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

NCT02335125 | Completed Results DMC

• 2 other identifiers: STUDY00010782UH2MH106338
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Other Outcomes (2)

• Chronic Medical Condition ICD-9 Definition

  Baseline

• Traumatic Brain Injury Status ICD-9 Definition

  Baseline

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Only standard care practices will be administered to this arm.

Interventions

Motivational Interviewing BEHAVIORAL

Intervention

Cognitive Behavioral Therapy Elements BEHAVIORAL

Intervention

Psychotropic Drugs DRUG

Intervention

Care Management OTHER

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Inpatient/Emergency Admission for traumatic injury

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Alcohol-Related Disorders; Suicidal Ideation; Substance-Related Disorders; Cognitive Dysfunction

Interventions

Motivational Interviewing; Psychotropic Drugs

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Chemically-Induced Disorders; Suicide; Self-Injurious Behavior; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Limitations and Caveats

During the pilot study roll-out it was noted that rather than characterizing trauma center providers as staff versus care managers, that a better characterization was to split staff across two trauma centers; this update was made on 2/6/19.

Results Point of Contact

• Title: Douglas Zatzick, MD
• Organization: University of Washington Harborview Medical Center

dzatzick@uw.edu

(206) 744-6701

Study Officials

• Douglas Zatzick, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry & Behavioral Sciences

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: January 9, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 11, 2020
• Results First Posted: September 11, 2020

Record last verified: 2020-09