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
About this trial
This is an interventional health services research trial for Posttraumatic Stress Disorder
Eligibility Criteria
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
NCT ID
NCT02335125
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)
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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