RCT for Innovating Stress-related eHealth (RISE)

University of North Carolina (UNC)

Status: Completed

Conditions: Posttraumatic Stress Disorder; Sexual Assault; Pain

Treatments: Device: Relaxation Control; Device: RISE Guide

Study type: Interventional

Funder types: Other

Identifiers

NCT05305235

20-3494

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 2 patient groups

RISE Guide

Experimental group

Description:

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.

Treatment:

Device: RISE Guide

Relaxation Control

Active Comparator group

Description:

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.

Treatment:

Device: Relaxation Control