RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
ConditionIntimate Partner Violence (IPV)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
severe cognitive impairment,
suicide or homicide intent with a specific plan
untreated or unstable symptoms of mania or psychosis
Trial design
Design model
Parallel
Treatments tested in this trial
RISE
BehavioralRISE 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 ECAU
BehavioralAdvocacy-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.
Treatment groups
172 Participants
are divided into 2 treatment groupsGroup A: RISE (Recovering from Intimate Partner Violence through Strengths and Empowerment)Experimental treatment 1 intervention
Group B: Advocacy-based ECAU (Enhanced Care as Usual)Active comparator 1 intervention
Trial outcomes
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 monthsSecondary 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 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston University
Lead sponsor
VA Boston Healthcare System
Collaborator
VA Philadelphia Healthcare System
Collaborator
VA Minnesota Healthcare System
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov