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RCT for Innovating Stress-related eHealth

NCT05305235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-03-05

Study results available
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Summary

The Randomized Control Trial for Innovating Stress-related eHealth (RISE) Study tests the hypotheses that a highly promising digital therapeutic (RISE Guide) targeting anxiety sensitivity (AS) will be acceptable to women sexual assault survivors; reduce survivors' anxiety sensitivity, and, in turn, posttraumatic stress.

If successful, RISE Guide could be provided at no cost to all women who present to US emergency departments for emergency care after sexual assault.

Conditions

Interventions

DEVICE

RISE Guide

Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.

DEVICE

Relaxation Control

Guides users through relaxation techniques.

Sponsors & Collaborators

  • Mayday Fund

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Samuel A. McLean, MD, MPH · University of North Carolina, Chapel Hill

  • Nicole A. Short, PhD · University of Nevada, Las Vegas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-02-24
Completion
2024-02-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05305235 on ClinicalTrials.gov