Testing STAR and TextSTAR: A Randomized Controlled Trial

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 years and older
• Women only
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Sexual Violence, Posttraumatic Stress Disorder (PTSD), 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 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) 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

What is being measured

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

1. 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.

   Measured: 1 week

2. 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.

   Measured: 1 week, 1 month, 3 months, 6 months

3. 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.

   Measured: 1 week, 1 month, 3 months, 6 months

4. 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.

   Measured: baseline, 1 month, 3 months, 6 months

5. 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.

   Measured: 1 month, 3 months, 6 months

6. 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.

   Measured: 1 week, 1 month, 3 months, 6 months

7. 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.

   Measured: 1 month, 3 months, 6 months

8. 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: baseline, 1 week, 1 month, 3 months, 6 months

9. 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.

   Measured: baseline, 1 week, 1 month, 3 months, 6 months

Timeline

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

1. First posted5 Jun 2026
2. Study start25 Jun 2026
3. Primary completionJun 2029 (estimated)
4. Study completionDec 2029 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Sexual ViolenceStudies of the same condition, open and under way.
• More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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