Testing STAR and TextSTAR: A Randomized Controlled Trial
6. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Påmelding etter invitasjon
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
394
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- University of Louisville Health
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599
- University of North Carolina
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Wisconsin
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Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Video, over terskel, tekst
Deltakere i denne tilstanden vil motta STAR-intervensjonsvideoen, og de som er over terskel for PTSD eller opioidmisbruk etter 1 uke vil bli randomisert til å motta textSTAR-intervensjonen.
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et 3-ukers daglig tekstprogram som inkluderer støttende/styrkende meldinger sammen med korte mestringstips for ikke å unngå trygge, men skumle situasjoner, takle nød og trang til å bruke, og engasjere seg med sosial støtte for å hjelpe til med restitusjon
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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Eksperimentell: Video, over terskel, ingen tekst
Deltakere i denne tilstanden vil motta STAR-intervensjonsvideoen, og de som er over terskelverdien for PTSD eller misbruk av opioid etter 1 uke vil bli randomisert til ikke å motta textSTAR.
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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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Eksperimentell: Video, under terskel
Deltakere i denne tilstanden vil motta STAR-intervensjonsvideoen og vil være under terskelen for PTSD og misbruk av opioid etter 1 uke og vil ikke bli randomisert til å motta ytterligere intervensjon.
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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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Eksperimentell: Ingen video, over terskel, tekst
Deltakere i denne tilstanden vil ikke motta STAR-intervensjonsvideoen, og de som er over terskel for PTSD eller misbruk av opioid etter 1 uke vil bli randomisert til å motta textSTAR-intervensjonen.
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et 3-ukers daglig tekstprogram som inkluderer støttende/styrkende meldinger sammen med korte mestringstips for ikke å unngå trygge, men skumle situasjoner, takle nød og trang til å bruke, og engasjere seg med sosial støtte for å hjelpe til med restitusjon
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Ingen inngripen: Ingen video, over terskel, ingen tekst
Deltakere i denne tilstanden vil ikke motta STAR-intervensjonsvideoen, og de som er over terskel for PTSD eller misbruk av opioid etter 1 uke vil ikke bli randomisert til å motta textSTAR-intervensjonen.
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Ingen inngripen: Ingen video, under terskel
Deltakere i denne tilstanden vil ikke motta STAR-intervensjonsvideoen og vil være under terskelen for PTSD og misbruk av opioid etter 1 uke og vil ikke bli randomisert til å motta ytterligere intervensjon.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Opioid misuse
Tidsramme: 1 week
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Sexual violence stigma
Tidsramme: 1 month, 3 months, 6 months
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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
Tidsramme: 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
Tidsramme: 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.
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1 month, 3 months, 6 months
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Self-compassion
Tidsramme: 1 month, 3 months, 6 months
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kate Walsh, PhD, University of Wisconsin, Madison
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. juni 2026
Primær fullføring (Antatt)
1. juni 2029
Studiet fullført (Antatt)
1. desember 2029
Datoer for studieregistrering
Først innsendt
1. juni 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
5. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Traumer og stressorerelaterte lidelser
- Narkotikarelaterte lidelser
- Psykiske lidelser
- Stoffrelaterte lidelser
- Kjemisk-induserte lidelser
- Stresslidelser, traumatiske
- Opioidrelaterte lidelser
- Stresslidelser, posttraumatisk
- Teknologi, industri og landbruk
- Teknologi
- Tapeopptak
- Audiovisuelle hjelpemidler
- Utdanningsteknologi
- Fjernsyn
- Videobåndopptak
Andre studie-ID-numre
- 2026-0198
- FA (Annen identifikator: UW Madison)
- UWMSN | L&S | Psychology (Annen identifikator: UW Madison)
- 4R33DA059897-03 (U.S. NIH-stipend/kontrakt)
- Protocol Version 6/11/2026 (Annen identifikator: UW Madison)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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Nei
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