Testing STAR and TextSTAR for Sexual Violence, PTSD, and Opioid Misuse
This study is testing two interventions, Skills Training in Active Recovery (STAR) Video and Text Skills Training in Active Recovery (TextSTAR) program, to help women who have recently experienced sexual assault. The STAR Video is a 17-minute video offering information about posttraumatic stress disorder (PTSD) and substance misuse, along with coping tips. The TextSTAR program is a 3-week daily text message program with similar supportive messages and coping tips. Researchers want to see if these interventions can reduce mental health problems and opioid misuse after an assault. You may be able to join if you are a woman aged 18 or older, can read English, and received a medical exam for an assault within the last week. The study aims to enroll 394 participants. Success will be measured by changes in opioid misuse, acute stress, PTSD, and other drug use over time.
- Study design
- This is an interventional study, meaning participants will receive a specific intervention. It is a randomized controlled trial, which means participants are assigned by chance to different groups. The study plans to enroll 394 women.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for changes in symptoms at 1 week, 1 month, 3 months, and 6 months after the assault.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Testing STAR and TextSTAR: A Randomized Controlled Trial
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Kate Walsh, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Opioid misuse1 week
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.
- Change in acute stress/ posttraumatic stress1 week, 1 month, 3 months, 6 months
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.
- Change in Tobacco, Alcohol, and Other Drug Use Frequency1 week, 1 month, 3 months, 6 months
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.
- Substance use severitybaseline, 1 month, 3 months, 6 months
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.
- Depression symptoms1 month, 3 months, 6 months
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.
- Mindfulness skills usage1 week, 1 month, 3 months, 6 months
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.
- Perceived control over recovery process1 month, 3 months, 6 months
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.
- Pain severitybaseline, 1 week, 1 month, 3 months, 6 months
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.
- Opioid cravingbaseline, 1 week, 1 month, 3 months, 6 months
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.