Opioid Misuse, Posttraumatic Stress Disorder (PTSD), Sexual Violence
Conditions
Brief summary
The goal of this clinical trial is to learn whether a video given for recent sexual assault survivors and/or a 3-week text messaging intervention with similar content is effective at reducing mental health problems and substance misuse following the assault.
Detailed description
This NIDA-funded HEAL Initiative: Opioid Use Disorder Care Pathways for Individuals with Histories of Exposure to Violence R33 seeks to test a brief video and text messaging intervention to deliver during Sexual Assault Medical Forensic Examiner (SAMFE) care to prevent the onset or escalation of PTSD and opioid misuse among survivors of sexual assault. The investigators will test whether the video is associated with reductions in symptoms and whether for those above threshold on PTSD and opioid misuse symptoms at 1 week, the text message program is associated with reductions in symptoms at 1, 3, and 6 months post-assault.
Interventions
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
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
Sponsors
University of Wisconsin, Madison
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 or older * Can read and respond to questions in English * Are receiving a SAMFE exam for a 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
* Under age 18 * Those who cannot read and respond to questionnaires in English * Those seeking care that does not include a SAMFE exam * Those who cannot consent to receive SAMFE 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid misuse | 1 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 stress | 1 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 Frequency | 1 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 severity | baseline, 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 symptoms | 1 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 usage | 1 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 process | 1 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 severity | baseline, 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 craving | baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual violence stigma | 1 month, 3 months, 6 months | Assessed via the 9-item Sexual Violence Related Stigma Scale which asks about individual, interpersonal, and societal aspects of stigma. It is rated on a 4-point Likert scale, where 0= strongly disagree and 3= strongly agree. Scores range from 0-27. Higher total scores indicate a greater severity of sexual violence-related stigma experienced or internalized by the survivor. |
| Emotion dysregulation | 1 month, 3 months, 6 months | Assessed via the Difficulties in Emotion Regulation Scale - 16 item version (DERS-16), which asks about the frequency with which individuals experience difficulties in emotion regulation from 1 = not at all to 5 = almost always. Items are summed so total scores range from 16-80, with higher scores indicating greater difficulties in emotion regulation. |
| Social support | 1 month, 3 months, 6 months | Assessed using the The Multidimensional Scale of Perceived Social Support (MSPSS). MSPSS is a 12-item tool measuring support from family, friends, and significant others using a 7-point Likert scale (1=Very Strongly Disagree to 7=Very Strongly Agree). Total scores range from 12 to 84, with higher scores indicating greater perceived support. |
| Self-compassion | 1 month, 3 months, 6 months | Assessed via 6 items from the Self Compassion Scale-Short Form (SCS-SF) that assess self-kindness, common humanity, and mindfulness on a scale from 1 = almost never to 5 = almost always. Items are averaged so total scores range from 1-5 where higher scores show higher self compassion. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKate Walsh, PhD
University of Wisconsin, Madison
Outcome results
None listed