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临床试验/NCT02957747
NCT02957747已完成不适用

Addressing the Health Concerns of VA Women With Sexual Trauma

VISN 17 Center of Excellence3 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2017年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
153
试验地点
3
主要终点
Change in Number of Health Risks

研究概览

简要总结

Lifetime sexual trauma (ST) (i.e., behaviors that range from unwanted sexual touching to attempted or completed rape) is a significant social and public health problem among women Veterans. For women Veterans, lifetime ST can occur prior to, during or after military service. ST is associated with multiple difficulties and risks, including posttraumatic stress disorder (PTSD), intimate partner violence (IPV), and alcohol misuse. Providing an effective, integrated, and low-cost intervention that targets ST-related risks for women Veterans with lifetime ST would advance clinical care for these vulnerable women.

This research will develop and assess a computer-delivered intervention (Safety and Health Experiences Program; SHE) that will provide a screening and brief behavior intervention for women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD). SHE will be designed to provide individualized assessment, feedback, and referrals for women Veterans with any lifetime ST. SHE will take place within a primary care setting. Primary care visits are frequent points of health care contact for women Veterans making the visit itself the ideal, and possibly only, opportunity to provide behavioral interventions.

This study will lay the groundwork for a larger clinical trial of the SHE program in multiple VA primary care settings. If effective, the intervention, SHE, represents an innovative and low cost service for early identification and intervention that could be implemented nationwide with ease and speed to address the needs of women Veterans with lifetime ST. The long-term goal of the project is to make a significant impact on advancing health services research by introducing and testing a novel and potentially powerful service tool that may improve service delivery to address the co-occurring health concerns for women Veterans with any lifetime ST.

详细描述

The VA Women's Health Research Agenda underscores the importance of improving the safety and health outcomes of returning Veteran women. With greater numbers of women joining the military, the need for gender-specific VA-based interventions is increasingly important. Posttraumatic stress disorder (PTSD), intimate partner violence (IPV), and alcohol use are closely interrelated and significant concerns for women Veterans with a history of sexual trauma (ST). Given that screening for military sexual trauma (MST) is mandated within VAs, a computer delivered intervention has the potential to be easily integrated into the standard of care for women who screen positive for MST and/or other lifetime STs, increasing the identification of high-risk women Veterans. This intervention will provide a computer-based intervention on a VA issued laptop that could improve delivery service and fill a healthcare gap for a vulnerable Veteran population.

The long-term goal of the project is to make a significant impact on advancing health services research by introducing and testing a novel and potentially powerful service tool that may improve service delivery to address the co-occurring health concerns for VA women with lifetime ST. The intervention, Safe and Healthy Experiences (SHE), a brief modular, computer-based intervention, will target interrelated health risks for women Veterans with lifetime ST (i.e. alcohol misuse, IPV, and PTSD). SHE will provide individualized assessment, feedback, and referrals for women Veterans with lifetime ST. The intervention is based on motivational interviewing (MI), a well-defined intervention strategy that has yielded particularly promising results in a range of clinical issues, including interpersonal violence, and a range of patient populations, including male and female Veterans. MI is a collaborative and non-confrontational approach that emphasizes increasing a participant's awareness of successful steps towards well-being. MI is consistent with an empowerment model, which is a highly recommended intervention model for victimized women and both MI and an empowerment model converge on important principles for intervening with victimized women.

Findings from the study will provide the necessary groundwork to examine the efficacy of SHE in a future, large clinical trial. If the SHE intervention is found to be feasible, acceptable and efficacious in improving outcomes for women Veterans with lifetime ST, the ultimate goal would be for the program to be integrated into clinical care and widely disseminated. There are two phases of research directed toward these aims: 1) develop and refine an integrated screening and behavior intervention for VA women with lifetime ST in a brief modular computer-based format that can be administered in a VA primary care setting, and 2) collect data on the feasibility, acceptability, and initial efficacy of the intervention in improving the health of VA women, and increasing utilization of treatment and resources.

The study aims are to:

  1. Develop the preliminary computer-based intervention, incorporating information gained in informant interviews.
  2. Perform a small open trial (n = 20) of SHE to assess feasibility of recruitment of target population and acceptability of intervention and study procedures.
  3. Conduct an initial randomized control trial in a sample of 150 women Veterans who screen positive for lifetime sexual trauma (ST) and have at least one risk factor (i.e., screen positive for intimate partner violence (IPV), posttraumatic stress disorder (PTSD), and/or heavy drinking) to demonstrate the feasibility of SHE and the acceptability of SHE via participant report of ease of use, helpfulness, and overall satisfaction.
  4. Examine preliminary evidence for the hypotheses that, relative to the control condition, screening and referral only (SR), SHE will result in:

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female Veterans
  • Lifetime history of ST with at least one risk factor: heavy drinking within the past 3 months, screen positive for current PTSD or for IPV within last 12 months
  • Age 18-65
  • Seeking treatment through the Women's Primary Care Clinics at the Central Texas VA Healthcare System.
  • Ability to understand study procedures in English
  • Not actively in suicidal or homicidal crisis warranting imminent hospitalization

排除标准

  • 未提供

结局指标

主要结局

Change in Number of Health Risks

时间窗: Four months

Number of health risks calculated using scores exceeding threshold on CAS, PCL-5 or AUDIT (see secondary outcomes)

次要结局

  • Adapted Treatment Services Review(4 month)
  • The Client Satisfaction Questionnaire(time zero (completed immediately after participant receives intervention session))

研究者

发起方
VISN 17 Center of Excellence
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Suzannah Creech

Psychologist

VISN 17 Center of Excellence

研究点 (3)

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