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

NCT04334356 | Completed

• 1 other identifier: 19-3399
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Anxiety Sensitivity; Chronic Pain; Sexual Assault

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• 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

Study Arms (1)

App Intervention

EXPERIMENTAL

All participants will receive the web app for prevention of posttraumatic stress.

Behavioral: Mobile Web App

Interventions

Mobile Web App BEHAVIORAL

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

App Intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: Identifies as female/woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Present for emergency care within 72 hours of sexual assault
• Receive a sexual assault nurse examiner (SANE) exam
• Alert and oriented

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (2)

UCHealth Memorial Central Hospital

Colorado Springs, Colorado, 80909, United States

Location

University of North Carolina at Chapel Hill, SANE Program

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• 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.

  PMID: 25848562 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Chronic Pain

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicole Short, PhD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

• Samuel McLean, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this pilot study, all participants will receive the active web app intervention.

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 6, 2020
• Study Start: May 30, 2020
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: February 21, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available 9 to 36 months following publication and will remain available for five years.
• 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.

Locations

US (2)