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| Name | Class |
|---|---|
| Palo Alto Veterans Institute for Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTSD Coach Condition | Experimental | PTSD Coach App |
|
| Treatment as Usual Condition | No Intervention | Treatment as Usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist for DSM 5 (Diagnostic and Statistical Manual for Mental Disorders-5) | PTSD symptoms | past 30-days |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form of the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale | 8-items assessing pain interference | 7-days |
| Short Form of the PROMIS Pain Intensity Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria L Pacella, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States | ||
| UPMC Mercy Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36821344 | Derived | 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. | |
| 34398631 | 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. |
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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.
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants will be randomly assigned to either the experimental condition (PTSD Coach app usage), or the treatment as usual condition.
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3-items assessing pain intensity
| 7-days |
| Pittsburgh |
| Pennsylvania |
| 15219 |
| United States |
| 32339359 | 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. |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |