RCT for Innovating Stress-related eHealth (RISE)

• ClinicalTrials.gov Identifier: NCT05305235
• Recruitment Status: Recruiting
• First Posted: March 31, 2022
• Last Update Posted: November 2, 2022
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Mayday Fund
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Posttraumatic Stress Disorder; Sexual Assault; Pain	Device: RISE Guide; Device: Relaxation Control	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: Development of a Digital Therapeutic Targeting Anxiety Sensitivity to Reduce Posttraumatic Stress in Women Presenting for Emergency Care After Sexual Assault
• Actual Study Start Date: December 1, 2021
• Estimated Primary Completion Date: October 2026
• Estimated Study Completion Date: October 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: RISE Guide; Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.; Other Name: RCT for Innovating Stress-related eHealth
Active Comparator: 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.	Device: Relaxation Control; Guides users through relaxation techniques.; Other Name: Breathe2Relax

Outcome Measures

Primary Outcome Measures :

1. Mean Change from Baseline to Week 7 in Anxiety Sensitivity-3 (ASI-3) Score (Active vs. Control) [ Time Frame: 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.
2. Mean Treatment Acceptability/Adherence Scale (TAAS) Score (Active vs. Control) [ Time Frame: 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.
3. Mean Credibility/Expectability Questionnaire (CEQ) Score (Active vs. Control) [ Time Frame: 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.
4. Mean Treatment Utilization and Acceptability (TUA) Score (Active vs. Control) [ Time Frame: 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.
5. Mean PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL-5) Score (Active vs. Control) [ Time Frame: Day 1 through Day 49 via twice-daily flash surveys, Month 6, Month 12 ]
   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.
6. Percent of Participant above Clinically-Significant Cut-off for Drug Abuse Screening Test (DAST; Active vs. Control) [ Time Frame: Month 6, Month 12 ]
   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 :

1. Mean Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety Score (Active vs. Control) [ Time Frame: Initial to Month 12 ]
   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 12 months are associated with reductions in anxiety sensitivity from the initial visit to 12 months.
2. Mean Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression Score (Active vs. Control) [ Time Frame: Initial to Month 12 ]
   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 12 months are associated with reductions in anxiety sensitivity from the initial visit to 12 months.
3. Mean Alcohol Use Disorder Identification Test (AUDIT; Active vs. Control) [ Time Frame: Month 6, Month 12 ]
   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.
4. Mean Fagerstrom Test of Nicotine Dependence (FTND; Active vs. Control) [ Time Frame: Month 6, Month 12 ]
   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.
5. Percent of Participant above Clinically-Significant Cut-off for Marijuana Motives Measure (MMM; Active vs. Control) [ Time Frame: Month 6, Month 12 ]
   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.

Other Outcome Measures:

1. Percent of Participants above Clinically-Significant Cut-off for Marijuana Problems Scale (MPS; Active vs. Control) [ Time Frame: [Time Frame: Month 6, Month 12] ]
   The MPS is a 19-item self-report measure of problems related to cannabis use (e.g., problems with work, school, social functioning). Participants rate items on a 3-point Likert scale. There are two scores calculated, a total summed score of the severity ratings (MPS-severity, 0-38) and a total problem score (MPS-number, the number of items scored minor or serious, 0-19).
2. Percent of Participant above Clinically-Significant Cut-off for Composite International Diagnostic Interview Screening Scales (CIDI-SC) [ Time Frame: Month 6, Month 12 ]
   The CIDI-SC is a screening measure of substance use, and assesses for frequency of substance use, including cannabis use. There is no clinical cut-off for the CIDI-SC measure. Higher scores indicate more frequent use of substances.
3. Mean Cannabis Use and Frequency Score (Active vs. Control) [ Time Frame: Day 1 through Day 49 via daily flash surveys ]
   Ecological momentary assessment will include self-report measures of whether cannabis was used that day (yes/no) and, if so, quantity used on an 8-point scale, assessed 1x/day over the first 7 weeks. These measures do not have a clinical cut-off and individual scores of Average Use and Frequency of Use are computed. Higher scores indicate higher mean cannabis use quantity (average per day) and frequency (average days used per week).
4. Mean Marijuana Cravings Questionnaire-Emotionality (MCQ) Score (Active vs. Control) [ Time Frame: Day 1 through Day 49 via twice-daily flash surveys ]
   The MCQ is a 12-item measure of state cannabis cravings. In the current study, the emotionality subscale will be used in the initial visit and in ecological momentary assessments provided 2x/day in the 7 weeks post-trauma. Participants rate each item on a 7-point visual analog scale. The MCQ does not have clinical cut-offs. Higher scores indicate higher levels of state cannabis cravings.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Identifies as woman.
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Kristen D. Witkemper, MPH; 919-966-8144; kristen_witkemper@med.unc.edu

Contact: Nicole A. Short, PhD; 919-843-0045; nicole.short@unlv.edu

Locations

United States, North Carolina

University of North Carolina at Chapel Hill, SANE Program; Recruiting

Chapel Hill, North Carolina, United States, 27599

Contact: Karen D. Serrano, MD 919-966-6442 kserrano@email.unc.edu

Contact: Jenny Anand, MPH, BSN 984-215-3078 jenny.anand@unchealth.unc.edu

Principal Investigator: Karen D. Serrano, MD

United States, Texas

Austin Stop Abuse for Everyone (SAFE); Recruiting

Austin, Texas, United States, 78760

Contact: Jenny Black, BSN 512-356-1530 jblack@safeaustin.org

Contact: Ix Chel Morrison 512-356 1576 imorrison@safeaustin.org

Principal Investigator: Jenny Black, BSN

Sponsors and Collaborators

University of North Carolina, Chapel Hill

Mayday Fund

Investigators

• Principal Investigator: Samuel A. McLean, MD, MPH; University of North Carolina, Chapel Hill
• Principal Investigator: Nicole A. Short, PhD; University of Nevada, Las Vegas

More Information

Publications:

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.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT05305235
• Other Study ID Numbers: 20-3494
• First Posted: March 31, 2022
• Last Update Posted: November 2, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Deidentified individual data that supports the results will be shared by reasonable request beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of North Carolina, Chapel Hill:

Clinical Trials, Randomized; Prevention; eHealth; Anxiety Sensitivity

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders