A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot (TSOS6)

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Depression; Alcohol-Related Disorders; Quality of Life; Suicidal Ideation; Mild Cognitive Impairment; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Motivational Interviewing; Behavioral: Cognitive Behavioral Therapy Elements; Drug: Psychotropic Drugs; Other: Care Management

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inpatient/Emergency Admission for traumatic injury

Exclusion Criteria:

• Non-English speaking
• Self-inflicted injury
• Actively psychotic
• Incarcerated or in custody

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Behavioral: Cognitive Behavioral Therapy Elements; Drug: Psychotropic Drugs; Other: Care Management
No Intervention: Usual Care; Only standard care practices will be administered to this arm.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic Medical Condition ICD-9 Definition	Moderating Variable	Baseline
Traumatic Brain Injury Status ICD-9 Definition	Moderating Variable	Baseline

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Institute of Mental Health (NIMH); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 9, 2015

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Neurocognitive Disorders; Trauma and Stressor Related Disorders; Cognition Disorders; Self-Injurious Behavior; Stress Disorders, Traumatic; Suicide; Substance-Related Disorders; Disease; Stress Disorders, Post-Traumatic; Cognitive Dysfunction; Suicidal Ideation; Alcohol-Related Disorders; Psychotropic Drugs
• Other Study ID Numbers: STUDY00010782; UH2MH106338 (U.S. NIH Grant/Contract)