Clinical trial NCT05989841: Mitigating PTSD-CUD After Sexual Assault
Official title: Mitigating PTSD-CUD Among Women Presenting to Emergency Care After Sexual Assault: Testing a Digital Therapeutic Targeting Anxiety Sensitivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Cannabis Use Disorder
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2023-08-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 Criteria:

1. Women sexual assault survivors presenting for emergency care \<72 hours post-assault at 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 Criteria:

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. 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

Primary outcomes:
measure: Anxiety Sensitivity Index-3 (ASI-3)
timeFrame: 6 weeks
Secondary outcomes:
measure: Marijuana Problems Scale (MPS)
timeFrame: 6 months
measure: Marijuana Motives Measure - Coping
timeFrame: 6 months
measure: Patient Reported Outcome Measurement Information System - Anxiety Measurement Information System (PROMIS) Anxiety and Depression
timeFrame: 6 months
measure: Patient Reported Outcome Measurement Information System - Depression Measurement Information System (PROMIS) Anxiety and Depression
timeFrame: 6 months
measure: Cannabis Use Frequency
timeFrame: 6 weeks
measure: Cannabis Use Quantity
timeFrame: 6 weeks
measure: Marijuana Cravings - Emotionality Questionnaire
timeFrame: 6 weeks
measure: PTSD Checklist for Diagnostic and Statistical Manual -5 (DSM-5) (PCL-5)
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Assault Response Team
state: Minnesota
city: Las Vegas
country: United States
facility: University Medical Center
state: Nevada
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Smithfield
country: United States
facility: Harbor Shelter
state: North Carolina
city: Tulsa
country: United States
facility: Tulsa Forensic Nursing
state: Oklahoma
city: Austin
country: United States
facility: SAFE Austin
state: Texas
Study officials:
References: