RecruitingPhase 1Phase 2NCT05989841

Mitigating PTSD-CUD After Sexual Assault

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

Sponsor

University of Nevada, Las Vegas

Enrollment

68 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

Cannabis Use Disorder Posttraumatic Stress Disorder

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

Women sexual assault survivors presenting for emergency care \<72 hours post-assault at 1 of our 4 emergency care sites
English speakers
+ 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)

Exclusion Criteria10

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)).
Prisoner
Currently pregnant
Lives with assailant and plans to continue to do so
Admitted patient
No mailing address
Previously enrolled
No sexual assault nurse examiner (SANE) examination
Reporting current plan and intent for suicide or homicide
Does not understand written and spoken English

Interventions

BEHAVIORALRISE 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.

BEHAVIORALRelaxation 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.