Clinical trial NCT04334356: 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
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
Anxiety Sensitivity
Chronic Pain
Sexual Assault
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In this pilot study, all participants will receive the active web app intervention.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change from Week 6 to Month 6 in PCL-5 Scores
timeFrame: change from six weeks and six months
measure: Change from Week 6 to Month 6 in PROMIS Anxiety Scores
timeFrame: change from six weeks, and six months
measure: Change from Baseline to Week 6 in ASI Scores
timeFrame: change from Initial to six weeks
measure: Change from Week 6 to Month 6 in PROMIS Depression Scores
timeFrame: change from six weeks, and six months
measure: Change from Week 6 to Month 6 in Pain Related to Assault
timeFrame: change from six weeks, and six months
Secondary outcomes:
measure: Insomnia Severity Index Scores
timeFrame: one week, six weeks, six months
measure: Somatic Symptoms
timeFrame: one week, six weeks, six months
measure: Association between Change in General Health and Anxiety Sensitivity
timeFrame: one week, six weeks, six months
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: UCHealth Memorial Central Hospital
state: Colorado
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill, SANE Program
state: North Carolina
Study officials:
affiliation: University of Nevada, Las Vegas
name: Nicole Short, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Samuel McLean, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.