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Mitigating PTSD-CUD After Sexual Assault

NCT05989841 · University of Nevada, Las Vegas
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Mitigating PTSD-CUD Among Women Presenting to Emergency Care After Sexual Assault: Testing a Digital Therapeutic Targeting Anxiety Sensitivity
About this study
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.
Eligibility criteria
Inclusion Criteria: 1. Women sexual assault survivors presenting for emergency care \<72 hours post-assault at 1 of our 4 emergency care sites 2. English speakers 3. 18+ years of age 4. Able to provide informed consent 5. Have a smartphone with continuous service \>1 year 6. Report \>1x/weekly cannabis use on a substance use screener 7. Report elevated AS (\>17 on the Anxiety Sensitivity Index-3) Exclusion Criteria: 1. 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)). 2. Prisoner 3. Currently pregnant 4. Lives with assailant and plans to continue to do so 5. Admitted patient 6. No mailing address 7. Previously enrolled 8. No sexual assault nurse examiner (SANE) examination 9. Reporting current plan and intent for suicide or homicide 10. Does not understand written and spoken English
Study design
Enrollment target: 68 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2024-03-14
Estimated completion: 2028-02-29
Last updated: 2026-01-16
Interventions
Behavioral: RISE GuideBehavioral: Relaxation Control
Primary outcomes
  • Anxiety Sensitivity Index-3 (ASI-3) (6 weeks)
Sponsor
University of Nevada, Las Vegas · other
With: University of North Carolina, Chapel Hill, National Institute on Drug Abuse (NIDA), Hennepin HART, Tulsa Police Department Forensic Nursing, SAFE Austin Harbor Shelter
Contacts & investigators
ContactNicole A Short, PhD · contact · nicole.short@unlv.edu · 7028950606
All locations (6)
Hennepin Assault Response TeamNot Yet Recruiting
Minneapolis, Minnesota, United States
University Medical CenterNot Yet Recruiting
Las Vegas, Nevada, United States
UNC Chapel HillNot Yet Recruiting
Chapel Hill, North Carolina, United States
Harbor ShelterRecruiting
Smithfield, North Carolina, United States
Tulsa Forensic NursingNot Yet Recruiting
Tulsa, Oklahoma, United States
SAFE AustinRecruiting
Austin, Texas, United States
Mitigating PTSD-CUD After Sexual Assault · TrialPath