RCT for Innovating Stress-related eHealth

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Posttraumatic Stress Disorder, Sexual Assault

Intervention / Treatment
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* Device: RISE Guide
* Device: Relaxation Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RISE Guide<br>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. | Device: RISE Guide<br>* Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.<br>* Other names: RCT for Innovating Stress-related eHealth;|
| Active Comparator: Relaxation Control<br>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<br>* Guides users through relaxation techniques.<br>* Other names: Breathe2Relax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change from Baseline to Week 7 in Anxiety Sensitivity-3 (ASI-3) Score (Active vs. Control) | 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. | Change from Day 0 (Enrollment) to Week 7 | 
| Mean Treatment Acceptability/Adherence Scale (TAAS) Score (Active vs. Control) | 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. | Week 1 | 
| Mean Credibility/Expectability Questionnaire (CEQ) Score (Active vs. Control) | 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. | Week 1 | 
| Mean Treatment Utilization and Acceptability (TUA) Score (Active vs. Control) | 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. | Week 7 | 
| Mean PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL-5) Score (Active vs. Control) | 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. | Day 1 through Day 49 via twice-daily flash surveys, Month 6 | 
| Percent of Participant above Clinically-Significant Cut-off for Drug Abuse Screening Test (DAST; Active vs. Control) | 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. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety Score (Active vs. Control) | 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. | Initial to Month 6 | 
| Mean Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression Score (Active vs. Control) | 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. | Initial to Month 6 | 
| Mean Alcohol Use Disorder Identification Test (AUDIT; Active vs. Control) | 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. | Month 6 | 
| Mean Fagerstrom Test of Nicotine Dependence (FTND; Active vs. Control) | 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. | Month 6 | 
| Percent of Participant above Clinically-Significant Cut-off for Marijuana Motives Measure (MMM; Active vs. Control) | 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. | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical Trials, Randomized, Prevention, eHealth, Anxiety Sensitivity