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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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anxiety Sensitivity Index-3 (ASI-3)

Secondary study objectives

Cannabis Use Frequency

Cannabis Use Quantity

Marijuana Cravings - Emotionality Questionnaire

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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