RCT for Innovating Stress-related eHealth (RISE)

Development of a Digital Therapeutic Targeting Anxiety Sensitivity to Reduce Posttraumatic Stress in Women Presenting for Emergency Care After Sexual Assault

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.

Study Overview

• Status: Completed
• Conditions: Pain; Posttraumatic Stress Disorder; Sexual Assault
• Intervention / Treatment: Device: RISE Guide; Device: Relaxation Control

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill, SANE Program
  • Texas
    • Austin, Texas, United States, 78760
      • Austin Stop Abuse for Everyone (SAFE)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Relaxation Control; Breathe2Relax is a mobile application that instructs users on diaphragmatic breathing, a coping tool in which slow breathing through the diaphragm reduces anxiety. Participants in the control condition will download Breathe2Relax to their smartphones and receive short message service (SMS) reminders to engage with the app. The control intervention is expected to reduce symptoms, but not as much as the cognitive-behavioral therapy strategies taught in RISE Guide.	Device: Relaxation Control; Guides users through relaxation techniques.; Other Names: Breathe2Relax
Experimental: RISE Guide; The RISE (RCT for Innovating Stress-related eHealth) Guide is based on Cognitive Anxiety Sensitivity Treatment (CAST), an anxiety sensitivity intervention effective in reducing anxiety sensitivity, posttraumatic stress, depression, and anxiety. RISE Guide delivers psychoeducation and cognitive-behavioral therapy principles in an interactive, audio-visual format discussing the stress response, myth-busting cognitive distortions related to stress, and facilitating safe exposure to feared sensations. Participants then complete a validated cognitive bias modification (CBM-I) for interpretation biases related to anxiety sensitivity. Finally, intervention principles are reinforced using ecological momentary intervention (EMI), in which surveys and personalized reminders are delivered based on symptoms reported during ecological momentary assessments (EMAs) RISE Guide delivered by smartphone via Qualtrics and is completed in ~45 minutes over 2 weeks, with EMI weeks 1-7 post-assault.	Device: RISE Guide; Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.; Other Names: RCT for Innovating Stress-related eHealth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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).	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.	up to approximately 7 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Cannabis Use and Frequency Score (Active vs. Control)	Ecological momentary assessment will include self-report measures of whether cannabis was used that day (yes/no) and, if so, quantity used on an 8-point scale, assessed 1x/day over the first 7 weeks. These measures do not have a clinical cut-off and individual scores of Average Use and Frequency of Use are computed. Higher scores indicate higher mean cannabis use quantity (average per day) and frequency (average days used per week).	Day 1 through Day 49 via daily flash surveys
Mean Marijuana Cravings Questionnaire-Emotionality (MCQ) Score (Active vs. Control)	The MCQ is a 12-item measure of state cannabis cravings. In the current study, the emotionality subscale will be used in the initial visit and in ecological momentary assessments provided 2x/day in the 7 weeks post-trauma. Participants rate each item on a 7-point visual analog scale. The MCQ does not have clinical cut-offs. Higher scores indicate higher levels of state cannabis cravings.	Day 1 through Day 49 via twice-daily flash surveys
Percent of Participants above Clinically-Significant Cut-off for Marijuana Problems Scale (MPS; Active vs. Control)	The MPS is a 19-item self-report measure of problems related to cannabis use (e.g., problems with work, school, social functioning). Participants rate items on a 3-point Likert scale. There are two scores calculated, a total summed score of the severity ratings (MPS-severity, 0-38) and a total problem score (MPS-number, the number of items scored minor or serious, 0-19).	Month 6
Percent of Participant above Clinically-Significant Cut-off for Composite International Diagnostic Interview Screening Scales (CIDI-SC)	The CIDI-SC is a screening measure of substance use, and assesses for frequency of substance use, including cannabis use. There is no clinical cut-off for the CIDI-SC measure. Higher scores indicate more frequent use of substances.	Month 6

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Mayday Fund
• Investigators: Principal Investigator: Samuel A. McLean, MD, MPH, University of North Carolina, Chapel Hill; Principal Investigator: Nicole A. Short, PhD, University of Nevada, Las Vegas

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): February 24, 2024
• Study Completion (Actual): February 24, 2024

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Prevention; eHealth; Clinical Trials, Randomized; Anxiety Sensitivity
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 20-3494

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared by reasonable request beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: Data will become available 9 to 36 months following publication and will remain available for five years.
• IPD Sharing Access Criteria: The investigator who proposes to use the data has IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No