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

NCT ID: NCT04334356

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-30

Study Completion Date

2022-11-18

Brief Summary

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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.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

In this pilot study, all participants will receive the active web app intervention.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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App Intervention

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

Group Type EXPERIMENTAL

Mobile Web App

Intervention Type BEHAVIORAL

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

Interventions

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Mobile Web App

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole Short, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nevada, Las Vegas

Samuel McLean, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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UCHealth Memorial Central Hospital

Colorado Springs, Colorado, United States

Site Status

University of North Carolina at Chapel Hill, SANE Program

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25848562 (View on PubMed)

Other Identifiers

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19-3399

Identifier Type: -

Identifier Source: org_study_id

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