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).
NCT Number: NCT06906302
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
VA Boston Healthcare System, Boston, Massachusetts, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 ECAU is a single 60-minute trauma-informed counseling intervention that includes supportive education, validating and empathetic statements, safety planning, resource provision and referrals.
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.
Time frame: Baseline, 3 months, 6 months. 9 months, 12 months, 15 months
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
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
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
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
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
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
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
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
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: 12 months before baseline, 12 months after baseline
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: 3 months
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
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.
Contact information is provided by the study sponsor or research team.
Julianne Brady
CONTACT
Katherine M Iverson, PhD
CONTACT
Boston University
Other
Recovering From IPV Through Strengths and Empowerment (RISE) Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
Acronym: RISE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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