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Clinical Trials/NCT02335125
NCT02335125
Completed
Not Applicable

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

University of Washington0 sites40 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Motivational Interviewing
Conditions
Posttraumatic Stress Disorder
Sponsor
University of Washington
Enrollment
40
Primary Endpoint
Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
August 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Douglas Zatzick

Professor, Psychiatry & Behavioral Sciences

University of Washington

Eligibility Criteria

Inclusion Criteria

  • Inpatient/Emergency Admission for traumatic injury

Exclusion Criteria

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

Arms & Interventions

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.

Intervention: Motivational Interviewing

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.

Intervention: Cognitive Behavioral Therapy Elements

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.

Intervention: Psychotropic Drugs

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.

Intervention: Care Management

Outcomes

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 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.

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.

Secondary Outcomes

  • Change in Functional Status(Baseline and 1-month)
  • Patient Health Questionnaire Item 9 Suicide Question(Baseline and 1-month)
  • Number of Participants Endorsing a Single Item That Assesses Drug Use(Baseline and 1-month)
  • Cognitive Impairment Scale(Baseline and 1-month)

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