RISE for Domestic Violence

(RISE Trial)

Recruiting at 2 trial locations

Overseen By Julianne Brady

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: Cognitive impairment, Suicide intent, Mania, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

172 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Veterans Health Administration patients who have experienced intimate partner violence (IPV) in the past year. It will test two counseling approaches: RISE, which involves multiple sessions on topics like social support and health, and Advocacy-based ECAU, a single session focused on education and safety resources. The goal is to determine which method better improves self-confidence and overall health. Ideal candidates for this trial are veterans who have experienced physical, psychological, or sexual IPV and can consent to participate. As an unphased trial, this study provides veterans the chance to explore new counseling methods that could significantly enhance their well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that participants find the RISE program easy to handle. In past studies, individuals reported feeling more empowered and supported, with no major negative effects. RISE emphasizes building personal strengths and providing support, which improves mental health and safety without causing harm.

The Enhanced Care as Usual (ECAU) intervention has also successfully used similar supportive methods. Participants often feel safer and more informed, and no major safety issues have been reported with this type of intervention.

Both programs prioritize the well-being and empowerment of participants and are considered safe and helpful for those involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RISE treatment for domestic violence survivors because it focuses on empowerment and strengths, which is different from many standard approaches that might focus more on immediate safety or counseling alone. Unlike traditional care, which might involve a single session of advocacy-based support, RISE offers multiple sessions designed to help individuals build resilience and reclaim control over their lives. This ongoing, personalized support could lead to more sustainable recovery and empowerment for those affected by intimate partner violence.

What evidence suggests that this trial's treatments could be effective for improving self-efficacy and health in VHA patients experiencing IPV?

In this trial, participants will be randomized to receive either the RISE program or the Advocacy-based ECAU intervention. Previous studies have shown that the RISE program holds promise for veterans who have experienced intimate partner violence (IPV). It focuses on boosting self-confidence, helping participants feel more capable of managing their situations. Research indicates that RISE can improve mental health symptoms and increase the use of resources that support recovery. In contrast, the Enhanced Care as Usual (ECAU) intervention provides education on IPV, safety planning, and resource information in a single session. While both approaches aim to support recovery, RISE's multi-session format might offer more lasting benefits in building empowerment and resilience. ^{1 2 3 5 6}

Who Is on the Research Team?

Melissa Dichter, PhD MSW

Principal Investigator

VA Philadelphia Healthcare System

Katherine M Iverson, PhD

Principal Investigator

V Boston Healthcare System, BU CASchool Medicine Psychiatry

Are You a Good Fit for This Trial?

This trial is for Veterans Health Administration patients who have experienced intimate partner violence (IPV). Participants should be dealing with issues like PTSD, domestic violence, or depression. The study seeks individuals willing to undergo counseling and complete several health surveys over a period of about 15 months.

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

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

I have not treated or have unstable mania or psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the RISE intervention with up to 8 sessions or a single session of advocacy-based Enhanced Care as Usual (ECAU)

12 weeks

Up to 8 visits (in-person or virtual) for RISE, 1 visit for ECAU

Follow-up

Participants are monitored for self-efficacy and other health and safety indicators every three months for one year

12 months

4 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Advocacy-based ECAU
• RISE

Trial Overview The study compares two brief counseling interventions: RISE, which involves up to 8 sessions covering various topics related to IPV; and Advocacy-based ECAU, a single session focused on education about IPV, safety planning, and resource information. It aims to determine which method better improves self-efficacy and health outcomes.

How Is the Trial Designed?

Group I: RISE (Recovering from Intimate Partner Violence through Strengths and Empowerment) Experimental Treatment 1 Intervention

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

Group II: Advocacy-based ECAU (Enhanced Care as Usual) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

VA Minnesota Healthcare System

Collaborator

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

VA Boston Healthcare System

Collaborator

Trials

73

Recruited

971,000+

VA Philadelphia Healthcare System

Collaborator

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34110870/

Recovering from intimate partner violence through ... Recovering from intimate partner violence through Strengths and Empowerment (RISE): Development, pilot testing, and refinement of a patient- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03261700

Recovering From Intimate Partner Violence Through ... This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past ...

3. psychiatrist.com psychiatrist.com/jcp/rct-intervention-for-intimate-partner-violence-veterans/

Recovering From Intimate Partner Violence Through ... This RCT focused on a psychosocial counseling intervention for women experiencing intimate partner violence (IPV). Outcomes such as ...

4. mdpi.com mdpi.com/1660-4601/19/14/8793

Initial Evaluation of the Clinical Effects of RISE ... This reflects the fact that a notable proportion of Veterans report histories of sexual violence (i.e., child sexual abuse, unwanted sexual experiences during ...

5. psycnet.apa.org psycnet.apa.org/record/2021-53476-001

Recovering from intimate partner violence through ... Recovering from intimate partner violence through Strengths and Empowerment (RISE): ... efficacy; veterans; motivational interviewing; partner abuse. Index ...

6. va.gov va.gov/lovell-federal-health-care-va/programs/intimate-partner-violence-support/

Intimate Partner Violence Support | Lovell Federal Health ... The SAH Couples program assists in enhancing relationships and preventing problems from escalating to violence and abuse. It is a 10-week course ...