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NCT Number: NCT05989841

Mitigating PTSD-CUD After Sexual Assault

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.

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Key information

Conditions

Posttraumatic Stress Disorder Cannabis Use Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hennepin Assault Response Team, Minneapolis, Minnesota, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RISE Guide

Behavioral

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.

Relaxation Control

Behavioral

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 outcomes

  1. Anxiety Sensitivity Index-3 (ASI-3)

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Marijuana Problems Scale (MPS)

    Time frame: 6 months

    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.

  2. Marijuana Motives Measure - Coping

    Time frame: 6 months

    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).

  3. Patient Reported Outcome Measurement Information System - Anxiety Measurement Information System (PROMIS) Anxiety and Depression

    Time frame: 6 months

    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.

  4. Patient Reported Outcome Measurement Information System - Depression Measurement Information System (PROMIS) Anxiety and Depression

    Time frame: 6 months

    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.

  5. Cannabis Use Frequency

    Time frame: 6 weeks

    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. Cannabis Use Quantity

    Time frame: 6 weeks

    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.

  7. Marijuana Cravings - Emotionality Questionnaire

    Time frame: 6 weeks

    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.

  8. PTSD Checklist for Diagnostic and Statistical Manual -5 (DSM-5) (PCL-5)

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole A Short, PhD

CONTACT

[email protected]

7028950606

Sponsors and collaborators

Lead sponsor

University of Nevada, Las Vegas

Other

Collaborators

  • Hennepin HART
  • National Institute on Drug Abuse (NIDA)
  • SAFE Austin Harbor Shelter
  • Tulsa Police Department Forensic Nursing
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Acronym: RISE-C

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 14, 2023
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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