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.
調査の概要
状態
招待による登録
詳細な説明
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.
研究の種類
介入
入学 (推定)
394
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Kentucky
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Louisville、Kentucky、アメリカ、40202
- University of Louisville Health
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27599
- University of North Carolina
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
- University of Wisconsin
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：ビデオ、しきい値以上、テキスト
この状態の参加者はSTAR介入ビデオを受け取り、1週間の時点でPTSDまたはオピオイド誤用の閾値を超えている参加者はテキストSTAR介入を受けるように無作為に割り当てられます。
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3週間の毎日のテキストプログラム。安全ではあるが恐ろしい状況を避けず、苦痛や衝動に対処し、回復を助ける社会的サポートに参加するための簡単な対処法とともに、支援/力を与えるメッセージが含まれています。
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
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実験的：ビデオ、しきい値を超えています、テキストなし
この状態の参加者は STAR 介入ビデオを受け取り、1 週間の時点で PTSD またはオピオイド誤用の閾値を超えている参加者は、textSTAR を受けられないように無作為に割り当てられます。
|
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
|
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実験的：ビデオ、しきい値未満
この状態の参加者はSTAR介入ビデオを受け取り、1週間の時点でPTSDおよびオピオイド誤用の閾値を下回っており、さらなる介入を受けるためにランダム化されません。
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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
|
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実験的：ビデオなし、しきい値を超えています、テキストあり
この状態の参加者はSTAR介入ビデオを受けられず、1週間の時点でPTSDまたはオピオイド誤用の閾値を超えている参加者はテキストSTAR介入を受けるように無作為に割り当てられます。
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3週間の毎日のテキストプログラム。安全ではあるが恐ろしい状況を避けず、苦痛や衝動に対処し、回復を助ける社会的サポートに参加するための簡単な対処法とともに、支援/力を与えるメッセージが含まれています。
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介入なし：ビデオなし、しきい値を超えている、テキストなし
この状態の参加者は STAR 介入ビデオを受けられず、1 週間の時点で PTSD またはオピオイド誤用の閾値を超えている参加者は textSTAR 介入を受けるようにランダム化されません。
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介入なし：ビデオなし、しきい値を下回っています
この状態の参加者はSTAR介入ビデオを受けられず、1週間の時点でPTSDおよびオピオイド誤用の閾値を下回っており、さらなる介入を受けるためにランダム化されません。
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Opioid misuse
時間枠：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
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Change in acute stress/ posttraumatic stress
時間枠：1 week, 1 month, 3 months, 6 months
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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.
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1 week, 1 month, 3 months, 6 months
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Change in Tobacco, Alcohol, and Other Drug Use Frequency
時間枠：1 week, 1 month, 3 months, 6 months
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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.
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1 week, 1 month, 3 months, 6 months
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Substance use severity
時間枠：baseline, 1 month, 3 months, 6 months
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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.
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baseline, 1 month, 3 months, 6 months
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Depression symptoms
時間枠：1 month, 3 months, 6 months
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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.
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1 month, 3 months, 6 months
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Mindfulness skills usage
時間枠：1 week, 1 month, 3 months, 6 months
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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.
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1 week, 1 month, 3 months, 6 months
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Perceived control over recovery process
時間枠：1 month, 3 months, 6 months
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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.
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1 month, 3 months, 6 months
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Pain severity
時間枠：baseline, 1 week, 1 month, 3 months, 6 months
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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.
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baseline, 1 week, 1 month, 3 months, 6 months
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Opioid craving
時間枠：baseline, 1 week, 1 month, 3 months, 6 months
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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.
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baseline, 1 week, 1 month, 3 months, 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sexual violence stigma
時間枠：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.
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1 month, 3 months, 6 months
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Emotion dysregulation
時間枠：1 month, 3 months, 6 months
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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.
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1 month, 3 months, 6 months
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Social support
時間枠：1 month, 3 months, 6 months
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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
|
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Self-compassion
時間枠：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.
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1 month, 3 months, 6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Kate Walsh, PhD、University of Wisconsin, Madison
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月25日
一次修了 (推定)
2029年6月1日
研究の完了 (推定)
2029年12月1日
試験登録日
最初に提出
2026年6月1日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月7日
QC基準を満たした最後の更新が送信されました
2026年7月6日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-0198
- FA (その他の識別子：UW Madison)
- UWMSN | L&S | Psychology (その他の識別子：UW Madison)
- 4R33DA059897-03 (米国 NIH グラント/契約)
- Protocol Version 6/11/2026 (その他の識別子：UW Madison)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。