RCT for Innovating Stress-related eHealth

University of North Carolina, Chapel Hill75 enrolled

Overview

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

Conditions

Posttraumatic Stress Disorder Sexual Assault Pain

Interventions

RISE GuideDEVICE

Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.

Relaxation ControlDEVICE

Guides users through relaxation techniques.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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