The Mobile PTSD Coach App in Acute Injury Survivors

NCT03247179 | Completed DMC

• 1 other identifier: PRO16010595
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Pain; Acute Pain Due to Trauma; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist for DSM 5 (Diagnostic and Statistical Manual for Mental Disorders-5)

  PTSD symptoms

  past 30-days

Secondary Outcomes (2)

• Short Form of the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale

  7-days

• Short Form of the PROMIS Pain Intensity Scale

  7-days

Study Arms (2)

PTSD Coach Condition

EXPERIMENTAL

PTSD Coach App

Other: PTSD Coach mobile application

Treatment as Usual Condition

NO INTERVENTION

Treatment as Usual

Interventions

PTSD Coach mobile application OTHER

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.

PTSD Coach Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Palo Alto Veterans Institute for Research: collaborator

Study Sites (2)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Related Publications (3)

• Pacella-LaBarbara ML, Plaitano EG, Suffoletto BP, Kuhn E, Germain A, Jaramillo S, Repine M, Callaway CW. A longitudinal assessment of posttraumatic stress symptoms and pain catastrophizing after injury. Rehabil Psychol. 2023 Feb;68(1):32-42. doi: 10.1037/rep0000481.

  PMID: 36821344 DERIVED

• Brienza A, Suffoletto BP, Kuhn E, Germain A, Jaramillo S, Repine M, Callaway CW, Pacella-LaBarbara ML. The role of specific sources of social support on postinjury psychological symptoms. Rehabil Psychol. 2021 Nov;66(4):600-610. doi: 10.1037/rep0000388. Epub 2021 Aug 16.

  PMID: 34398631 DERIVED

• Pacella-LaBarbara ML, Suffoletto BP, Kuhn E, Germain A, Jaramillo S, Repine M, Callaway CW. A Pilot Randomized Controlled Trial of the PTSD Coach App Following Motor Vehicle Crash-related Injury. Acad Emerg Med. 2020 Nov;27(11):1126-1139. doi: 10.1111/acem.14000. Epub 2020 May 19.

  PMID: 32339359 DERIVED

MeSH Terms

Conditions

Chronic Pain; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria L Pacella, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: Participants will be randomly assigned to either the experimental condition (PTSD Coach app usage), or the treatment as usual condition.

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 11, 2017
• Study Start: September 19, 2017
• Primary Completion: December 20, 2018
• Study Completion: February 15, 2019
• Last Updated: March 4, 2019

Record last verified: 2019-03

Locations

US (2)