N/A Completed N=60 Randomized Triple-blind Prevention

RCT for Innovating Stress-related eHealth

Posttraumatic Stress Disorder · Sexual Assault · Postoperative Pain

Source: ClinicalTrials.gov NCT05305235 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcomePrimary: Treatment Adherence/Acceptability Scale — 57.53 score on a scale

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.