Posttraumatic Stress Disorder, Sexual Assault, Pain
Conditions
Keywords
Clinical Trials, Randomized, Prevention, eHealth, Anxiety Sensitivity
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.
Interventions
DEVICERISE Guide
Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress.
DEVICERelaxation Control
Guides users through relaxation techniques.
Sponsors
Mayday Fund
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, 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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Adherence/Acceptability Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Credibility/Expectancy Questionnaire | 7 Week | 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. |
| Treatment Utilization and Acceptability | 7 Week | 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. |
| Average Number of Participants Successfully Randomized Per Month Over the Entirety of the Study | From first to last participant approached (up to 20 months) | The purpose of this outcome is to measure feasibility across the entirety of successful recruitment and randomization. |
| Final Proportion of Participants Who Completed Follow-ups | 7 Weeks Follow Up, 6 Month Follow Up (up to 7 months) | 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). |
| Unexpected Adverse Events by Event | up to approximately 7 months | Investigators will examine whether unexpected adverse events occur throughout each participant's participation in the study. |
Countries
United States
Participant flow
Pre-assignment details
Of the 75 participants who signed informed consent, only 60 completed the required one-week follow up and were randomly assigned to a treatment intervention.
Participants by arm
| Arm | Count |
|---|---|
| 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.
RISE Guide: Smartphone-based intervention that uses Cognitive Bias Modification to change perceptions of stress. | 27 |
| 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.
Relaxation Control: Guides users through relaxation techniques. | 33 |
| Total | 60 |
Baseline characteristics
| Characteristic | RISE Guide | Total | Relaxation Control |
|---|---|---|---|
| Age, Continuous | 25.80 years STANDARD_DEVIATION 6.9 | 25.56 years STANDARD_DEVIATION 6.7 | 25.38 years STANDARD_DEVIATION 6.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 19 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 39 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 17 Participants | 38 Participants | 21 Participants |
| Region of Enrollment United States | 27 Participants | 60 Participants | 33 Participants |
| Sex: Female, Male Female | 27 Participants | 60 Participants | 33 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 33 |
| other Total, other adverse events | 0 / 27 | 0 / 33 |
| serious Total, serious adverse events | 0 / 27 | 0 / 33 |
Outcome results
Primary
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.
Time frame: 1 Week
Population: This measure was only provided to participants in the active (RISE Guide) condition. Data are reported for all RISE Guide participants who opted to complete the TAAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RISE Guide | Treatment Adherence/Acceptability Scale | 57.53 score on a scale | Standard Deviation 7.7 |
Secondary
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.
Time frame: From first to last participant approached (up to 20 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RISE Guide | Average Number of Participants Successfully Randomized Per Month Over the Entirety of the Study | 2 Participants recruited and randomized | Standard Deviation 2.52 |
Secondary
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.
Time frame: 7 Week
Population: All data collected are reported, some were missing due to attrition. Some participants chose to opt out of certain questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RISE Guide | Credibility/Expectancy Questionnaire | 22.85 score on a scale | Standard Deviation 10.98 |
| Relaxation Control | Credibility/Expectancy Questionnaire | 18.61 score on a scale | Standard Deviation 13.37 |
Secondary
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).
Time frame: 7 Weeks Follow Up, 6 Month Follow Up (up to 7 months)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RISE Guide | Final Proportion of Participants Who Completed Follow-ups | 7 Weeks | 0.85 proportion of participants |
| RISE Guide | Final Proportion of Participants Who Completed Follow-ups | 6 Months | 0.70 proportion of participants |
| Relaxation Control | Final Proportion of Participants Who Completed Follow-ups | 7 Weeks | 0.67 proportion of participants |
| Relaxation Control | Final Proportion of Participants Who Completed Follow-ups | 6 Months | 0.52 proportion of participants |
Secondary
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.
Time frame: 7 Week
Population: All data collected are reported, some were missing due to attrition. Some participants chose to opt out of certain questionnaires.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RISE Guide | Treatment Utilization and Acceptability | 12.45 score on a scale | Standard Deviation 4.51 |
| Relaxation Control | Treatment Utilization and Acceptability | 10.89 score on a scale | Standard Deviation 6.58 |
Secondary
Unexpected Adverse Events by Event
Investigators will examine whether unexpected adverse events occur throughout each participant's participation in the study.
Time frame: up to approximately 7 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RISE Guide | Unexpected Adverse Events by Event | 0 adverse events |
| Relaxation Control | Unexpected Adverse Events by Event | 0 adverse events |