Chronic PainNCT03247179
The Mobile PTSD Coach App in Acute Injury Survivors
A study testing PTSD Coach mobile application in people with Chronic Pain and Acute Pain Due to Trauma, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Acute Pain Due to Trauma, Posttraumatic Stress Disorder
- What is being tested?
- PTSD Coach mobile application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2017to 15 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, 15219
About this study
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
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.
Read the 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.
- Being tested
- PTSD Coach mobile application
- Medical subject headings
- Chronic Pain, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTSD Coach mobile applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PTSD Coach Condition | Experimental | PTSD Coach App Receives: Other: PTSD Coach mobile application |
| Treatment as Usual Condition | No intervention | Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM 5 (Diagnostic and Statistical Manual for Mental Disorders-5)
PTSD symptoms
Measured: past 30-days
Secondary outcomes (2)
Short Form of the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale
8-items assessing pain interference
Measured: 7-days
Short Form of the PROMIS Pain Intensity Scale
3-items assessing pain intensity
Measured: 7-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start19 Sep 2017
- Primary completion20 Dec 2018
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Palo Alto Veterans Institute for Research
- Responsible party
- Principal investigator, Maria Pacella, University of Pittsburgh
- Investigators
- Maria L Pacella, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247179
- Sponsor's protocol ID
- PRO16010595
- Status last verified
- Mar 2019
- First submitted
- 8 Aug 2017
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Plaitano EG, Hamed HH, Kuhn E, Suffoletto BP, Pacella-LaBarbara ML. Cognitive appraisal processes mediate postinjury pain and disability: A longitudinal observational study. Rehabil Psychol. 2026 Oct 5. doi: 10.1037/rep0000696. Online ahead of print.
PubMed 42831843Pacella-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.
PubMed 36821344Brienza 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.
PubMed 34398631Pacella-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.
PubMed 32339359
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03247179
- Acronym / sponsor ID
- PRO16010595
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Palo Alto Veterans Institute for Research
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the experimental condition (PTSD Coach app usage), or the treatment as usual condition.
| Arm | Type | Receives |
|---|---|---|
| PTSD Coach Condition | Experimental | Other: PTSD Coach mobile applicationPTSD Coach App |
| Treatment as Usual Condition | No intervention | –Treatment as Usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTSD Coach mobile applicationThe 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. | Other | PTSD Coach Condition |
Primary outcome
PTSD Checklist for DSM 5 (Diagnostic and Statistical Manual for Mental Disorders-5)
Time frame: past 30-days
PTSD symptoms
2 secondary outcomes
Short Form of the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale
Time frame: 7-days
Short Form of the PROMIS Pain Intensity Scale
Time frame: 7-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Derived from this study: PubMed 42831843Plaitano EG, Hamed HH, Kuhn E, Suffoletto BP, Pacella-LaBarbara ML. Cognitive appraisal processes mediate postinjury pain and disability: A longitudinal observational study. Rehabil Psychol. 2026 Oct 5. doi: 10.1037/rep0000696. Online ahead of print.
- Derived from this study: PubMed 36821344Pacella-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.
- Derived from this study: PubMed 34398631Brienza 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.
- Derived from this study: PubMed 32339359Pacella-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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria L Pacella, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTSD Coach mobile application in people with Chronic Pain and Acute Pain Due to Trauma, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM 5 (Diagnostic and Statistical Manual for Mental Disorders-5) (time frame: past 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03247179, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.