RCT for Innovating Stress-related eHealth

Pain Clinical Trial

— RISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305235
• Other study ID #: 20-3494
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: February 24, 2024

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 24, 2024
• Est. primary completion date: February 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Posttraumatic Stress Disorder
• Sexual Assault
• Stress Disorders, Post-Traumatic

Intervention

Device:
• RISE Guide
Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.
• Relaxation Control
Guides users through relaxation techniques.

Locations

Country	Name	City	State
United States	Austin Stop Abuse for Everyone (SAFE)	Austin	Texas
United States	University of North Carolina at Chapel Hill, SANE Program	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Mayday Fund

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent of Participants above Clinically-Significant Cut-off for Marijuana Problems Scale (MPS; Active vs. Control)	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).	Month 6
Other	Percent of Participant above Clinically-Significant Cut-off for Composite International Diagnostic Interview Screening Scales (CIDI-SC)	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.	Month 6
Other	Mean Cannabis Use and Frequency Score (Active vs. Control)	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).	Day 1 through Day 49 via daily flash surveys
Other	Mean Marijuana Cravings Questionnaire-Emotionality (MCQ) Score (Active vs. Control)	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.	Day 1 through Day 49 via twice-daily flash surveys
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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