Clinical trial NCT05305235: RCT for Innovating Stress-related eHealth
Official title: Development of a Digital Therapeutic Targeting Anxiety Sensitivity to Reduce Posttraumatic Stress in Women Presenting for Emergency Care After Sexual Assault
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Sexual Assault
Pain
Keywords: Clinical Trials, Randomized
Prevention
eHealth
Anxiety Sensitivity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Mayday Fund
First posted: 2022-03-31
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization tables will be generated by the study Biostatistician and uploaded into the study REDCap database by a UNC Research Coordinator prior to launching data collection. Participants are randomized (1:1) to receive either the RISE Guide (experimental) condition or Breathe2Relax (control) condition after completing their 1-week survey. The list of assignments will be stored securely in REDCap.
Primary purpose: PREVENTION

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 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

Primary outcomes:
measure: Treatment Adherence/Acceptability Scale
timeFrame: 1 Week
Secondary outcomes:
measure: Credibility/Expectancy Questionnaire
timeFrame: 7 Week
measure: Treatment Utilization and Acceptability
timeFrame: 7 Week
measure: Average Number of Participants Successfully Randomized Per Month Over the Entirety of the Study
timeFrame: From first to last participant approached (up to 20 months)
measure: Final Proportion of Participants Who Completed Follow-ups
timeFrame: 7 Weeks Follow Up, 6 Month Follow Up (up to 7 months)
measure: Unexpected Adverse Events by Event
timeFrame: up to approximately 7 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, SANE Program
state: North Carolina
city: Austin
country: United States
facility: Austin Stop Abuse for Everyone (SAFE)
state: Texas
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Samuel A. McLean, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nevada, Las Vegas
name: Nicole A. Short, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Broderick JE, DeWitt EM, Rothrock N, Crane PK, Forrest CB. Advances in Patient-Reported Outcomes: The NIH PROMIS((R)) Measures. EGEMS (Wash DC). 2013 Aug 2;1(1):1015. doi: 10.13063/2327-9214.1015. eCollection 2013.