Posttraumatic Stress DisorderRISENCT05305235
RCT for Innovating Stress-related eHealth
A study testing RISE Guide in people with Posttraumatic Stress Disorder and Sexual Assault, run by University of North Carolina, Chapel Hill at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Sexual Assault, Pain
- What is being tested?
- RISE Guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2021to 24 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Austin Stop Abuse for Everyone (SAFE)
Austin, Texas, 78760
University of North Carolina at Chapel Hill, SANE Program
Chapel Hill, North Carolina, 27599
About this study
Official title: Development of a Digital Therapeutic Targeting Anxiety Sensitivity to Reduce Posttraumatic Stress in Women Presenting for Emergency Care After Sexual Assault
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder, Sexual Assault, Pain
- Being tested
- RISE Guide, Relaxation Control
- Keywords
- Clinical Trials, Randomized, Prevention, eHealth, Anxiety Sensitivity
- Medical subject headings
- Stress Disorders, Post-Traumatic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISE GuideDevice
Also called RCT for Innovating Stress-related eHealth
Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.
Relaxation ControlDevice
Also called Breathe2Relax
Guides users through relaxation techniques.
| Study group | Role | What they receive |
|---|---|---|
| RISE Guide | Experimental | 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. Receives: Device: RISE Guide |
| Relaxation Control | Active comparator | 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. Receives: Device: Relaxation Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Adherence/Acceptability Scale
The Treatment Adherence/Acceptability Scale (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 with scores ranging from 10-70. Higher scores indicate higher acceptability.
Measured: 1 Week
Secondary outcomes (5)
Credibility/Expectancy Questionnaire
Credibility/Expectancy Questionnaire (CEQ; 1 week) 6-item measure of treatment credibility and expectancy of treatment to improve symptoms. Items are rated on 9-to-11-point Likert scales. 11-point scales (0-100% in 10% intervals are recoded to align with the 1-9 scales). Higher scores indicate higher credibility/expectancy. Scores can range from 4 to 56.
Measured: 7 Week
Treatment Utilization and Acceptability
6 items self-report survey 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? Lower scores indicate higher treatment utilization and acceptability. Scores range from 6-30.
Measured: 7 Week
Average Number of Participants Successfully Randomized Per Month Over the Entirety of the Study
The purpose of this outcome is to measure feasibility across the entirety of successful recruitment and randomization.
Measured: From first to last participant approached (up to 20 months)
Final Proportion of Participants Who Completed Follow-ups
The proportion of participants who complete follow-ups (i.e., 7-week, 6 months) will be used to evaluate feasibility of retaining the target sample (goal retention=75% or higher).
Measured: 7 Weeks Follow Up, 6 Month Follow Up (up to 7 months)
Unexpected Adverse Events by Event
Investigators will examine whether unexpected adverse events occur throughout each participant's participation in the study.
Measured: up to approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Dec 2021
- Primary completion24 Feb 2024
- Study completion24 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Mayday Fund
- Responsible party
- Sponsor
- Investigators
- Samuel A. McLean, MD, MPH, Principal investigator, University of North Carolina, Chapel HillNicole A. Short, PhD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305235
- Sponsor's protocol ID
- 20-3494
- Acronym
- RISE
- Status last verified
- Feb 2025
- First submitted
- 22 Mar 2022
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
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.
PubMed 25848562Short NA, Deguzman-Lucero R, Weese R, Chisam N, Black J, Serrano K, McLean S. Testing a Smartphone-Based Intervention Targeting Anxiety Sensitivity Among Women Presenting for Emergency Care After Sexual Assault: Pilot Randomized Controlled Trial. JMIR Form Res. 2026 May 25;10:e86612. doi: 10.2196/86612.
PubMed 42186353Short NA, Pezza M, Reyes LD, Black J, Serrano K, McLean SA. The role of posttraumatic stress disorder symptoms in pain severity, interference, and variability after sexual assault: An ecological momentary assessment study. J Psychopathol Clin Sci. 2026 Aug;135(6):785-795. doi: 10.1037/abn0001083. Epub 2025 Dec 11.
PubMed 41379700
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Digital Therapeutic Targeting Anxiety Sensitivity to Reduce Posttraumatic Stress in Women Presenting for Emergency Care After Sexual Assault
- ClinicalTrials.gov ID
- NCT05305235
- Acronym / sponsor ID
- RISE / 20-3494
- Conditions
- Posttraumatic Stress Disorder, Sexual Assault, Pain
- Keywords
- Clinical Trials, Randomized, Prevention, eHealth, Anxiety Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Mayday Fund
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 24 Feb 2024 (actual)
- Study completion
- 24 Feb 2024 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Posted 5 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| RISE Guide | Experimental | Device: RISE GuideThe 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. |
| Relaxation Control | Active comparator | Device: Relaxation ControlBreathe2Relax 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RISE GuideAlso: RCT for Innovating Stress-related eHealthSmartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress. | Device | RISE Guide |
| Relaxation ControlAlso: Breathe2RelaxGuides users through relaxation techniques. | Device | Relaxation Control |
Primary outcome
Treatment Adherence/Acceptability Scale
Time frame: 1 Week
The Treatment Adherence/Acceptability Scale (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 with scores ranging from 10-70. Higher scores indicate higher acceptability.
5 secondary outcomes
Credibility/Expectancy Questionnaire
Time frame: 7 Week
Treatment Utilization and Acceptability
Time frame: 7 Week
Average Number of Participants Successfully Randomized Per Month Over the Entirety of the Study
Time frame: From first to last participant approached (up to 20 months)
Final Proportion of Participants Who Completed Follow-ups
Time frame: 7 Weeks Follow Up, 6 Month Follow Up (up to 7 months)
Unexpected Adverse Events by Event
Time frame: up to approximately 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25848562Broderick 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.
- Derived from this study: PubMed 42186353Short NA, Deguzman-Lucero R, Weese R, Chisam N, Black J, Serrano K, McLean S. Testing a Smartphone-Based Intervention Targeting Anxiety Sensitivity Among Women Presenting for Emergency Care After Sexual Assault: Pilot Randomized Controlled Trial. JMIR Form Res. 2026 May 25;10:e86612. doi: 10.2196/86612.
- Derived from this study: PubMed 41379700Short NA, Pezza M, Reyes LD, Black J, Serrano K, McLean SA. The role of posttraumatic stress disorder symptoms in pain severity, interference, and variability after sexual assault: An ecological momentary assessment study. J Psychopathol Clin Sci. 2026 Aug;135(6):785-795. doi: 10.1037/abn0001083. Epub 2025 Dec 11.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Posttraumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel A. McLean, MD, MPH principal investigator
University of North Carolina, Chapel Hill
Nicole A. Short, PhD principal investigator
University of Nevada, Las Vegas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RISE Guide in people with Posttraumatic Stress Disorder and Sexual Assault, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Adherence/Acceptability Scale (time frame: 1 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05305235, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.