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.
Measured: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
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.
Measured: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
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.
Measured: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
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.
Measured: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
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.
Measured: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
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.
Measured: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
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.
Measured: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
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.
Measured: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
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.
Measured: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
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.
Measured: 12 months before baseline, 12 months after baseline
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start15 Sep 2025
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate Partner Violence (IPV)Studies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Boston Healthcare System, VA Philadelphia Healthcare System, VA Minnesota Healthcare System, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Katherine M Iverson, PhD, Principal investigator, V Boston Healthcare System, BU CASchool Medicine PsychiatryMelissa Dichter, PhD MSW, Principal investigator, VA Philadelphia Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906302
- Sponsor's protocol ID
- H-45215
- Other IDs
- BPS-2023C2-33320
- Acronym
- RISE
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovering From IPV Through Strengths and Empowerment (RISE) Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
- ClinicalTrials.gov ID
- NCT06906302
- Acronym / sponsor ID
- RISE / H-45215
- Conditions
- Intimate Partner Violence (IPV)
- Keywords
- RISE, Enhanced Care as Usual (ECAU), Healthcare patients, Self-efficacy, Depression, Post-Traumatic Stress Disorders (PTSD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- VA Boston Healthcare System, VA Philadelphia Healthcare System, VA Minnesota Healthcare System, Patient-Centered Outcomes Research Institute
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RISE (Recovering from Intimate Partner Violence through Strengths and Empowerment) | Experimental | Behavioral: RISEParticipants randomized to the RISE arm will have 1 or more RISE sessions. |
| Advocacy-based ECAU (Enhanced Care as Usual) | Active comparator | Behavioral: Advocacy-based ECAUParticipants randomized to this arm will have a single Advocacy-based ECAU session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- severe cognitive impairment,
- suicide or homicide intent with a specific plan
- untreated or unstable symptoms of mania or psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RISERISE 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). | Behavioural | RISE (Recovering from Intimate Partner Violence through Strengths and Empowerment) |
| Advocacy-based ECAUAdvocacy-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. | Behavioural | Advocacy-based ECAU (Enhanced Care as Usual) |
Primary outcome
Self-efficacy
Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julianne Brady contact
Katherine M Iverson, PhD principal investigator
V Boston Healthcare System, BU CASchool Medicine Psychiatry
Melissa Dichter, PhD MSW principal investigator
VA Philadelphia Healthcare System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RISE and Advocacy-based ECAU in people with Intimate Partner Violence (IPV), run by Boston University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine M Iverson, PhD (857-364-2066, Katherine.Iverson@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy (time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.