Mitigating PTSD-CUD After Sexual Assault
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Nevada, Las Vegas
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
RISE Guide
BehavioralBrief 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.
Relaxation Control
BehavioralPatients 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.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: RISE GuideExperimental treatment 1 intervention
Group B: RelaxationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Anxiety Sensitivity Index-3 (ASI-3)
18-item self-report measure of anxiety sensitivity assessing all three subdomains of anxiety sensitivity (physical, cognitive, social). Participants respond to 18 items (e.g., It scares me when my heart beats rapidly) on a 4-point Likert scale. Scores range from 0-72, with higher scores indicating higher levels of anxiety sensitivity.
Time frame
6 weeksSecondary outcomes
1
Marijuana Problems Scale (MPS)
19-item self-report measure of problems related to cannabis use (e.g., problems with work, school, social functioning). Participants rate 19 items on a 3- point Likert scale. Scores range from 0 to 38, with higher scores indicating more problems related to cannabis use.
Time frame
6 months2
Marijuana Motives Measure - Coping
The MMM is a 25-item self-report measure of cannabis motives, including coping-oriented motives for cannabis use. Participants respond to a list of motives (e.g., to forget my worries, to get high) on a 5-point Likert scale. Scores range from 25 to 125 for the entire measure, with higher scores indicating higher levels of various types of marijuana motives. The primary motive that will be used as an outcome is coping motives (scores range from 4 to 20 on this subscale).
Time frame
6 months3
Patient Reported Outcome Measurement Information System - Anxiety Measurement Information System (PROMIS) Anxiety and Depression
7-items assessing self-reported symptoms of anxiety (e.g., anxious, worried, nervous) rated on a 5-point scale. Scores range from 7 to 35, with higher scores indicating higher levels of anxiety. T-scores are used for final scoring.
Time frame
6 months4
Patient Reported Outcome Measurement Information System - Depression Measurement Information System (PROMIS) Anxiety and Depression
8 items assessing self-reported symptoms of depression (e.g., worthlessness, helplessness, sadness) rated on a 5-point scale. Scores range from 8 to 40, with higher scores indicating higher levels of depression. T-scores are used for final scoring.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Nevada, Las Vegas
Lead sponsor
University of North Carolina, Chapel Hill
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Hennepin HART
Collaborator
Tulsa Police Department Forensic Nursing
Collaborator
SAFE Austin Harbor Shelter
Collaborator
Source ClinicalTrials.gov