A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot

Study Overview
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Brief Summary
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The goal of this pilot study is to develop and implement a larger scale, multi-site stepped collaborative care trial that targets injured patients with presentations of posttraumatic stress disorder (PTSD) and related comorbidities.

Official Title
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A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot

Conditions
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Posttraumatic Stress Disorder, Depression, Alcohol-Related Disorders, Suicidal Ideation, Substance-Related Disorders, Mild Cognitive Impairment, Quality of Life

Intervention / Treatment
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* Behavioral: Motivational Interviewing
* Behavioral: Cognitive Behavioral Therapy Elements
* Drug: Psychotropic Drugs
* Other: Care Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatient/Emergency Admission for traumatic injury Exclusion Criteria: Non-English speaking Self-inflicted injury Actively psychotic Incarcerated or in custody

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements. | Behavioral: Motivational Interviewing<br> <br> Behavioral: Cognitive Behavioral Therapy Elements<br> <br> Drug: Psychotropic Drugs<br> <br> Other: Care Management<br> <br> |
| No Intervention: Usual Care<br>Only standard care practices will be administered to this arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month | The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD. | Baseline and 1-month | 
| Change From Baseline Alcohol Use Disorders Identification at 1 Month | The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome. | Baseline and 1-month | 
| Change From Patient Health Questionnaire 9 Item Depression Scale at 1 Month | The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome. | Baseline and 1-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Status | The investigators will use the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome. | Baseline and 1-month | 
| Patient Health Questionnaire Item 9 Suicide Question | Item 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome. | Baseline and 1-month | 
| Number of Participants Endorsing a Single Item That Assesses Drug Use | Single items that assess drug use across multiple substances (e.g., Cocaine, Prescription Opiates). Single item self-report dichotomized as none versus at least monthly use. | Baseline and 1-month | 
| Cognitive Impairment Scale | The investigators will use the National Study on the Costs and Outcomes of Trauma (NSCOT) Cognitive Screen, a 4 - Item Traumatic Brain Injury / Post-concussive Symptom Screen. The scoring of the scale ranges from a minimum of 4 to a maximum of 20, with lower scores indicating a worse outcome. | Baseline and 1-month |