Testing STAR and TextSTAR: A Video and Text Messaging Intervention for Recent Sexual Violence Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Opioid Misuse
研究概览
简要总结
This NIDA-funded HEAL Initiative: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence R61 seeks to develop and test a brief video intervention to deliver during Sexual Assault Nurse Examiner (SANE) care and a brief text messaging intervention to deliver in the month after the assault to prevent the onset or escalation of PTSD and opioid misuse among survivors of sexual assault.
详细描述
This pilot trial is part of a larger R61/R33 to test the effectiveness of brief video and text messaging interventions on PTSD and opioid misuse among recent survivors of sexual assault presenting for medical care. In the R61 phase, researchers are working with a sexual assault advisory board to develop the video and text interventions. The research team is partnering with 5-6 Sexual Assault Nurse Examiner programs across the United States to recruit 50 participants. In this pilot trial, researchers aim to test the feasibility of recruitment strategies, acceptability of the interventions among survivors, and preliminary effectiveness of the interventions at addressing PTSD and opioid misuse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Are 18 or older
- •Can read and respond to questions in English
- •Are receiving a SANE exam for sexual assault victimization within the previous week (7 days)
- •Not currently or about to be hospitalized for severe injuries, suicidality, or psychosis
- •Not currently or about to be incarcerated
排除标准
- •Patients under age 18
- •Those who cannot read and respond to questionnaires in English
- •Those seeking care that does not include a SANE exam
- •Those who cannot consent to receive SANE care.
- •Those who are currently or about to be hospitalized for severe injuries, suicidality, or psychosis
- •Those who are currently or about to be incarcerated (e.g., suspects, those who have experienced sexual assault within a prison setting and are returning to that setting, etc)
结局指标
主要结局
Change in Opioid Misuse
时间窗: 1 week to 1 month
Assessed using Tobacco, Alcohol, Prescription Medication, and Other Substance (TAPS) Tool. The TAPS tool is a brief, two-part assessment of substance use and misuse. The TAPS-1 is a screener with 4 items assessing frequency of use of tobacco, alcohol, prescription medication, and illicit substances. Any response other than "never" on the TAPS-1 indicates a positive screen, which leads to administration of the TAPS-2. The TAPS-2 is a brief assessment including 3-4 yes/no questions for each class of substances assessing level of use, dependence, and concern from others. Cut-offs for problematic substance use and substance use disorder are based on scores on the TAPS-2.
Change in Posttraumatic Stress Disorder
时间窗: 1 week to 1 month
Assessed using PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Scores range from 0-80, with scores of 31 or higher indicating probable PTSD.
次要结局
- Mindfulness skills usage(1 week, 2 week, 3 week, 1 month)
- Perceived control over recovery process(1 month)
- Opioid craving(1 week, 2 week, 3 week, 1 month)
- Tobacco, Alcohol, and Other Drug Use(1 month)
- Drug use severity(1 month)
- Alcohol use severity(1 month)
- Opioid misuse severity(1 month)
- Depression level(1 month)
- Pain severity(1 week, 2 week, 3 week, 1 month)