Testing STAR and TexSTAR: A Video and Text Messaging Intervention
NCT Number: NCT06456190
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sexual Violence|Posttraumatic Stress Disorder|Opioid Use|Opioid Misuse
Interventions: BEHAVIORAL: Skills Training in Active Recovery (STAR) Video|BEHAVIORAL: Text Skills Training in Active Recovery (TextSTAR) program
Sponsor: University of Wisconsin, Madison
Collaborators: National Institute on Drug Abuse (NIDA)
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-06-01
Locations: University of Wisconsin, Madison, Wisconsin, 53792, United States

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 assault to prevent the onset or escalation of PTSD and opioid misuse among survivors of sexual assault.

Primary Outcome Measures: 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: 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