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Sexual ViolenceNCT06456190

Testing STAR and TexSTAR: A Video and Text Messaging Intervention

A study testing Skills Training in Active Recovery (STAR) Video and Text Skills Training in Active Recovery (TextSTAR) program in people with Sexual Violence and Posttraumatic Stress Disorder, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Skills Training in Active Recovery (STAR) Video and Text Skills Training in Active Recovery (TextSTAR) program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
12 Mar 2025to 3 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Skills Training in Active Recovery (STAR) Video, Text Skills Training in Active Recovery (TextSTAR) program
Medical subject headings
Stress Disorders, Post-Traumatic, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Skills Training in Active Recovery (STAR) VideoBehavioural

    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

  • Text Skills Training in Active Recovery (TextSTAR) programBehavioural

    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 groups in NCT06456190
Study groupRoleWhat they receive
Video, Above Threshold, TextExperimentalParticipants 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.
Receives: Behavioral: Skills Training in Active Recovery (STAR) Video; Behavioral: Text Skills Training in Active Recovery (TextSTAR) program
Video, Above Threshold, No TextExperimentalParticipants 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.
Receives: Behavioral: Skills Training in Active Recovery (STAR) Video
Video, Below ThresholdExperimentalParticipants 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.
Receives: Behavioral: Skills Training in Active Recovery (STAR) Video
No Video, Above Threshold, TextExperimentalParticipants 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.
Receives: Behavioral: Text Skills Training in Active Recovery (TextSTAR) program
No Video, Above Threshold, No TextNo interventionParticipants 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 Video, Below ThresholdNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 week to 1 month

  2. 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.

    Measured: 1 week to 1 month

Secondary outcomes (9)

  1. 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.

    Measured: 1 month

  2. 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.

    Measured: 1 month

  3. 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.

    Measured: 1 month

  4. 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.

    Measured: 1 week, 2 week, 3 week, 1 month

  5. 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.

    Measured: 1 month

  6. Opioid craving

    Assessed with the Opioid Craving Visual Analog Scale which ranges from 0 = No Craving At All to 100 = Strongest Craving Ever.

    Measured: 1 week, 2 week, 3 week, 1 month

  7. 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.

    Measured: 1 week, 2 week, 3 week, 1 month

  8. 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.

    Measured: 1 month

  9. 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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2024
  2. Study start12 Mar 2025
  3. Primary completion3 Dec 2025
  4. Study completion3 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06456190
Sponsor's protocol ID
2024-0299
Other IDs
1R61DA059897-01, A487400, L&S/PSYCHOLOGY/PSYCHOLOGY, Protocol Version 8/28/2025
Status last verified
Dec 2025
First submitted
6 Jun 2024
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Walsh K, Stappenbeck CA, Acierno R, Schipani-McLaughlin AM, Mullican KN, Massa AA, Oliver J, McLean SA, McKay S, Carroll B, Stier AL, Reed G, Curran K, Panwalkar S, Gilmore AK. Skills Training in Affective Recovery Video and Text Programs for Recent Sexual Assault Survivors: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2026 Sep 1;9(9):e2636353. doi: 10.1001/jamanetworkopen.2026.36353.

    PubMed 42814464

  • Walsh K, Schipani-McLaughlin AM, Stappenbeck CA, Massa AA, Oliver J, McLean SA, McKay S, Carroll B, Stier AL, Curran K, Acierno R, Panwalkar S, Gilmore AK. Feasibility and acceptability of skills training in affective recovery (STAR) video and TextSTAR text message program for recent sexual assault survivors. Eur J Psychotraumatol. 2026 Dec;17(1):2696639. doi: 10.1080/20008066.2026.2696639. Epub 2026 Aug 24.

    PubMed 42635087

Questions about this trial

What is this clinical trial studying?

A study testing Skills Training in Active Recovery (STAR) Video and Text Skills Training in Active Recovery (TextSTAR) program in people with Sexual Violence and Posttraumatic Stress Disorder, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Opioid Misuse (time frame: 1 week to 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06456190, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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