Testing STAR and TexSTAR: A Video and Text Messaging Intervention

Testing STAR and TextSTAR: A Video and Text Messaging Intervention for Recent Sexual Violence Survivors

This NIDA-funded HEAL Initiative: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence R61 seeks to develop and test a brief video intervention to deliver during Sexual Assault Nurse Examiner (SANE) care and a brief text messaging intervention to deliver in the month after the assault to prevent the onset or escalation of PTSD and opioid misuse among survivors of sexual assault.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder; Sexual Violence; Opioid Use; Opioid Misuse
• Intervention / Treatment: Behavioral: Skills Training in Active Recovery (STAR) Video; Behavioral: Text Skills Training in Active Recovery (TextSTAR) program

Detailed Description

This pilot trial is part of a larger R61/R33 to test the effectiveness of brief video and text messaging interventions on PTSD and opioid misuse among recent survivors of sexual assault presenting for medical care. In the R61 phase, researchers are working with a sexual assault advisory board to develop the video and text interventions. The research team is partnering with 5-6 Sexual Assault Nurse Examiner programs across the United States to recruit 50 participants. In this pilot trial, researchers aim to test the feasibility of recruitment strategies, acceptability of the interventions among survivors, and preliminary effectiveness of the interventions at addressing PTSD and opioid misuse.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • 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:

• Are 18 or older
• Can read and respond to questions in English
• Are receiving a SANE exam for sexual 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:

• Patients under age 18
• Those who cannot read and respond to questionnaires in English
• Those seeking care that does not include a SANE exam
• Those who cannot consent to receive SANE 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 (e.g., suspects, those who have experienced sexual assault within a prison setting and are returning to that setting, etc)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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: Skills Training in Active Recovery (STAR) Video; a 12-15 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
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 12-15 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 12-15 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
Change in Opioid Misuse	Assessed using Tobacco, Alcohol, Prescription Medication, and Other Substance (TAPS) Tool. 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. Any response other than "never" on the TAPS-1 indicates a positive screen, which leads to administration of the TAPS-2. The TAPS-2 is a brief assessment including 3-4 yes/no questions for each class of substances assessing level of use, dependence, and concern from others. Cut-offs for problematic substance use and substance use disorder are based on scores on the TAPS-2.	1 week to 1 month
Change in Posttraumatic Stress Disorder	Assessed using 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 to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco, Alcohol, and Other Drug Use	Tobacco, Alcohol, Prescription Medication, and Other Substance (TAPS) Tool. The TAPS-1 is a screener with 4 items assessing frequency of use of tobacco, alcohol, prescription medication, and illicit substances. Any response other than "never" on the TAPS-1 indicates a positive screen, which leads to administration of the TAPS-2. The TAPS-2 is a brief assessment including 3-4 yes/no questions for each class of substances assessing level of use, dependence, and concern from others. Cut-offs for problematic substance use and substance use disorder are based on scores on the TAPS-2.	1 month
Opioid misuse severity	Assessed using Current Opioid Misuse Measure (COMM), which is a brief patient self-assessment to monitor chronic pain patients on opioid therapy. It is a 17-item questionnaire with a 0-4 point Likert scale. Scores range from 0-68, with higher scores (above 9) indicating the participant may be exhibiting aberrant behaviors associated with misuse of opioid medications.	1 month
Depression level	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
Mindfulness skills usage	Assessed with 10 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 to 3 = 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. Higher scores reflect greater skills utilization.	1 week, 2 week, 3 week, 1 month
Perceived control over recovery process	Assessed with the 8-item Perceived Present Control subscale of the Perceived Control Over Stressful Events Scale. The scale has excellent psychometric properties and higher scores (which reflect greater perceived control) have been associated with recovery following sexual violence.	1 month
Opioid craving	Assessed with the Opioid Craving Visual Analog Scale which ranges from 0 = No Craving At All to 100 = Strongest Craving Ever.	1 week, 2 week, 3 week, 1 month
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.	1 week, 2 week, 3 week, 1 month
Alcohol use severity	Assessed with the 10-item Alcohol Use Disorders Identification Test (AUDIT), which quantifies consequences or problems associated with alcohol use. Scores of 8 or higher on the AUDIT indicate substantial alcohol problems.	1 month
Drug use severity	Assessed with the 10-item Drug Abuse Screening Test (DAST-10), which quantifies consequences or problems associated with drug use. Scores of 6 or higher or the DAST-10 indicate substantial drug use problems.	1 month

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 (Actual): March 12, 2025
• Primary Completion (Actual): December 3, 2025
• Study Completion (Actual): December 3, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

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: 2024-0299; A487400 (Other Identifier: UW Madison); L&S/PSYCHOLOGY/PSYCHOLOGY (Other Identifier: UW Madison); 1R61DA059897-01 (U.S. NIH Grant/Contract); Protocol Version 8/28/2025 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No