CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 75 enrolled
Drug / intervention
RISE Guide +1 moredevice
Likely dose
RISE Guide smartphone-based intervention using Cognitive Bias Modification or Relaxation Control guidance (specific dosing/frequency not specified)AI-extracted
Key inclusion· 5
  • Women who are sexual assault survivors presenting for emergency care within 72 hours post-assault at study locations
  • Age 18 years or older
  • English-speaking
  • Able to provide informed consent
Key exclusion· 8
  • Unable to provide informed consent due to serious injury or cognitive deficits
  • Currently incarcerated
  • Currently pregnant
  • Lives with the assailant and plans to continue living with them

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05305235
NCT05305235N/ACompleted

Development of a Digital Therapeutic Targeting Anxiety Sensitivity to Reduce Posttraumatic Stress in Women Presenting for Emergency Care After Sexual Assault

University of North Carolina, Chapel Hill·interventional·Posted Mar 31, 2022·Updated Mar 5, 2025

In Brief

A clinical study evaluating RISE Guide and Relaxation Control for Posttraumatic Stress Disorder and 2 related conditions. Completed, enrolled 75 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMayday Fund

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 31, 2022
Enrollment StartDec 1, 2021
Primary CompletionFeb 24, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.3 years ago

Interventions

RISE Guidedevice

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

Relaxation Controldevice

Guides users through relaxation techniques.