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The Mobile PTSD Coach App in Acute Injury Survivors

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PTSD Coach mobile application

About this trial

This is an interventional prevention trial for Chronic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UPMC Presbyterian Hospital
UPMC Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PTSD Coach Condition

Treatment as Usual Condition

Arm Description

PTSD Coach App

Treatment as Usual

Outcomes

Primary Outcome Measures

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

PTSD symptoms

Secondary Outcome Measures

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

8-items assessing pain interference

Short Form of the PROMIS Pain Intensity Scale

3-items assessing pain intensity

Full Information

NCT ID

NCT03247179

First Posted

August 8, 2017

Last Updated

March 1, 2019

Sponsor

University of Pittsburgh

Collaborators

Palo Alto Veterans Institute for Research

1. Study Identification

Unique Protocol Identification Number

NCT03247179

Brief Title

The Mobile PTSD Coach App in Acute Injury Survivors

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

September 19, 2017 (Actual)

Primary Completion Date

December 20, 2018 (Actual)

Study Completion Date

February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

Collaborators

Palo Alto Veterans Institute for Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PTSD Coach Condition

Arm Type

Experimental

Arm Description

PTSD Coach App

Arm Title

Treatment as Usual Condition

Arm Type

No Intervention

Arm Description

Treatment as Usual

Intervention Type

Other

Intervention Name(s)

PTSD Coach mobile application

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

PTSD symptoms

Time Frame

past 30-days

Secondary Outcome Measure Information:

Title

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

Description

8-items assessing pain interference

Time Frame

7-days

Title

Short Form of the PROMIS Pain Intensity Scale

Description

3-items assessing pain intensity

Time Frame

7-days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria L Pacella, PhD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

Facility Information:

Facility Name

UPMC Presbyterian Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

UPMC Mercy Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15219

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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.

Citations:

PubMed Identifier

34398631

Citation

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.

Results Reference

derived

PubMed Identifier

32339359

Citation

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.

Results Reference

derived

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The Mobile PTSD Coach App in Acute Injury Survivors

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