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

Primary Purpose

Posttraumatic Stress Disorder, Depression, Alcohol-Related Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Psychotropic Drugs
Care Management
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inpatient/Emergency Admission for traumatic injury

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Usual Care

    Arm Description

    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.

    Only standard care practices will be administered to this arm.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    November 14, 2014
    Last Updated
    September 9, 2020
    Sponsor
    University of Washington
    Collaborators
    National Institutes of Health (NIH), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02335125
    Brief Title
    A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot
    Acronym
    TSOS6
    Official Title
    A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington
    Collaborators
    National Institutes of Health (NIH), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posttraumatic Stress Disorder, Depression, Alcohol-Related Disorders, Suicidal Ideation, Substance-Related Disorders, Mild Cognitive Impairment, Quality of Life

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    Only standard care practices will be administered to this arm.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivational Interviewing
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavioral Therapy Elements
    Intervention Type
    Drug
    Intervention Name(s)
    Psychotropic Drugs
    Intervention Type
    Other
    Intervention Name(s)
    Care Management
    Primary Outcome Measure Information:
    Title
    Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month
    Description
    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.
    Time Frame
    Baseline and 1-month
    Title
    Change From Baseline Alcohol Use Disorders Identification at 1 Month
    Description
    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.
    Time Frame
    Baseline and 1-month
    Title
    Change From Patient Health Questionnaire 9 Item Depression Scale at 1 Month
    Description
    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.
    Time Frame
    Baseline and 1-month
    Secondary Outcome Measure Information:
    Title
    Change in Functional Status
    Description
    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.
    Time Frame
    Baseline and 1-month
    Title
    Patient Health Questionnaire Item 9 Suicide Question
    Description
    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.
    Time Frame
    Baseline and 1-month
    Title
    Number of Participants Endorsing a Single Item That Assesses Drug Use
    Description
    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.
    Time Frame
    Baseline and 1-month
    Title
    Cognitive Impairment Scale
    Description
    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.
    Time Frame
    Baseline and 1-month
    Other Pre-specified Outcome Measures:
    Title
    Chronic Medical Condition ICD-9 Definition
    Description
    Moderating Variable
    Time Frame
    Baseline
    Title
    Traumatic Brain Injury Status ICD-9 Definition
    Description
    Moderating Variable
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Inpatient/Emergency Admission for traumatic injury Exclusion Criteria: Non-English speaking Self-inflicted injury Actively psychotic Incarcerated or in custody
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Douglas Zatzick, MD
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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