Testing STAR and TextSTAR: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sexual Violence; Opioid Misuse; Posttraumatic Stress Disorder (PTSD)
• Intervention / Treatment: Behavioral: Text Skills Training in Active Recovery (TextSTAR) program; Behavioral: Skills Training in Active Recovery (STAR) Video

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.

• Study Type: Interventional
• Enrollment (Estimated): 394
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kate Walsh, PhD; Phone Number: 608-262-8992; Email: klwalsh2@wisc.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Health
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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; 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
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.	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
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.	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
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.	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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid misuse	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	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	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	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	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	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	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual violence stigma	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	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	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	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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Kate Walsh, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Stress Disorders, Traumatic; Opioid-Related Disorders; Stress Disorders, Post-Traumatic; Technology, Industry, and Agriculture; Technology; Tape Recording; Audiovisual Aids; Educational Technology; Television; Videotape Recording
• Other Study ID Numbers: 2026-0198; FA (Other Identifier: UW Madison); UWMSN | L&S | Psychology (Other Identifier: UW Madison); 4R33DA059897-03 (U.S. NIH Grant/Contract); Protocol Version 2/10/2026 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No