Status:

COMPLETED

RCT for Innovating Stress-related eHealth

Lead Sponsor:

University of North Carolina, Chapel Hill

Collaborating Sponsors:

Mayday Fund

Conditions:

Posttraumatic Stress Disorder

Sexual Assault

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief 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...

Detailed Description

The RISE Study plans to recruit up to 60 women (natal and self-identifying) who present for Sexual Assault Nurse Examiner (SANE) care within 72 hours of experiencing sexual assault. Willing participan...

Eligibility Criteria

Inclusion

  • Women sexual assault survivors presenting for emergency care \<72 hours post-assault at one of our study locations.
  • English speakers
  • 18+ years of age
  • Able to provide informed consent
  • Have a smartphone with continuous service \>1 year

Exclusion

  • 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 SANE examination

Key Trial Info

Start Date :

December 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 24 2024

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT05305235

Start Date

December 1 2021

End Date

February 24 2024

Last Update

March 5 2025

Active Locations (2)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

1

University of North Carolina at Chapel Hill, SANE Program

Chapel Hill, North Carolina, United States, 27599

2

Austin Stop Abuse for Everyone (SAFE)

Austin, Texas, United States, 78760

RCT for Innovating Stress-related eHealth | DecenTrialz