Mitigating PTSD-CUD Among Women Presenting to Emergency Care After Sexual Assault: Testing a Digital Therapeutic Targeting Anxiety Sensitivity

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Minnesota
Hennepin Assault Response Team
NOT_YET_RECRUITING
Minneapolis
North Carolina
UNC Chapel Hill
NOT_YET_RECRUITING
Chapel Hill
Harbor Shelter
RECRUITING
Smithfield
Nevada
University Medical Center
NOT_YET_RECRUITING
Las Vegas
Oklahoma
Tulsa Forensic Nursing
NOT_YET_RECRUITING
Tulsa
Texas
SAFE Austin
RECRUITING
Austin
Contact Information
Primary
Nicole A Short, PhD
nicole.short@unlv.edu
7028950606
Time Frame
Start Date: 2024-03-14
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 100
Treatments
Experimental: RISE Guide
Brief cognitive behavioral intervention completed in the 3 weeks post-assault delivered via Internet on participants' smartphones targeting anxiety sensitivity, or fear of anxious arousal. Patients learn psychoeducation regarding the nature of stress, cognitive retraining to reduce negative interpretations of stress, and how to complete interoceptive exposures to reduce anxiety sensitivity. These skills are supported by 6 concurrent then subsequent weeks of ecological momentary intervention to deliver personalized intervention reminders based on symptoms.
Active_comparator: Relaxation
Patients will download the Breathe2Relax app, which delivers information about how to use diaphragm breathing (taking slow, deep breaths through the diaphragm) to manage stress. Participants will receive reminders to engage with the intervention. Participants will also receive ecological momentary intervention reminders to engage with the relaxation intervention.
Related Therapeutic Areas
Sponsors
Leads: University of Nevada, Las Vegas
Collaborators: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov