Testing STAR and TextSTAR: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Skills Training in Active Recovery (STAR) Video, Text Skills Training in Active Recovery (TextSTAR) program.
- Who it may be relevant to
- Registry conditions: Sexual Violence, Posttraumatic Stress Disorder (PTSD), Opioid Misuse. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Behavioral Skills Training in Active Recovery (STAR) Video
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 - Behavioral Text Skills Training in Active Recovery (TextSTAR) program
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
Primary outcome measures
- Opioid misuse [Time frame: 1 week]
- Change in acute stress/ posttraumatic stress [Time frame: 1 week, 1 month, 3 months, 6 months]
- Change in Tobacco, Alcohol, and Other Drug Use Frequency [Time frame: 1 week, 1 month, 3 months, 6 months]
- Substance use severity [Time frame: baseline, 1 month, 3 months, 6 months]
- Depression symptoms [Time frame: 1 month, 3 months, 6 months]
- Mindfulness skills usage [Time frame: 1 week, 1 month, 3 months, 6 months]
- Perceived control over recovery process [Time frame: 1 month, 3 months, 6 months]
- Pain severity [Time frame: baseline, 1 week, 1 month, 3 months, 6 months]
- Opioid craving [Time frame: baseline, 1 week, 1 month, 3 months, 6 months]
Secondary outcome measures (4)
- Sexual violence stigma [Time frame: 1 month, 3 months, 6 months]
- Emotion dysregulation [Time frame: 1 month, 3 months, 6 months]
- Social support [Time frame: 1 month, 3 months, 6 months]
- Self-compassion [Time frame: 1 month, 3 months, 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- University of Louisville Health — Louisville
- University of North Carolina — Chapel Hill
- University of Wisconsin — Madison
Identifiers
NCT: NCT07630428 · 2026-0198 · 4R33DA059897-03 · UWMSN | L&S | Psychology · FA · Protocol Version 6/11/2026