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Recruiting NCT05989841

Mitigating PTSD-CUD After Sexual Assault

Phase I / Phase II Interventional Posttraumatic Stress Disorder Cannabis Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RISE Guide, Relaxation Control.
Who it may be relevant to
Registry conditions: Posttraumatic Stress Disorder, Cannabis Use Disorder. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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 d
  • 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.

Primary outcome measures

  • Anxiety Sensitivity Index-3 (ASI-3) [Time frame: 6 weeks]
Secondary outcome measures (8)
  • Marijuana Problems Scale (MPS) [Time frame: 6 months]
  • Marijuana Motives Measure - Coping [Time frame: 6 months]
  • Patient Reported Outcome Measurement Information System - Anxiety Measurement Information System (PROMIS) Anxiety and Depression [Time frame: 6 months]
  • Patient Reported Outcome Measurement Information System - Depression Measurement Information System (PROMIS) Anxiety and Depression [Time frame: 6 months]
  • Cannabis Use Frequency [Time frame: 6 weeks]
  • Cannabis Use Quantity [Time frame: 6 weeks]
  • Marijuana Cravings - Emotionality Questionnaire [Time frame: 6 weeks]
  • PTSD Checklist for Diagnostic and Statistical Manual -5 (DSM-5) (PCL-5) [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 6 centers
  • Hennepin Assault Response Team — Minneapolis
  • University Medical Center — Las Vegas
  • UNC Chapel Hill — Chapel Hill
  • Harbor Shelter — Smithfield
  • Tulsa Forensic Nursing — Tulsa
  • SAFE Austin — Austin

Identifiers

NCT: NCT05989841 · UNLV-2023-649 · 1K23DA054299-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