Testing STAR and TextSTAR: A Randomized Controlled Trial
2026年7月6日 更新者：University of Wisconsin, Madison
The goal of this clinical trial is to learn whether a video given for recent sexual assault survivors and/or a 3-week text messaging intervention with similar content is effective at reducing mental health problems and substance misuse following the assault.
研究概览
地位
邀请报名
详细说明
This NIDA-funded HEAL Initiative: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence R33 seeks to test a brief video and text messaging intervention to deliver during Sexual Assault Medical Forensic Examiner (SAMFE) care to prevent the onset or escalation of PTSD and opioid misuse among survivors of sexual assault.
The investigators will test whether the video is associated with reductions in symptoms and whether for those above threshold on PTSD and opioid misuse symptoms at 1 week, the text message program is associated with reductions in symptoms at 1, 3, and 6 months post-assault.
研究类型
介入性
注册 (估计的)
394
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Kentucky
-
Louisville、Kentucky、美国、40202
- University of Louisville Health
-
-
North Carolina
-
Chapel Hill、North Carolina、美国、27599
- University of North Carolina
-
-
Wisconsin
-
Madison、Wisconsin、美国、53792
- University of Wisconsin
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 18 or older
- Can read and respond to questions in English
- Are receiving a SAMFE exam for a 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
Exclusion Criteria:
- Under age 18
- Those who cannot read and respond to questionnaires in English
- Those seeking care that does not include a SAMFE exam
- Those who cannot consent to receive SAMFE 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：视频、高于阈值、文本
处于这种情况的参与者将收到 STAR 干预视频，而 1 周内 PTSD 或阿片类药物滥用超过阈值的参与者将被随机分配接受 textSTAR 干预。
|
为期 3 周的每日短信计划，其中包括支持性/赋权信息以及简短的应对技巧，以避免避免安全但可怕的情况，应对痛苦和使用冲动，并寻求社会支持以帮助康复
a 17-minute video that includes psychoeducation about ptsd and substance misuse plus tips to not avoid safe but scary situations, cope with distress and urges to use, and engage with social support to aid recovery
|
|
实验性的：视频，高于阈值，无文本
处于这种情况的参与者将收到 STAR 干预视频，而 1 周内 PTSD 或阿片类药物滥用超过阈值的参与者将被随机分配不接受 textSTAR。
|
a 17-minute video that includes psychoeducation about ptsd and substance misuse plus tips to not avoid safe but scary situations, cope with distress and urges to use, and engage with social support to aid recovery
|
|
实验性的：视频，低于阈值
处于这种情况的参与者将收到 STAR 干预视频，并在 1 周时其 PTSD 和阿片类药物滥用低于阈值，并且不会被随机分配接受进一步干预。
|
a 17-minute video that includes psychoeducation about ptsd and substance misuse plus tips to not avoid safe but scary situations, cope with distress and urges to use, and engage with social support to aid recovery
|
|
实验性的：无视频、高于阈值、文本
处于这种情况的参与者将不会收到 STAR 干预视频，而 1 周内 PTSD 或阿片类药物滥用超过阈值的参与者将被随机分配接受 textSTAR 干预。
|
为期 3 周的每日短信计划，其中包括支持性/赋权信息以及简短的应对技巧，以避免避免安全但可怕的情况，应对痛苦和使用冲动，并寻求社会支持以帮助康复
|
|
无干预：无视频、高于阈值、无文本
处于这种情况的参与者将不会收到 STAR 干预视频，并且 1 周内 PTSD 或阿片类药物滥用超过阈值的参与者将不会被随机分配接受 textSTAR 干预。
|
|
|
无干预：无视频，低于阈值
处于这种情况的参与者将不会收到 STAR 干预视频，并且在 1 周时 PTSD 和阿片类药物滥用将低于阈值，并且不会被随机分配接受进一步干预。
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Opioid misuse
大体时间：1 week
|
Assessed using Tobacco, Alcohol, Prescription Medication, and Other Substance (TAPS) Tool-part 1. 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 on a scale from 0 = never to 4 = daily/almost daily. Any response other than "never" on the TAPS-1 indicates a positive screen, which is used in conjunction with the PCL-5 to determine responder status for randomization to the text program. |
1 week
|
|
Change in acute stress/ posttraumatic stress
大体时间：1 week, 1 month, 3 months, 6 months
|
Assessed with 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.
|
1 week, 1 month, 3 months, 6 months
|
|
Change in Tobacco, Alcohol, and Other Drug Use Frequency
大体时间：1 week, 1 month, 3 months, 6 months
|
Assessed using the Timeline Followback (TLFB) Method The Timeline Followback Method (TLFB) is a widely used tool for assessing substance use (alcohol, drugs, cigarettes) that requires individuals to retrospectively report daily use of each type of substance on a calendar.
For alcohol, participants are shown a standard drinks graphic and then asked to report how many drinks they consumed each day on a calendar and how many hours they drank on that day.
For other substances, they are asked to report how many times they used.
|
1 week, 1 month, 3 months, 6 months
|
|
Substance use severity
大体时间：baseline, 1 month, 3 months, 6 months
|
Assessed with Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; lifetime @ baseline).
The ASSIST is an 8-item questionnaire.
Item 1 maps lifetime use, while Items 2-8 measure frequency, dependence signs, and consequences of use.
Responses for questions 2 through 8 are scored as follows: Never = 0; Once or twice = 1 or 2; Monthly = 2 to 4; Weekly = 3 to 5; and, Daily or almost daily: 4. Scores range from 0-39, where higher scores indicate greater severity of use.
|
baseline, 1 month, 3 months, 6 months
|
|
Depression symptoms
大体时间：1 month, 3 months, 6 months
|
Assessed using the Patient Health Questionnaire-9 (PHQ-9) The PHQ-9 is an 9-item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems.
It is scored on a 4-point Likert scale where 0 = not at all to 3 = nearly every day.
The total possible range of scores is 0-27 where higher scores indicate more depressive symptoms.
|
1 month, 3 months, 6 months
|
|
Mindfulness skills usage
大体时间：1 week, 1 month, 3 months, 6 months
|
Assessed with 16 items from the Dialectical Behavior Therapy (DBT) skills subscale of the Ways of Coping Checklist, a 38 item self-report instrument that assesses DBT skills utilization in the past week on a scale from 0 = never used to 3 = used regularly.
The checklist has excellent psychometric properties and has been shown to discriminate patients who received skills training during treatment from those who did not.
Scores range from 0-48, where higher scores reflect greater skills utilization.
|
1 week, 1 month, 3 months, 6 months
|
|
Perceived control over recovery process
大体时间：1 month, 3 months, 6 months
|
Assessed with the 8-item Perceived Present Control subscale of the Perceived Control Over Stressful Events Scale.
Statements are rated on a Likert scale ranging from 1 (Very strongly disagree) to 4 (Very strongly agree), with a score range of 8-32, where higher averages indicate stronger perceived control.
The scale has excellent psychometric properties and higher scores (which reflect greater perceived control) have been associated with recovery following sexual violence.
|
1 month, 3 months, 6 months
|
|
Pain severity
大体时间：baseline, 1 week, 1 month, 3 months, 6 months
|
Assessed with the Brief Pain Inventory (BPI), a 4-item self-report measure that asks participants to rate their worst pain in the last week, their least pain in the last week, their pain on average, and their pain right now on a scale from 0 = no pain at all to 10 = pain as bad as you can imagine.
An overall pain severity score is computed by taking the mean of the four items.
|
baseline, 1 week, 1 month, 3 months, 6 months
|
|
Opioid craving
大体时间：baseline, 1 week, 1 month, 3 months, 6 months
|
Assessed with the 3-item Opioid Craving Scale which asks participants to rate how strong their desire to use opioids in the past 24-hours was (0 = no desire to use, 9 = extremely strong desire to use), how likely they would be to use if in the same environment when they used to use (0 = not at all likely, 9 = extremely likely), and how strong urges for opioids are when something reminds survivor of opioids (0 = no urge to use, 9 = extreme urge to use).
Items are averaged for a total score (ranging from 0-9).
Only those with any opioid use experience are asked these questions.
|
baseline, 1 week, 1 month, 3 months, 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sexual violence stigma
大体时间：1 month, 3 months, 6 months
|
Assessed via the 9-item Sexual Violence Related Stigma Scale which asks about individual, interpersonal, and societal aspects of stigma.
It is rated on a 4-point Likert scale, where 0= strongly disagree and 3= strongly agree.
Scores range from 0-27.
Higher total scores indicate a greater severity of sexual violence-related stigma experienced or internalized by the survivor.
|
1 month, 3 months, 6 months
|
|
Emotion dysregulation
大体时间：1 month, 3 months, 6 months
|
Assessed via the Difficulties in Emotion Regulation Scale - 16 item version (DERS-16), which asks about the frequency with which individuals experience difficulties in emotion regulation from 1 = not at all to 5 = almost always.
Items are summed so total scores range from 16-80, with higher scores indicating greater difficulties in emotion regulation.
|
1 month, 3 months, 6 months
|
|
Social support
大体时间：1 month, 3 months, 6 months
|
Assessed using the The Multidimensional Scale of Perceived Social Support (MSPSS).
MSPSS is a 12-item tool measuring support from family, friends, and significant others using a 7-point Likert scale (1=Very Strongly Disagree to 7=Very Strongly Agree).
Total scores range from 12 to 84, with higher scores indicating greater perceived support.
|
1 month, 3 months, 6 months
|
|
Self-compassion
大体时间：1 month, 3 months, 6 months
|
Assessed via 6 items from the Self Compassion Scale-Short Form (SCS-SF) that assess self-kindness, common humanity, and mindfulness on a scale from 1 = almost never to 5 = almost always.
Items are averaged so total scores range from 1-5 where higher scores show higher self compassion.
|
1 month, 3 months, 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kate Walsh, PhD、University of Wisconsin, Madison
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月25日
初级完成 (估计的)
2029年6月1日
研究完成 (估计的)
2029年12月1日
研究注册日期
首次提交
2026年6月1日
首先提交符合 QC 标准的
2026年6月1日
首次发布 (实际的)
2026年6月5日
研究记录更新
最后更新发布 (实际的)
2026年7月7日
上次提交的符合 QC 标准的更新
2026年7月6日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2026-0198
- FA (其他标识符：UW Madison)
- UWMSN | L&S | Psychology (其他标识符：UW Madison)
- 4R33DA059897-03 (美国 NIH 拨款/合同)
- Protocol Version 6/11/2026 (其他标识符：UW Madison)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.