Completed

NCT Number: NCT02335125

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

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.

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Key information

Conditions

Posttraumatic Stress Disorder Alcohol-Related Disorders Behavior Behavioral Symptoms Chemically-Induced Disorders Cognition Disorders Cognitive Dysfunction Depression Mental Disorders Mild Cognitive Impairment Neurocognitive Disorders Quality of Life Self-Injurious Behavior Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance-Related Disorders Suicidal Ideation Suicide Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inpatient/Emergency Admission for traumatic injury

Exclusion criteria

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

Treatment and study plan

Motivational Interviewing

Behavioral

Cognitive Behavioral Therapy Elements

Behavioral

Psychotropic Drugs

Drug

Care Management

Other

Primary outcomes

Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month

Time frame: Baseline and 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.
Change From Baseline Alcohol Use Disorders Identification at 1 Month

Time frame: Baseline and 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.
Change From Patient Health Questionnaire 9 Item Depression Scale at 1 Month

Time frame: Baseline and 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.

Secondary outcomes

Change in Functional Status

Time frame: Baseline and 1-month

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.
Patient Health Questionnaire Item 9 Suicide Question

Time frame: Baseline and 1-month

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.
Number of Participants Endorsing a Single Item That Assesses Drug Use

Time frame: Baseline and 1-month

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.
Cognitive Impairment Scale

Time frame: Baseline and 1-month

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.

Other outcomes

Chronic Medical Condition ICD-9 Definition

Time frame: Baseline

Moderating Variable
Traumatic Brain Injury Status ICD-9 Definition

Time frame: Baseline

Moderating Variable

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institutes of Health (NIH)

Registry information

Acronym: TSOS6

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jan 9, 2015
Registry last updated: Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed