TSOS6: A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT02655354
Collaborator
National Institutes of Health (NIH) (NIH), National Institute of Mental Health (NIMH) (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
635
24
2
49
26.5
0.5

Study Details

Study Description

Brief Summary

The overarching goal of this UH2-UH3 proposal is to work with the NIH Health Care Systems Research Collaboratory to develop and implement a large scale, cluster randomized pragmatic clinical trial demonstration project that directly informs national trauma care system policy targeting injured patients with presentations of Posttraumatic Stress Disorder (PTSD) and related comorbidity. Each year in the United States (US), over 30 million individuals present to trauma centers, emergency departments, and other acute care medical settings for the treatment of physical injuries. Multiple chronic conditions including enduring PTSD, alcohol and drug use problems, depression and associated suicidal ideation, pain and somatic symptom amplification, and chronic medical conditions (e.g., hypertension, coronary artery disease, diabetes, and pulmonary diseases) are endemic among physical trauma survivors with and without traumatic brain injuries (TBI). Evidence-based, collaborative care/care management treatment models for PTSD and related comorbidities exist. These care management models have the potential to be flexibly implemented in order 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; care management models may also be effective in mitigating the impact of the acute injury event on symptom exacerbations in the large subpopulation of injury survivors who already carry a substantial pre-injury burden of multiple chronic medical conditions.

Detailed Description

Primary Aims and Hypotheses

The primary aim of the UH3 period is to conduct a pragmatic randomized effectiveness trial of a collaborative care intervention targeting PTSD and comorbid conditions after acute care injury hospitalization. The investigation aims to determine if injured patients receiving the collaborative care intervention demonstrate significant reductions in PTSD symptoms when compared to control patients receiving care as usual. The study also aims to determine if the intervention patients when compared to control patients will demonstrate significant reductions in depressive symptoms, suicidal ideation, and alcohol use problems, and improvements in physical function. The primary hypothesis is that the intervention group when compared to the control group will demonstrate significant reductions in PTSD symptoms over the course of the year after injury. Secondary hypotheses are that intervention patients when compared to control patients will demonstrate, significant reductions in depressive symptoms, significant reductions in alcohol use problems, and improved post-injury physical function.

A Priori Secondary Analyses

The study team hypothesizes that a subgroup of patients will have persistent PTSD symptoms that will not remit over the longitudinal course of the investigation, regardless of randomization to intervention or control group conditions. The study team also anticipates that readily identifiable baseline clinical, injury and demographic characteristics will be associated with persistent PTSD symptoms over time (e.g., higher PTSD symptom levels, greater pre-injury trauma exposure, intentional injury including firearm related injury mechanisms and other characteristics such as unemployment, as well as other baseline factors). Derived from previous randomized clinical trials, a cumulative burden index has been developed from these baseline characteristics and will be adapted for the current investigation. The study team proposes a series of secondary analyses that adjust for and stratify by baseline characteristics that put patients at risk for persistent symptoms. It is hypothesized that these secondary analyses will identify a subgroup of intervention patients who are not at risk for persistent symptoms and who will demonstrate clinically and statistically significant treatment responses when compared to patients with similar baseline characteristics in the control condition. The study team also hypothesizes that the treatment effects will be greatest at the 1-6 month post-injury time points that are temporally correlated with the period of active intervention.

Study Design

Study Type:
Interventional
Actual Enrollment :
635 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Study Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Nov 1, 2019
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements.

Behavioral: Motivational Interviewing

Behavioral: Cognitive Behavioral Therapy Elements

Behavioral: Care Management

Drug: Fluoxetine
Anti-depressant

Drug: Fluvoxamine
Anti-depressant

Drug: Paroxetine
Anti-depressant

Drug: Sertraline
Anti-depressant

Drug: Citalopram
Anti-depressant

Drug: Venlafaxine
Anti-depressant

Drug: Duloxetine
Anti-depressant

Drug: Mirtazapine
Anti-depressant

Drug: Diphenhydramine
Sleep medication

Drug: Trazodone
Sleep medication

Drug: Prazosin
Sleep medication

No Intervention: Usual Care

Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury [Baseline, 3-month, 6-month, 12-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.

  2. Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury [Baseline, 3-month, 6-month, 12-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.

