Pilot Testing of a Mobile Web App to Mitigate Posttraumatic Stress Symptoms (PTSS) After Sexual Assault
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change from Week 6 to Month 6 in PCL-5 Scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Present for emergency care within 72 hours of sexual assault
- •Receive a sexual assault nurse examiner (SANE) exam
- •Alert and oriented
排除标准
- •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
研究组 & 干预措施
App Intervention
All participants will receive the web app for prevention of posttraumatic stress.
干预措施: Mobile Web App (Behavioral)
结局指标
主要结局
Change from Week 6 to Month 6 in PCL-5 Scores
时间窗: change from six weeks and six months
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 Week 6 to Month 6 in PROMIS Anxiety Scores
时间窗: change from six weeks, and six months
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 Baseline to Week 6 in ASI Scores
时间窗: change from Initial to six weeks
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 Week 6 to Month 6 in PROMIS Depression Scores
时间窗: change from six weeks, and six months
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 Week 6 to Month 6 in Pain Related to Assault
时间窗: change from six weeks, and six months
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.
次要结局
- Insomnia Severity Index Scores(one week, six weeks, six months)
- Somatic Symptoms(one week, six weeks, six months)
- Association between Change in General Health and Anxiety Sensitivity(one week, six weeks, six months)