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Behavioral Intervention

Digital Therapeutics for PTSD and Cannabis Use Disorder (RISE-C Trial)

N/A
Recruiting
Research Sponsored by University of Nevada, Las Vegas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

RISE-C Trial Summary

This trial will test if digital therapeutics could reduce the risk of PTSD & cannabis use disorder for the 100,000 women sexually assaulted annually in the US.

Who is the study for?
This trial is for English-speaking women over 18 who have experienced a sexual assault within the last 72 hours and are seeking emergency care. They must use cannabis more than once weekly, have high anxiety sensitivity, own a smartphone with service for over a year, and be able to consent. Exclusions include living with the assailant, being an admitted patient or prisoner, cognitive impairments preventing informed consent, current pregnancy, no fixed address or prior enrollment.Check my eligibility
What is being tested?
The study tests a new digital therapeutic called RISE Guide against Relaxation Control to prevent PTSD-CUD in women after sexual assault. It aims to evaluate user acceptability and effectiveness of these interventions in reducing PTSD-CUD risk among survivors presenting at emergency care sites.See study design
What are the potential side effects?
Since this trial involves digital therapeutics rather than medication, traditional side effects like those seen with drugs are not expected. However, participants may experience discomfort or emotional distress when engaging with content related to trauma as part of the therapy.

RISE-C Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anxiety Sensitivity Index-3 (ASI-3)
Secondary outcome measures
Cannabis Use Frequency
Cannabis Use Quantity
Marijuana Cravings - Emotionality Questionnaire
+5 more

RISE-C Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RISE GuideExperimental Treatment1 Intervention
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.
Group II: RelaxationActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RISE Guide
2021
N/A
~60

Find a Location

Who is running the clinical trial?

University of Nevada, Las VegasLead Sponsor
66 Previous Clinical Trials
13,699 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,508 Previous Clinical Trials
4,190,725 Total Patients Enrolled

Media Library

Relaxation Control (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05989841 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Relaxation, RISE Guide
Post-Traumatic Stress Disorder Clinical Trial 2023: Relaxation Control Highlights & Side Effects. Trial Name: NCT05989841 — N/A
Relaxation Control (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05989841 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for those wishing to take part in this research?

"The clinical trial in question is unfortunately not recruiting patients, with the last update being on August 10th 2023. However, there are 421 other trials accepting participants at this time according to data hosted on ClinicalTrials.gov"

Answered by AI

In what locales is this clinical experiment being conducted?

"Currently, 4 locations are enrolling participants for this trial; Chapel Hill, Tulsa, Austin and several other cities. To reduce the need to travel too far from your residence if you join the study, it is advisable that you select a clinic closest to you."

Answered by AI

Who else is applying?

What site did they apply to?
UNC Chapel Hill
Tulsa Forensic Nursing
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

Ptsd ..weed smoker ants.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Mitigating PTSD-CUD After Sexual Assault
2023. "Mitigating PTSD-CUD After Sexual Assault". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05989841.
All > Ptsd Las Vegas > Paid Studies Las Vegas
~67 spots leftby Feb 2026
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