Mitigating PTSD-CUD After Sexual Assault

Last updated: January 21, 2025
Sponsor: University of Nevada, Las Vegas
Overall Status: Active - Recruiting

Phase

N/A

Condition

Post-traumatic Stress Disorders

Treatment

Relaxation Control

RISE Guide

Clinical Study ID

NCT05989841
UNLV-2023-649
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Women sexual assault survivors presenting for emergency care <72 hours post-assaultat 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

Exclusion Criteria:

  1. Inability to provide informed consent (e.g., serious injury preventing the abilityto hear, speak, or see to consent and participate, or other causes (e.g., diagnosedcognitive 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

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Relaxation Control
Phase:
Study Start date:
December 15, 2023
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • Hennepin Assault Response Team

    Minneapolis, Minnesota 55415
    United States

    Site Not Available

  • University Medical Center

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • UNC Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Harbor Shelter

    Smithfield, North Carolina 27577
    United States

    Active - Recruiting

  • Tulsa Forensic Nursing

    Tulsa, Oklahoma 74103
    United States

    Site Not Available

  • SAFE Austin

    Austin, Texas 74103
    United States

    Active - Recruiting

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