Testing STAR and TextSTAR: A Randomized Controlled Trial

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07630428
Status
Not Yet Recruiting

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Conditions

  • Opioid Misuse
  • Posttraumatic Stress Disorder (PTSD)
  • Sexual Violence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Skills Training in Active Recovery (STAR) Video — BEHAVIORAL
    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
  • Text Skills Training in Active Recovery (TextSTAR) program — BEHAVIORAL
    a 3-week daily text program that includes supportive/empowering messages along with brief coping tips to not avoid safe but scary situations, cope with distress and urges to use, and engage with social support to aid recovery

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
394 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Video, Above Threshold, Text
    Participants in this condition will receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will be randomized to receive the textSTAR intervention.
  • Experimental: Video, Above Threshold, No Text
    Participants in this condition will receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will be randomized to not receive textSTAR.
  • Experimental: Video, Below Threshold
    Participants in this condition will receive the STAR intervention video and will be below threshold on PTSD and opioid misuse at 1 week and will not be randomized to receive further intervention.
  • Experimental: No Video, Above Threshold, Text
    Participants in this condition will not receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will be randomized to receive the textSTAR intervention.
  • No Intervention: No Video, Above Threshold, No Text
    Participants in this condition will not receive the STAR intervention video and those who are above threshold on PTSD or opioid misuse at 1 week will not be randomized to receive the textSTAR intervention.
  • No Intervention: No Video, Below Threshold
    Participants in this condition will not receive the STAR intervention video and will be below threshold on PTSD and opioid misuse at 1 week and will not be randomized to receive further intervention.

Primary Outcome Measure

Opioid misuse [ Time Frame: 1 week ]

Central Contacts

Locations (3)

FacilityCityStateZIP
University of Louisville HealthLouisvilleKentucky40202
University of North CarolinaChapel HillNorth Carolina27599
University of WisconsinMadisonWisconsin53792

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By research site
University of Louisville Health· Louisville, KYUniversity of North Carolina· Chapel Hill, NCUniversity of Wisconsin· Madison, WI

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