N/A
N=60
RCT for Innovating Stress-related eHealth
Posttraumatic Stress Disorder · Sexual Assault · Pain
Bottom Line
View on ClinicalTrials.gov: NCT05305235 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Treatment Adherence/Acceptability Scale — 57.53 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RISE Guide (Device); Relaxation Control (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Adherence/Acceptability Scale |
57.53 | — |
| SECONDARY Credibility/Expectancy Questionnaire |
22.85; 18.61 | — |
| SECONDARY Treatment Utilization and Acceptability |
12.45; 10.89 | — |
| SECONDARY Average Number of Participants Successfully Randomized Per Month Over the Entirety of the Study |
2 | — |
| SECONDARY Final Proportion of Participants Who Completed Follow-ups |
0.85; 0.67; 0.70; 0.52 | — |
| SECONDARY Unexpected Adverse Events by Event |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Women sexual assault survivors presenting for emergency care 1 year
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05305235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.