RCT for Innovating Stress-related eHealth

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Pain; Sexual Assault
• Interventions: Device: Relaxation Control; Device: RISE Guide

• Registration Number: NCT05305235
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-03-31
• Primary Completion: 2024-02-24
• Study Completion: 2024-02-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relaxation Control	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.
RISE Guide	RISE Guide	The RISE (RCT for Innovating Stress-related eHealth) Guide is based on 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.

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline to Week 7 in Anxiety Sensitivity-3 (ASI-3) Score (Active vs. Control)	Change from Day 0 (Enrollment) to Week 7	The ASI-3 is an 18-item self-report measure of anxiety sensitivity assessing 3 subdomains of anxiety sensitivity (physical, cognitive, and social). Participants respond to items (e.g., It scares me when my heart beats rapidly) on a 5-point Likert scale (0 to 4). The total ranging from a minimum of 0 to 72 (higher scores indicate greater fear of anxiety sensations.
Mean Treatment Acceptability/Adherence Scale (TAAS) Score (Active vs. Control)	Week 1	The 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. No specific cutoff is provided for acceptability/adherence, but higher scores are considered to be more acceptable and more likely to be maintained by participants.
Mean Credibility/Expectability Questionnaire (CEQ) Score (Active vs. Control)	Week 1	The CEQ is a 6-item measure of treatment credibility and expectancy of treatment to improve symptoms. Items are rated on 9-to-11-point Likert scales. Higher scores indicate higher levels of acceptability. Scores \>30 indicate good acceptability.
Mean Treatment Utilization and Acceptability (TUA) Score (Active vs. Control)	Week 7	The TUA is a 6-item measure 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? The TUA does not have a clinical cut-off. Higher scores indicate higher levels of treatment utilization and acceptability.
Mean PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL-5) Score (Active vs. Control)	Day 1 through Day 49 via twice-daily flash surveys, Month 6	The Posttraumatic Stress Disorder (PTSD) Checklist (PCL-5) for Diagnostic and Statistical Manual-5 (DSM-5) is the gold standard measure of PTSD symptom severity. The measures 4 symptom clusters (re-experiencing, avoidance, negative alterations in cognition and mood, and iterations in arousal and reactivity) via 19 items. Items correspond to each DSM-5 symptom of PTSD on a 5-point Likert scale. Scores range: 0-80. Higher scores indicate worse outcomes.
Percent of Participant above Clinically-Significant Cut-off for Drug Abuse Screening Test (DAST; Active vs. Control)	Month 6	The DAST is a 10-item self-reported yes/no checklist of various problems related to drug use (e.g., withdrawal symptoms, neglecting family duties, medical problems as a consequence of drug use). The total ranging from 0 to 10 and the higher the score indicates severe problems related to drug use.

Secondary Outcome Measures

Name	Time	Method
Mean Fagerstrom Test of Nicotine Dependence (FTND; Active vs. Control)	Month 6	The FTND measures current cigarette smoking and symptoms of nicotine dependence using 6 items self-reported on various scales (e.g., how many cigarettes do you smoke per day, Do you find it difficult to refrain from smoking in places where it is forbidden). he items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.
Mean Alcohol Use Disorder Identification Test (AUDIT; Active vs. Control)	Month 6	AUDIT is a 10-item measure of alcohol consumption and alcohol use disorder symptoms, such as frequency and quantity of drinking and problems related to drinking. Items are rated on a 5-point scale. The minimum score is 0 and the maximum score is 40. The higher the score indicates more likelihood of alcohol dependence.
Mean Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression Score (Active vs. Control)	Initial to Month 6	PROMIS-Depression is an 8-item measure for symptoms of depression. Participants rate items on a 5-point Likert scale. The lowest raw score is 8; the highest is 40. A higher score represents more of the concept being measured. The investigators will assess whether reductions in PROMIS symptoms from 7 weeks to 6 months are associated with reductions in anxiety sensitivity from the initial visit to 6 months.
Mean Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety Score (Active vs. Control)	Initial to Month 6	PROMIS-Anxiety is a 7-item measure assessing self-reported symptoms of anxiety (e.g., anxious, worried, nervous) rated on a 5-point scale. The lowest raw score is 8; the highest raw score is 40. A higher score represents more of the concept being measured. The investigators will assess whether reductions in PROMIS symptoms from 7 weeks to 6 months are associated with reductions in anxiety sensitivity from the initial visit to 6 months.
Percent of Participant above Clinically-Significant Cut-off for Marijuana Motives Measure (MMM; Active vs. Control)	Month 6	The MMM is a 25-item self-report measure of cannabis motives looking at 5 categories for social, coping, enhancement, conformity, and expansion motives. Participants respond to a list of motives (e.g., to forget my worries, to get high) on a 5-point Likert scale ranging from 1 for "almost never/never" to 5 for "almost always/always." The mean of items in each 5 sub categories are calculated and total score is sum of means for the 5 sub-scales. The higher the score the higher motive for marijuana use.

Trial Locations

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