RECRUITING

Mitigating PTSD-CUD After Sexual Assault

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-12-15
Study Completion:2027-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05989841

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Women sexual assault survivors presenting for emergency care \<72 hours post-assault at 1 of our 4 emergency care sites
  2. 2. English speakers
  3. 3. 18+ years of age
  4. 4. Able to provide informed consent
  5. 5. Have a smartphone with continuous service \>1 year
  6. 6. Report \>1x/weekly cannabis use on a substance use screener
  7. 7. Report elevated AS (\>17 on the Anxiety Sensitivity Index-3)
  1. 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. 2. Prisoner
  3. 3. Currently pregnant
  4. 4. Lives with assailant and plans to continue to do so
  5. 5. Admitted patient
  6. 6. No mailing address
  7. 7. Previously enrolled
  8. 8. No sexual assault nurse examiner (SANE) examination
  9. 9. Reporting current plan and intent for suicide or homicide
  10. 10. Does not understand written and spoken English

Contacts and Locations

Study Contact

Nicole A Short, PhD
CONTACT
7028950606
nicole.short@unlv.edu

Study Locations (Sites)

Hennepin Assault Response Team
Minneapolis, Minnesota, 55415
United States
University Medical Center
Las Vegas, Nevada, 89102
United States
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Harbor Shelter
Smithfield, North Carolina, 27577
United States
Tulsa Forensic Nursing
Tulsa, Oklahoma, 74103
United States
SAFE Austin
Austin, Texas, 74103
United States

Collaborators and Investigators

Sponsor: University of Nevada, Las Vegas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-15
Study Completion Date2027-02-28

Study Record Updates

Study Start Date2023-12-15
Study Completion Date2027-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Posttraumatic Stress Disorder
  • Cannabis Use Disorder