The Mobile PTSD Coach App in Acute Injury Survivors

March 1, 2019 updated by: Maria Pacella, University of Pittsburgh

Secondary Prevention With the Mobile PTSD Coach App to Improve Health Outcomes and the Continuity of Care Following Traumatic Physical Injury: A Randomized Controlled Trial

This project is a preliminary randomized controlled trial testing the potential impact of the PTSD Coach mobile application at reducing posttraumatic stress and pain symptoms among acutely injured trauma patients. Immediately following the injury, patients will be randomly assigned to use the PTSD Coach app, or to the treatment as usual condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Traumatic injury is the leading cause of mortality in the U.S. for young people, and a source of long-term morbidity in all ages. A majority of trauma patients report chronic pain (CP) and disability at 4-months (30%- 79%) and 12-months (63%) post-injury. Maladaptive psychological processes have a stronger association with the transition to CP than does injury severity. Posttraumatic stress disorder (PTSD) symptoms (e.g., intrusions, avoidance and hyperarousal) occur in up to 22% of post-injury patients and herald the transition from acute to CP. Although psychological interventions can modify PTSD symptoms, and reduce CP, it is unknown if early intervention to prevent PTSD symptoms can prevent post-injury CP altogether. "PTSD Coach" is a publicly available, free, mobile app that provides scalable and psychosocial support modeled on principles of cognitive-behavioral therapy. PTSD Coach has helped Veterans and civilians to manage PTSD.

This project will test whether PTSD Coach can reduce post-injury maladaptive psychological processes and thereby prevent post-injury CP. The preventive intervention will be targeted towards those at the highest-risk of developing PTSD.

The investigators propose to test the efficacy of the PTSD Coach app vs. treatment as usual (TAU) among a sample of acute physical injury patients, to: 1) Determine engagement with PTSD Coach, by measuring frequency of use over 4-weeks and assessing ratings of usefulness and qualitative feedback: it is expected that >80% of PTSD Coach users will use the app at least once a week, and will rate it as at least somewhat helpful; 2) Estimate effect on CP symptoms by measuring PTSD and pain intensity at 1- and 3-months. The effect of the intervention on pain interference, disability, and coping self-efficacy will also be explored.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital
      • Pittsburgh, Pennsylvania, United States, 15219
        • UPMC Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • English-speaking adults seeking treatment in the ED
  • Adults between the ages of 18-65
  • Sustained a musculoskeletal injury (e.g., fractures, sprains or strains, contusions, dislocations, crushing injuries and open wounds; and other chief complains involving the neck, back, or extremities)
  • Injury resulting from a motor vehicle crash (MVC) or motorcycle crash (MCC) that occurred within the past 24 hours
  • Eligible patients must own a mobile phone with short-message service (SMS) features (e.g., the ability to send and respond to text messages) and the ability to download apps
  • Participants must self-report that they experienced a potential traumatic event reflected by Criterion A of the DSM-5 PTSD diagnosis (endorse actual or perceived life threat and/or serious injury141,142)
  • Participants must self-report that they experienced a painful injury reflected by a pain score ≥4 using the verbal numerical score (0-10) in response to the question: "On a scale of 0-10, how severe is your pain?"
  • Patients with a past history of PTSD, but not currently receiving treatment (e.g., benzodiazepines or mental/behavioral therapy), are eligible for participation.

Exclusion Criteria:

  • Presenting to the ED for a non-MVC/MCC (i.e., fall, assault)
  • Participants who do not own a mobile phone with SMS features
  • Participants with a pain score < 4 or do not endorse Criterion A of the DSM-5 PTSD diagnosis
  • Spinal injuries
  • Major lacerations resulting in significant damage to subcutaneous tissue (e.g., degloving) and specific nerve injury (these injuries could lead to a distinct neuropathic pain syndrome)
  • Traumatic brain injury; Evidence of moderate to severe cognitive impairment secondary to trauma-related head injury (GCS<13)
  • Self-inflicted injury
  • Time since trauma > 24 hours
  • Non-English speaking; younger than 18 or older than 65
  • Not medically stable or alert and oriented
  • Initiation of benzodiazepines and other psychotropic medications at time of ED visit
  • Initiation of mental or behavioral health therapy at time of ED visit
  • Currently enrolled in treatment (medication or mental/behavioral health therapy) for PTSD
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PTSD Coach Condition
PTSD Coach App
Other: PTSD Coach mobile application
The PTSD Coach app is publicly available for free, and draws on cognitive behavioral therapy components to help participants learn, manage, and cope with their PTSD symptoms in real time.
No Intervention: Treatment as Usual Condition
Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Checklist for DSM 5 (Diagnostic and Statistical Manual for Mental Disorders-5)
Time Frame: past 30-days
PTSD symptoms
past 30-days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form of the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale
Time Frame: 7-days
8-items assessing pain interference
7-days
Short Form of the PROMIS Pain Intensity Scale
Time Frame: 7-days
3-items assessing pain intensity
7-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Palo Alto Veterans Institute for Research

Investigators

  • Principal Investigator: Maria L Pacella, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2017

Primary Completion (Actual)

December 20, 2018

Study Completion (Actual)

February 15, 2019

Study Registration Dates

First Submitted

August 8, 2017

First Submitted That Met QC Criteria

August 8, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

March 4, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO16010595

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

There is no plan in place yet because it is undecided whether the research team will need to share the data with investigators/researchers not listed on the protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on PTSD Coach mobile application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe