Testing of a Mobile Web App to Decrease Posttraumatic Stress Symptoms in Women After Sexual Assault
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Web App
Sponsored by
About this trial
This is an interventional prevention trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Anxiety Sensitivity, Chronic Pain, Sexual Assault
Eligibility Criteria
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
Sites / Locations
- UCHealth Memorial Central Hospital
- University of North Carolina at Chapel Hill, SANE Program
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
App Intervention
Arm Description
All participants will receive the web app for prevention of posttraumatic stress.
Outcomes
Primary Outcome Measures
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 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 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 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 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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04334356
First Posted
April 1, 2020
Last Updated
February 20, 2023
Sponsor
University of North Carolina, Chapel Hill
1. Study Identification
Unique Protocol Identification Number
NCT04334356
Brief Title
Testing of a Mobile Web App to Decrease Posttraumatic Stress Symptoms in Women After Sexual Assault
Official Title
Pilot Testing of a Mobile Web App to Mitigate Posttraumatic Stress Symptoms (PTSS) After Sexual Assault
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 30, 2020 (Actual)
Primary Completion Date
November 18, 2022 (Actual)
Study Completion Date
November 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic Stress Disorder, Anxiety Sensitivity, Chronic Pain, Sexual Assault
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In this pilot study, all participants will receive the active web app intervention.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
App Intervention
Arm Type
Experimental
Arm Description
All participants will receive the web app for prevention of posttraumatic stress.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Web App
Intervention Description
App for preventing development of posttraumatic stress based on cognitive behavioral techniques.
Primary Outcome Measure Information:
Title
Change from Week 6 to Month 6 in PCL-5 Scores
Description
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.
Time Frame
change from six weeks and six months
Title
Change from Week 6 to Month 6 in PROMIS Anxiety Scores
Description
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.
Time Frame
change from six weeks, and six months
Title
Change from Baseline to Week 6 in ASI Scores
Description
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.
Time Frame
change from Initial to six weeks
Title
Change from Week 6 to Month 6 in PROMIS Depression Scores
Description
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.
Time Frame
change from six weeks, and six months
Title
Change from Week 6 to Month 6 in Pain Related to Assault
Description
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.
Time Frame
change from six weeks, and six months
Secondary Outcome Measure Information:
Title
Insomnia Severity Index Scores
Description
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.
Time Frame
one week, six weeks, six months
Title
Somatic Symptoms
Description
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.
Time Frame
one week, six weeks, six months
Title
Association between Change in General Health and Anxiety Sensitivity
Description
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.
Time Frame
one week, six weeks, six months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Identifies as female/woman
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Short, PhD
Organizational Affiliation
University of Nevada, Las Vegas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Samuel McLean, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCHealth Memorial Central Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
University of North Carolina at Chapel Hill, SANE Program
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will become available 9 to 36 months following publication and will remain available for five years.
IPD Sharing Access Criteria
The investigator who proposes to use the data has IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.
Citations:
PubMed Identifier
25848562
Citation
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.
Results Reference
background
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Testing of a Mobile Web App to Decrease Posttraumatic Stress Symptoms in Women After Sexual Assault
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