  3. Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury [Baseline, 3-month, 6-month, 12-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.

  4. Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury [Baseline, 3-month, 6-month, 12-month]

    The investigators used 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.

Secondary Outcome Measures

  1. Number of Participants With Suicidal Ideation [Baseline, 3-month, 6-month, 12-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.

  2. Number of Participants Endorsing a Single Item That Assesses Opioid Use [Baseline, 3-month, 6-month, 12-month]

    Single items that assess non-prescribed opioid use. Single item self-report dichotomized as none versus at least monthly use.

  3. Cognitive Impairment Scale [Baseline, 3-month, 6-month, 12-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.

  4. Brief Pain Inventory [Baseline, 3-month, 6-month, 12-month]

    A brief measure scored on a 0 to 10 scale to assess a patient's pain, with a higher score indicating more severe pain; a score of 0 indicates no pain and a score of 10 indicates very severe pain.

  5. SF-36 Quality of Life [Baseline, 3-month, 6-month, 12-month]

    The SF-36 assess quality of life domains that span emotional health, overall health status, and role function; a score of 100 indicates perfect health and a score of 0 indicates extremely poor health.

  6. TSOS Patient Satisfaction: Overall Health Care [Baseline, 3-month, 6-month, 12-month]

    Satisfaction with health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.

  7. Number of Participants Endorsing a Single Item That Assesses Stimulant Use [Baseline, 3-month, 6-month, 12-month]

    Single items that assess non-prescribed stimulant use. Single item self-report dichotomized as none versus at least monthly use.

  8. Number of Participants Endorsing a Single Item That Assesses Marijuana Use [Baseline, 3-month, 6-month, 12-month]

    Single items that assess marijuana use. Single item self-report dichotomized as none versus at least monthly use.

  9. TSOS Patient Satisfaction: Mental Health Care [Baseline, 3 Month, 6 Month, 12 Month]

    Satisfaction with mental health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient currently admitted to inpatient/emergency department for a traumatic injury
Exclusion Criteria:
  • Non-English speaking

  • Self-inflicted injury

  • Actively psychotic

  • Incarcerated or in custody

  • Less than 35 on PTSD Checklist

  • Less than 3 items on PTSD medical record screen

  • Less than 2 pieces of contact information

Contacts and Locations

Locations

Site City State Country Postal Code
1 Honor Health Scottsdale Arizona United States 85251
2 Cedars Sinai Beverly Hills California United States 90211
3 U.C. Davis Sacramento California United States 95816
4 Santa Clara Valley Medical Center San Jose California United States 95128
5 U.C.L.A. Harbor Torrance California United States 90509
6 Hartford Hospital Hartford Connecticut United States 06102
7 Georgia Regents Augusta Georgia United States 30912
8 Eskenazi Health Indianapolis Indiana United States 46202
9 University of Iowa Iowa City Iowa United States 52242
10 University of Kentucky Lexington Kentucky United States 40536
11 Louisiana State University New Orleans Louisiana United States 70112
12 Regions Hospital Saint Paul Minnesota United States 55101
13 Jacobi Medical Center Bronx New York United States 10461
14 University of Rochester Rochester New York United States 14642
15 Wake Forest Winston-Salem North Carolina United States 27157
16 University of Cincinnati Cincinnati Ohio United States 45267
17 Ohio State University Columbus Ohio United States 43210
18 Baylor Health Care System Dallas Texas United States 75204
19 UT Southwestern Medical Center Dallas Texas United States 75390
20 University of Texas Medical Branch at Galveston Galveston Texas United States 77555
21 The University of Utah Salt Lake City Utah United States 84132
22 The University of Vermont Burlington Vermont United States 05405
23 Inova Trauma Center Falls Church Virginia United States 22042
24 The University of Wisconsin Madison Madison Wisconsin United States 53715

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Douglas Zatzick, MD, University of Washington

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Douglas Zatzick, Professor, University of Washington
ClinicalTrials.gov Identifier:
NCT02655354
Other Study ID Numbers:
  • 20150987
  • UH3MH106338
First Posted:
Jan 14, 2016
Last Update Posted:
Jul 2, 2021
Last Verified:
Jul 1, 2021

