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.
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 participants will complete enrollment procedures (i.e., consent forms and initial survey) during this same, initial SANE care visit. All enrolled participants will complete 4/day ecological momentary assessments (EMAs; day 1 through day 49) and complete a follow-up assessment at week 1. More information on EMA and week 1 assessment content is available in the "Outcome Measurements" section of this listing. Following their week 1 survey, all participants will be randomized into either the active (RISE Guide) or control (Breathe2Relax app) condition. Participants will receive a link to their assigned intervention. Participants in the active condition will additionally begin receiving ecological momentary interventions (EMIs) at the end of their ecological momentary assessments, which consist of personalized feedback based on symptoms reported during EMAs. All participants will receive an Empatica wristband in the mail. Participants will wear the wristband week 1 through week 7 and press a button on the wristband's interface whenever they experience internal (e.g. thought) or external (e.g. seeing the assailant in public) trauma reminders. The wristband will collect continuous data on participants' heart rate, temperature, and perspiration, which will be used as measurements of stress reactivity. All participants will complete further follow-up assessments at week 7, month 6, and month 12.\* More information on each follow-up assessment's content is available in the "Outcome Measurements" section of this listing. \*The month 12 follow-up assessment was removed via an IRB modification approved on December 14, 2022. Participants enrolled after December 14, 2022 will not complete this timepoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.
Guides users through relaxation techniques.
University of North Carolina at Chapel Hill, SANE Program
Chapel Hill, North Carolina, United States
Austin Stop Abuse for Everyone (SAFE)
Austin, Texas, United States
Treatment Adherence/Acceptability Scale
The Treatment Adherence/Acceptability Scale (TAAS) is a 10-item measure of treatment acceptability (e.g., I would recommend this treatment to a friend) and adherence (e.g., I would be able to finish \[this treatment\]) that participants rate on a 7-point Likert scale with scores ranging from 10-70. Higher scores indicate higher acceptability.
Time frame: 1 Week
Credibility/Expectancy Questionnaire
Credibility/Expectancy Questionnaire (CEQ; 1 week) 6-item measure of treatment credibility and expectancy of treatment to improve symptoms. Items are rated on 9-to-11-point Likert scales. 11-point scales (0-100% in 10% intervals are recoded to align with the 1-9 scales). Higher scores indicate higher credibility/expectancy. Scores can range from 4 to 56.
Time frame: 7 Week
Treatment Utilization and Acceptability
6 items self-report survey created for the current study on a 5-point Likert scale, such as How often did you log in? How interested were you? and 4 open-ended questions; e.g., What did you like about RISE Guide?; What did you not like? Lower scores indicate higher treatment utilization and acceptability. Scores range from 6-30.
Time frame: 7 Week
Average Number of Participants Successfully Randomized Per Month Over the Entirety of the Study
The purpose of this outcome is to measure feasibility across the entirety of successful recruitment and randomization.
Time frame: From first to last participant approached (up to 20 months)
Final Proportion of Participants Who Completed Follow-ups
The proportion of participants who complete follow-ups (i.e., 7-week, 6 months) will be used to evaluate feasibility of retaining the target sample (goal retention=75% or higher).
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Purpose
PREVENTION
Masking
TRIPLE
Enrollment
75
Time frame: 7 Weeks Follow Up, 6 Month Follow Up (up to 7 months)
Unexpected Adverse Events by Event
Investigators will examine whether unexpected adverse events occur throughout each participant's participation in the study.
Time frame: up to approximately 7 months