Mitigating PTSD-CUD After Sexual Assault (RISE-C)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Disorder; Cannabis Use Disorder
• Intervention / Treatment: Behavioral: RISE Guide; Behavioral: Relaxation Control

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Nicole A Short, PhD; Phone Number: 7028950606; Email: nicole.short@unlv.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Not yet recruiting
      • Hennepin Assault Response Team
      • Contact: Jeffrey Ho, MD; Phone Number: 2 (612) 873-5832; Email: jeffrey.ho@hcmed.org
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Not yet recruiting
      • University Medical Center
      • Principal Investigator: Jordana Haber, MD
      • Contact: Jordana Haber, MD; Phone Number: (702) 383-2000; Email: jordana.haber@unlv.edu
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Not yet recruiting
      • UNC Chapel Hill
      • Principal Investigator: Karen Serrano, MD
      • Contact: Karen Serrano, MD; Phone Number: (919) 966-6442; Email: kserrano@email.unc.edu
    • Smithfield, North Carolina, United States, 27577
      • Recruiting
      • Harbor Shelter
      • Contact: Laurie Mayenschein; Phone Number: 919-628-3380; Email: lmayenschein@harborshelter.org
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74103
      • Not yet recruiting
      • Tulsa Forensic Nursing
      • Principal Investigator: Kasey Magness, BSN
      • Contact: Kasey Magness, BSN; Phone Number: 9187435763; Email: kmagness@cityoftulsa.org
  • Texas
    • Austin, Texas, United States, 74103
      • Recruiting
      • SAFE Austin
      • Principal Investigator: Jenny Black, BSN
      • Contact: Jenny Black, BSN; Phone Number: 512.267.7233; Email: jblack@safeaustin.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 deliver personalized intervention reminders based on symptoms.	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 deliver personalized intervention reminders based on symptoms.
Active Comparator: Relaxation; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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).	6 months
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.	6 months
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.	6 months
Cannabis Use Frequency	Ecological momentary assessment will include self-report measures of whether or not cannabis was used that day (yes/no). The item will be scored as 0 (no) vs. 1 (yes), with higher scores indicating higher levels of cannabis use frequency.	6 weeks
Cannabis Use Quantity	Ecological momentary assessment will assess quantity of cannabis used on an 8-point scale, assessed 1x/day over 6 weeks. Scores will range from 1-8, with higher scores indicating a higher quantity of cannabis consumed.	6 weeks
Marijuana Cravings - Emotionality Questionnaire	Ecological momentary assessment will include a state version of the emotionality subscale of the Marijuana Cravings Questionnaire. This consists of 4 items rated on a 7-point Likert scale, assessed 4x/day over 6 weeks. Scores range from 4 to 28, with higher scores indicating higher levels of cravings.	6 weeks
PTSD Checklist for Diagnostic and Statistical Manual -5 (DSM-5) (PCL-5)	20-item self-report measure of DSM-5 PTSD symptoms, including 4 symptom clusters of PTSD (re-experiencing, avoidance, negative alterations in cognition and mood, alterations in arousal and reactivity). Participants respond to items corresponding to each DSM-5 symptom of PTSD on a 5-point Likert scale (0 to 4). Scores range from 0 to 80, with higher scores indicating higher levels of PTSD symptoms.	6 months

Collaborators and Investigators

• Sponsor: University of Nevada, Las Vegas
• Collaborators: National Institute on Drug Abuse (NIDA); University of North Carolina, Chapel Hill; Hennepin HART; Tulsa Police Department Forensic Nursing; SAFE Austin Harbor Shelter

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 29, 2028

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: UNLV-2023-649; 1K23DA054299-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No