Mitigating PTSD-CUD Among Women Presenting to Emergency Care After Sexual Assault: Testing a Digital Therapeutic Targeting Anxiety Sensitivity
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 68
- Locations
- 12
- Primary Endpoint
- Anxiety Sensitivity Index-3 (ASI-3)
Study Overview
Brief Summary
683,000 women are sexually assaulted annually in the United States, half of whom develop chronic posttraumatic stress disorder (PTSD) and thus have markedly increased risk for cannabis use disorder (CUD). The current proposal will test the acceptability, initial efficacy, and mechanisms underlying a novel digital therapeutic targeting risk for PTSD-CUD, which could address the critical need for PTSD-CUD prevention for the 100,000 women who annually present for emergency care after sexual assault. In this research context, the applicant will receive key training in multisite, emergency-care based randomized clinical trials (RCTs), advanced statistical analyses for RCTs and ecological momentary assessment data, biobehavioral mechanisms underlying PTSD-CUD prevention, and professional development, launching her independent research career focused on reducing the public health burden of PTSD-CUD among sexual assault survivors by leveraging digital therapeutics.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women sexual assault survivors presenting for emergency care <72 hours post-assault at 1 of our 4 emergency care sites
- •English speakers
- •18+ years of age
- •Able to provide informed consent
- •Have a smartphone with continuous service >1 year
- •Report >1x/weekly cannabis use on a substance use screener
- •Report elevated AS (>17 on the Anxiety Sensitivity Index-3)
Exclusion Criteria
- •Inability to provide informed consent (e.g., serious injury preventing the ability to hear, speak, or see to consent and participate, or other causes (e.g., diagnosed cognitive deficits, diagnosed dementia, asleep at time of screening)).
- •Currently pregnant
- •Lives with assailant and plans to continue to do so
- •Admitted patient
- •No mailing address
- •Previously enrolled
- •No sexual assault nurse examiner (SANE) examination
- •Reporting current plan and intent for suicide or homicide
- •Does not understand written and spoken English
Outcomes
Primary Outcomes
Anxiety Sensitivity Index-3 (ASI-3)
Time Frame: 6 weeks
18-item self-report measure of anxiety sensitivity assessing all three subdomains of anxiety sensitivity (physical, cognitive, social). Participants respond to 18 items (e.g., It scares me when my heart beats rapidly) on a 4-point Likert scale. Scores range from 0-72, with higher scores indicating higher levels of anxiety sensitivity.
Secondary Outcomes
- Patient Reported Outcome Measurement Information System - Anxiety Measurement Information System (PROMIS) Anxiety and Depression(6 months)
- Cannabis Use Quantity(6 weeks)
- Patient Reported Outcome Measurement Information System - Depression Measurement Information System (PROMIS) Anxiety and Depression(6 months)
- Marijuana Cravings - Emotionality Questionnaire(6 weeks)
- PTSD Checklist for Diagnostic and Statistical Manual -5 (DSM-5) (PCL-5)(6 months)
- Cannabis Use Frequency(6 weeks)
- Marijuana Problems Scale (MPS)(6 months)
- Marijuana Motives Measure - Coping(6 months)