RCT for Innovating Stress-related eHealth

NCT05305235 | Completed Results FDA Device

• 1 other identifier: 20-3494
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Posttraumatic Stress Disorder; Sexual Assault; Pain

Keywords

Clinical Trials, Randomized; Prevention; eHealth; Anxiety Sensitivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Credibility/Expectancy Questionnaire

  7 Week

• Treatment Utilization and Acceptability

  7 Week

• Average Number of Participants Successfully Randomized Per Month Over the Entirety of the Study

  From first to last participant approached (up to 20 months)

• Final Proportion of Participants Who Completed Follow-ups

  7 Weeks Follow Up, 6 Month Follow Up (up to 7 months)

• Unexpected Adverse Events by Event

  up to approximately 7 months

Study Arms (2)

RISE Guide

EXPERIMENTAL

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

Relaxation Control

ACTIVE COMPARATOR

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

Interventions

RISE Guide DEVICE

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

Also known as: RCT for Innovating Stress-related eHealth

RISE Guide

Relaxation Control DEVICE

Guides users through relaxation techniques.

Also known as: Breathe2Relax

Relaxation Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identifies as woman.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women sexual assault survivors presenting for emergency care \<72 hours post-assault at one of our study locations.
• English speakers
• + years of age
• Able to provide informed consent
• Have a smartphone with continuous service \>1 year

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Mayday Fund: collaborator

Study Sites (2)

University of North Carolina at Chapel Hill, SANE Program

Chapel Hill, North Carolina, 27599, United States

Location

Austin Stop Abuse for Everyone (SAFE)

Austin, Texas, 78760, United States

Location

Related Publications (2)

• 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.

  PMID: 25848562 BACKGROUND

• Short NA, Pezza M, Reyes LD, Black J, Serrano K, McLean SA. The role of posttraumatic stress disorder symptoms in pain severity, interference, and variability after sexual assault: An ecological momentary assessment study. J Psychopathol Clin Sci. 2025 Dec 11:10.1037/abn0001083. doi: 10.1037/abn0001083. Online ahead of print.

  PMID: 41379700 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Pain

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nicole Short, PhD
• Organization: University of North Carolina at Chapel Hill

nicole.short@unlv.edu

702-895-3305

Study Officials

• Samuel A. McLean, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Nicole A. Short, PhD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be masked to their study conditions, as branding is visible in both RISE Guide and Breathe2Relax. Moreover, the UNC Research Coordinators will not be masked to condition, as they will be responsible for tracking RISE Guide progress and managing participant payments. The Principal Investigator, Biostatistician, Site Principal Investigators, Site Research Associates, and anyone involved in data analysis will remain masked to condition until data analysis is complete; masking will be maintained through reduced data viewing privileges in REDCap.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: December 1, 2021
• Primary Completion: February 24, 2024
• Study Completion: February 24, 2024
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available 9 to 36 months following publication and will remain available for five years.
• 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.

Locations

US (2)