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

January 14, 2026 updated by: University of Nevada, Las Vegas

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Not yet recruiting
        • Hennepin Assault Response Team
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Not yet recruiting
        • University Medical Center
        • Principal Investigator:
          • Jordana Haber, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Not yet recruiting
        • UNC Chapel Hill
        • Principal Investigator:
          • Karen Serrano, MD
        • Contact:
      • Smithfield, North Carolina, United States, 27577
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74103
        • Not yet recruiting
        • Tulsa Forensic Nursing
        • Principal Investigator:
          • Kasey Magness, BSN
        • Contact:
    • Texas
      • Austin, Texas, United States, 74103
        • Recruiting
        • SAFE Austin
        • Principal Investigator:
          • Jenny Black, BSN
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 months
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).
6 months
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.
6 months
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.
6 months
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 weeks
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.
6 weeks
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.
6 weeks
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nevada, Las Vegas

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 29, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings