NCT05989841

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
22mo left

Started Mar 2024

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Mar 2024Feb 2028

First Submitted

Initial submission to the registry

May 10, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

March 14, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2028

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

May 10, 2023

Last Update Submit

January 14, 2026

Conditions

Cannabis Use DisorderPosttraumatic Stress Disorder

Outcome Measures

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.

    6 weeks

Secondary Outcomes (8)

  • Marijuana Problems Scale (MPS)

    6 months

  • Marijuana Motives Measure - Coping

    6 months

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

    6 months

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

    6 months

  • Cannabis Use Frequency

    6 weeks

  • +3 more secondary outcomes

Study Arms (2)

RISE Guide

EXPERIMENTAL

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

Relaxation

ACTIVE COMPARATOR

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

Interventions

RISE GuideBEHAVIORAL

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.

RISE Guide
Relaxation ControlBEHAVIORAL

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.

Relaxation

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAssigned female at birth and currently identifying as female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hennepin Assault Response Team

Minneapolis, Minnesota, 55415, United States

NOT YET RECRUITING

University Medical Center

Las Vegas, Nevada, 89102, United States

NOT YET RECRUITING

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

NOT YET RECRUITING

Harbor Shelter

Smithfield, North Carolina, 27577, United States

RECRUITING

Tulsa Forensic Nursing

Tulsa, Oklahoma, 74103, United States

NOT YET RECRUITING

SAFE Austin

Austin, Texas, 74103, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Nicole A Short, PhD

CONTACT

7028950606nicole.short@unlv.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2023

First Posted

August 14, 2023

Study Start

March 14, 2024

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 29, 2028

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

US(6)