Skip to main content
OpenTrials
Completed

NCT Number: NCT04334356

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCHealth Memorial Central Hospital, Colorado Springs, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Web App

Behavioral

App for preventing development of posttraumatic stress based on cognitive behavioral techniques.

Primary outcomes

  1. Change from Week 6 to Month 6 in PCL-5 Scores

    Time frame: 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.

  2. Change from Week 6 to Month 6 in PROMIS Anxiety Scores

    Time frame: 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.

  3. Change from Baseline to Week 6 in ASI Scores

    Time frame: 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.

  4. Change from Week 6 to Month 6 in PROMIS Depression Scores

    Time frame: 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.

  5. Change from Week 6 to Month 6 in Pain Related to Assault

    Time frame: 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.

Secondary outcomes

  1. Insomnia Severity Index Scores

    Time frame: one week, six weeks, six months

    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.

  2. Somatic Symptoms

    Time frame: one week, six weeks, six months

    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.

  3. Association between Change in General Health and Anxiety Sensitivity

    Time frame: one week, six weeks, six months

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2020
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.