RCT for Innovating Stress-related eHealth

NCT ID: NCT05305235

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2024-02-24

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.

Conditions

Posttraumatic Stress Disorder; Sexual Assault; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

RISE Guide

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Relaxation Control

Intervention Type: DEVICE

Guides users through relaxation techniques.

Interventions

RISE Guide

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

Intervention Type: DEVICE

Relaxation Control

Guides users through relaxation techniques.

Intervention Type: DEVICE

Other Intervention Names

RCT for Innovating Stress-related eHealth; Breathe2Relax

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mayday Fund

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel A. McLean, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Nicole A. Short, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nevada, Las Vegas

Locations

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25848562 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-3494

Identifier Type: -

Identifier Source: org_study_id