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)
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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