跳至主要内容
临床试验/NCT06906302
NCT06906302招募中不适用

Recovering From IPV Through Strengths and Empowerment (RISE) Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV

Boston University5 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2025年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
172
试验地点
5
主要终点
Self-efficacy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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

Experimental

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

干预措施: RISE (Behavioral)

Advocacy-based ECAU (Enhanced Care as Usual)

Active Comparator

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

干预措施: Advocacy-based ECAU (Behavioral)

结局指标

主要结局

Self-efficacy

时间窗: 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.

次要结局

  • Depressive symptoms(Baseline, 3 months, 6 months. 9 months, 12 months, 15 months)
  • Post traumatic stress disorder (PTSD) symptoms(Baseline, 3 months, 6 months. 9 months, 12 months, 15 months)
  • Alcohol use(Baseline, 3 months, 6 months. 9 months, 12 months, 15 months)
  • Hopelessness(Baseline, 3 months, 6 months. 9 months, 12 months, 15 months)
  • Self-reported quality of life(Baseline, 3 months, 6 months. 9 months, 12 months, 15 months)
  • Valued living(Baseline, 3 months, 6 months. 9 months, 12 months, 15 months)
  • IPV(Baseline, 3 months, 6 months. 9 months, 12 months, 15 months)
  • Measure of Victim Empowerment Related to Safety(Baseline, 3 months, 6 months. 9 months, 12 months, 15 months)
  • Health care and social service use(Baseline, 3 months, 6 months. 9 months, 12 months, 15 months)
  • VHA health care use(12 months before baseline, 12 months after baseline)
  • Treatment satisfaction(3 months)
  • Perceived Benefits/Harms(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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