Testing of a Mobile Web App to Decrease Posttraumatic Stress Symptoms in Women After Sexual Assault

Study Overview
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Brief Summary
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Interventions are available to all adult women sexual assault survivors to reduce the risk of pregnancy and sexually transmitted infection, yet no interventions are provided to reduce posttraumatic stress. This pilot study tests the ability of a smartphone-based web app to prevent and reduce posttraumatic stress in women sexual assault survivors.

Official Title
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Pilot Testing of a Mobile Web App to Mitigate Posttraumatic Stress Symptoms (PTSS) After Sexual Assault

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Mobile Web App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present for emergency care within 72 hours of sexual assault Receive a sexual assault nurse examiner (SANE) exam Alert and oriented Exclusion Criteria: Unable to consent due to intoxication, serious injury preventing ability to hear, speak, or see to consent, or other causes Prisoners Pregnant women Women living with assailant who plan to continue living with assailant Women with fractures from the assault Admitted patients Women who do not have a smartphone with continuous service for the past 12 months Inability to read and speak English No mailing address SANE exam took place >72 hours ago Patient previously enrolled in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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
Intervention Model: Single Group Assignment
Interventional Model Description: In this pilot study, all participants will receive the active web app intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: App Intervention<br>All participants will receive the web app for prevention of posttraumatic stress. | Behavioral: Mobile Web App<br>* App for preventing development of posttraumatic stress based on cognitive behavioral techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Week 6 to Month 6 in PCL-5 Scores | 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. Range: 0-80. Higher scores indicate worse outcomes. The investigators will assess whether reductions in PTSD symptoms from six weeks to six months are associated with reductions in anxiety sensitivity from the initial visit to six months. Change trajectories and mean scores of PCL-5 scores will be assessed over the 6 months of study follow-up. These patterns will be compared to prior observational research conducted in the lab. | change from six weeks and six months | 
| Change from Week 6 to Month 6 in PROMIS Anxiety Scores | The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms (racing heart, dizziness) over the past seven days. Each question has five response options ranging in value from one to five (1=never; 2=rarely; 3=sometimes; 4=often; 5=always). To find the total raw score, sum the values of the response to each question. 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 six weeks to six months are associated with reductions in anxiety sensitivity from the initial visit to six months. Change trajectories and mean scores of PROMIS scores will be assessed over the 6 months of study follow-up. These patterns will be compared to prior observational research conducted in the lab. | change from six weeks, and six months | 
| Change from Baseline to Week 6 in ASI Scores | Anxiety Sensitivity Index-3 (ASI) is a 16-item self-report questionnaire that assesses fear of anxiety sensations. Each item is scored on a 5-point Likert scale (0 to 4) with total score ranging from a minimum of 0 to a maximum of 64 (higher scores indicate greater fear of anxiety sensations). The investigators will assess patterns of ASI scores over the 6 months of study follow-up, specifically using t-tests to test for change from intake to six weeks and six months. | change from Initial to six weeks | 
| Change from Week 6 to Month 6 in PROMIS Depression Scores | The PROMIS Depression assesses self-reported negative mood (sadness, guilt), views of self (self-criticism), and social cognition (loneliness), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose) over the past seven days. Each question has five response options ranging in value from one to five (1=never; 2=rarely; 3=sometimes; 4=often; 5=always). To find the total score, sum the values of the response to each question. 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 six weeks to six months are associated with reductions in anxiety sensitivity from the initial visit to six months. Change trajectories and mean scores of PROMIS scores will be assessed over the 6 months of study follow-up. These patterns will be compared to prior observational research conducted in the lab. | change from six weeks, and six months | 
| Change from Week 6 to Month 6 in Pain Related to Assault | Pain Severity Numeric Rating Scale and Regional Pain Scale. The pain numeric rating scale (Pain NRS) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate worse pain. Participants chose the number that best described the pain during the last week. The investigators will assess whether reductions in pain NRS from six weeks to six months are associated with reductions in anxiety sensitivity from the initial visit to six months. Change trajectories and mean scores of pain NRS scores will be assessed over the 6 months of study follow-up. These patterns will be compared to prior observational research conducted in the lab. | change from six weeks, and six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index Scores | The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire that provides a measure of insomnia severity based on several indicators (e.g., difficulty falling asleep, satisfaction with sleep, degree of impairment with daytime functioning). It has adequate internal consistency and temporal stability, has been validated against sleep diary and polysomnography data and was sensitive to change in several insomnia treatment studies. The ISI scale range is: minimum = 0, maximum = 28. Lower is considered 'better sleep', while higher is considered 'worse sleep/more insomnia'. This will be assessed at one week, six weeks, and six months to determine whether reductions in ISI from six weeks to six months are associated with reductions in anxiety sensitivity from the initial visit to six months. Change trajectories and mean scores of ISI scores will be assessed over the 6 months of study follow-up. These patterns will be compared to prior observational research conducted in the lab. | one week, six weeks, six months | 
| Somatic Symptoms | A previously used questionnaire from the investigator's lab will be used to measure somatic symptoms. This measure is a 21-item self-report measure assessing various somatic symptoms (e.g., headaches, fatigue, feeling faint, stomach distress). Items are rated on a 0-10 point scale, with total scores ranging from 0 to 210. Higher scores indicate worse symptoms. This will be assessed at one week, six weeks, and six months. The investigators will assess whether reductions in somatic symptoms from six weeks to six months are associated with reductions in anxiety sensitivity from the initial visit to six months. Change trajectories and mean scores of somatic symptoms scores will be assessed over the 6 months of study follow-up. These patterns will be compared to prior observational research conducted in the lab. | one week, six weeks, six months | 
| Association between Change in General Health and Anxiety Sensitivity | PROMIS Global Health-Physical Health Component. The PROMIS was developed by the National Institutes of Health and uses domain-specific measures to assess patient well-being. It uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. Higher scores represent poorer health status. This will be assessed at one week, six weeks, and six months. The investigators will assess whether reductions in PROMIS symptoms from six weeks to six months are associated with reductions in anxiety sensitivity from the initial visit to six months. Change trajectories and mean scores of PROMIS scores will be assessed over the 6 months of study follow-up. These patterns will be compared to prior observational research conducted in the lab. | one week, six weeks, six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress Disorder, Anxiety Sensitivity, Chronic Pain, Sexual Assault