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RECRUITING
NCT05989841
PHASE1/PHASE2

Mitigating PTSD-CUD After Sexual Assault

Sponsor: University of Nevada, Las Vegas

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2024-03-14

Completion Date

2028-02-29

Last Updated

2026-01-16

Healthy Volunteers

No

Interventions

BEHAVIORAL

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.

BEHAVIORAL

Relaxation Control

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.

Locations (6)

Hennepin Assault Response Team

Minneapolis, Minnesota, United States

University Medical Center

Las Vegas, Nevada, United States

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Harbor Shelter

Smithfield, North Carolina, United States

Tulsa Forensic Nursing

Tulsa, Oklahoma, United States

SAFE Austin

Austin, Texas, United States