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Period Title: Overall Study
STARTED 265 370
COMPLETED 188 289
NOT COMPLETED 77 81

Baseline Characteristics

Arm/Group Title Intervention Usual Care Total
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject. Total of all reporting groups
Overall Participants 265 370 635
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
37.6
(13.4)
39.9
(14.8)
39.0
(14.2)
Sex: Female, Male (Count of Participants)
Female
147
55.5%
161
43.5%
308
48.5%
Male
118
44.5%
209
56.5%
327
51.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
50
18.9%
52
14.1%
102
16.1%
Not Hispanic or Latino
214
80.8%
316
85.4%
530
83.5%
Unknown or Not Reported
1
0.4%
2
0.5%
3
0.5%
Race/Ethnicity, Customized (Count of Participants)
White
127
47.9%
188
50.8%
315
49.6%
Black
89
33.6%
129
34.9%
218
34.3%
American Indian
6
2.3%
9
2.4%
15
2.4%
Asian
2
0.8%
2
0.5%
4
0.6%
Pacific Islander
3
1.1%
1
0.3%
4
0.6%
Mixed
11
4.2%
9
2.4%
20
3.1%
Other
27
10.2%
32
8.6%
59
9.3%
Baseline PCL-C total score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
54.0
(12.6)
50.7
(11.2)
52.1
(11.9)

Outcome Measures

1. Primary Outcome
Title Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury
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, 3-month, 6-month, 12-month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Change from Baseline at 3 Months
-1.65
(0.86)
0.08
(0.74)
Change from Baseline at 6 Months
-4.02
(0.99)
-1.44
(0.83)
Change from Baseline at 12 Months
-5.51
(1.18)
-4.25
(0.97)
2. Primary Outcome
Title Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury
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, 3-month, 6-month, 12-month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Change from Baseline at 3 Months
-0.79
(0.40)
-0.50
(0.35)
Change from Baseline at 6 Months
-1.17
(0.45)
-0.90
(0.38)
Change from Baseline at 12 Months
-1.84
(0.52)
-2.16
(0.43)
3. Primary Outcome
Title Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury
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, 3-month, 6-month, 12-month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Change from Baseline at 3 Months
-2.04
(0.21)
-1.90
(0.18)
Change from Baseline at 6 Months
-1.69
(0.22)
-1.63
(0.19)
Change from Baseline at 12 Months
-1.81
(0.23)
-1.45
(0.19)
4. Primary Outcome
Title Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury
Description The investigators used 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, 3-month, 6-month, 12-month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Change from Baseline at 3 Months
-16.78
(0.69)
-15.90
(0.59)
Change from Baseline at 6 Months
-14.17
(0.79)
-13.83
(0.66)
Change from Baseline at 12 Months
-13.23
(0.94)
-11.68
(0.77)
5. Secondary Outcome
Title Number of Participants With Suicidal Ideation
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, 3-month, 6-month, 12-month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Baseline
67
25.3%
90
24.3%
3 Month
69
26%
99
26.8%
6 Month
63
23.8%
106
28.6%
12 Month
51
19.2%
92
24.9%
6. Secondary Outcome
Title Number of Participants Endorsing a Single Item That Assesses Opioid Use
Description Single items that assess non-prescribed opioid use. Single item self-report dichotomized as none versus at least monthly use.
Time Frame Baseline, 3-month, 6-month, 12-month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Baseline
18
6.8%
44
11.9%
3 Month
4
1.5%
15
4.1%
6 Month
4
1.5%
20
5.4%
12 Month
6
2.3%
6
1.6%
7. Secondary Outcome
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, 3-month, 6-month, 12-month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Baseline
13.5
(4.6)
13.4
(4.5)
3 Month
13.3
(4.5)
13.2
(4.5)
6 Month
13.2
(4.7)
13.4
(4.1)
12 Month
13.8
(4.7)
14.2
(4.1)
8. Secondary Outcome
Title Brief Pain Inventory
Description A brief measure scored on a 0 to 10 scale to assess a patient's pain, with a higher score indicating more severe pain; a score of 0 indicates no pain and a score of 10 indicates very severe pain.
Time Frame Baseline, 3-month, 6-month, 12-month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Baseline
6.8
(2.4)
6.7
(2.7)
3 Month
4.3
(2.9)
4.7
(2.8)
6 Month
4.1
(3.1)
4.5
(3.0)
12 Month
3.9
(3.0)
3.8
(3.0)
9. Secondary Outcome
Title SF-36 Quality of Life
Description The SF-36 assess quality of life domains that span emotional health, overall health status, and role function; a score of 100 indicates perfect health and a score of 0 indicates extremely poor health.
Time Frame Baseline, 3-month, 6-month, 12-month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Baseline
44.3
(13.9)
45.1
(13.0)
3 Month
38.3
(12.4)
39.1
(13.0)
6 Month
38.4
(14.0)
39.5
(12.2)
12 Month
39.2
(13.6)
41.4
(11.9)
10. Secondary Outcome
Title TSOS Patient Satisfaction: Overall Health Care
Description Satisfaction with health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Time Frame Baseline, 3-month, 6-month, 12-month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Baseline
4.4
(0.9)
4.4
(0.9)
3 Month
3.9
(1.1)
3.8
(1.1)
6 Month
4.0
(1.1)
3.8
(1.1)
12 Month
3.9
(1.1)
3.8
(1.2)
11. Secondary Outcome
Title Number of Participants Endorsing a Single Item That Assesses Stimulant Use
Description Single items that assess non-prescribed stimulant use. Single item self-report dichotomized as none versus at least monthly use.
Time Frame Baseline, 3-month, 6-month, 12-month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Baseline
58
21.9%
77
20.8%
3 Month
9
3.4%
17
4.6%
6 Month
7
2.6%
22
5.9%
12 Month
8
3%
16
4.3%
12. Secondary Outcome
Title Number of Participants Endorsing a Single Item That Assesses Marijuana Use
Description Single items that assess marijuana use. Single item self-report dichotomized as none versus at least monthly use.
Time Frame Baseline, 3-month, 6-month, 12-month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Baseline
125
47.2%
177
47.8%
3 Month
60
22.6%
72
19.5%
6 Month
60
22.6%
82
22.2%
12 Month
51
19.2%
79
21.4%
13. Secondary Outcome
Title TSOS Patient Satisfaction: Mental Health Care
Description Satisfaction with mental health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Time Frame Baseline, 3 Month, 6 Month, 12 Month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
Measure Participants 265 370
Baseline
4.1
(1.0)
4.0
(1.1)
3 Month
3.6
(1.1)
3.5
(1.1)
6 Month
3.6
(1.1)
3.4
(4.1)
12 Month
3.7
(1.1)
3.5
(1.1)

Adverse Events

Time Frame Baseline, 3 Month, 6 Month, and 12 Month
Adverse Event Reporting Description
Arm/Group Title Intervention Usual Care
Arm/Group 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 traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Care Management Fluoxetine: Anti-depressant Fluvoxamine: Anti-depressant Paroxetine: Anti-depressant Sertraline: Anti-depressant Citalopram: Anti-depressant Venlafaxine: Anti-depressant Duloxetine: Anti-depressant Mirtazapine: Anti-depressant Diphenhydramine: Sleep medication Trazodone: Sleep medication Prazosin: Sleep medication Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject.
All Cause Mortality
Intervention Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 6/265 (2.3%) 3/370 (0.8%)
Serious Adverse Events
Intervention Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 15/265 (5.7%) 13/370 (3.5%)
General disorders
Death 6/265 (2.3%) 3/370 (0.8%)
Injury, poisoning and procedural complications
Suicide Attempt 9/265 (3.4%) 10/370 (2.7%)
Other (Not Including Serious) Adverse Events
Intervention Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 134/265 (50.6%) 197/370 (53.2%)
Psychiatric disorders
Suicidal Ideation 134/265 (50.6%) 197/370 (53.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Douglas Zatzick
Organization University of Washington School of Medicine
Phone 206-744-6701
Email dzatzick@uw.edu
Responsible Party:
Douglas Zatzick, Professor, University of Washington
ClinicalTrials.gov Identifier:
NCT02655354
Other Study ID Numbers:
  • 20150987
  • UH3MH106338
First Posted:
Jan 14, 2016
Last Update Posted:
Jul 2, 2021
Last Verified:
Jul 1, 2021