Trial Outcomes & Findings for A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity (NCT NCT02655354)

NCT ID: NCT02655354

Last Updated: 2021-07-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 635 participants
• Primary outcome timeframe: Baseline, 3-month, 6-month, 12-month
• Results posted on: 2021-07-02

Participant Flow

Participant milestones

Measure	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. 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	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.
Overall Study STARTED	265	370
Overall Study COMPLETED	188	289
Overall Study NOT COMPLETED	77	81

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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 n=635 Participants Total of all reporting groups
Age, Continuous	37.6 years STANDARD_DEVIATION 13.4 • n=5 Participants	39.9 years STANDARD_DEVIATION 14.8 • n=7 Participants	39.0 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	147 Participants n=5 Participants	161 Participants n=7 Participants	308 Participants n=5 Participants
Sex: Female, Male Male	118 Participants n=5 Participants	209 Participants n=7 Participants	327 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	50 Participants n=5 Participants	52 Participants n=7 Participants	102 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	214 Participants n=5 Participants	316 Participants n=7 Participants	530 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	127 Participants n=5 Participants	188 Participants n=7 Participants	315 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	89 Participants n=5 Participants	129 Participants n=7 Participants	218 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Mixed	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	27 Participants n=5 Participants	32 Participants n=7 Participants	59 Participants n=5 Participants
Baseline PCL-C total score	54.0 units on a scale STANDARD_DEVIATION 12.6 • n=5 Participants	50.7 units on a scale STANDARD_DEVIATION 11.2 • n=7 Participants	52.1 units on a scale STANDARD_DEVIATION 11.9 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury Change from Baseline at 3 Months	-1.65 score on a scale Standard Error 0.86	0.08 score on a scale Standard Error 0.74
Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury Change from Baseline at 6 Months	-4.02 score on a scale Standard Error 0.99	-1.44 score on a scale Standard Error 0.83
Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury Change from Baseline at 12 Months	-5.51 score on a scale Standard Error 1.18	-4.25 score on a scale Standard Error 0.97

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury Change from Baseline at 6 Months	-1.17 score on a scale Standard Error 0.45	-0.90 score on a scale Standard Error 0.38
Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury Change from Baseline at 12 Months	-1.84 score on a scale Standard Error 0.52	-2.16 score on a scale Standard Error 0.43
Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury Change from Baseline at 3 Months	-0.79 score on a scale Standard Error 0.40	-0.50 score on a scale Standard Error 0.35

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury Change from Baseline at 3 Months	-2.04 score on a scale Standard Error 0.21	-1.90 score on a scale Standard Error 0.18
Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury Change from Baseline at 6 Months	-1.69 score on a scale Standard Error 0.22	-1.63 score on a scale Standard Error 0.19
Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury Change from Baseline at 12 Months	-1.81 score on a scale Standard Error 0.23	-1.45 score on a scale Standard Error 0.19

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury Change from Baseline at 3 Months	-16.78 score on a scale Standard Error 0.69	-15.90 score on a scale Standard Error 0.59
Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury Change from Baseline at 6 Months	-14.17 score on a scale Standard Error 0.79	-13.83 score on a scale Standard Error 0.66
Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury Change from Baseline at 12 Months	-13.23 score on a scale Standard Error 0.94	-11.68 score on a scale Standard Error 0.77

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
Number of Participants With Suicidal Ideation Baseline	67 Participants	90 Participants
Number of Participants With Suicidal Ideation 3 Month	69 Participants	99 Participants
Number of Participants With Suicidal Ideation 6 Month	63 Participants	106 Participants
Number of Participants With Suicidal Ideation 12 Month	51 Participants	92 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
Number of Participants Endorsing a Single Item That Assesses Opioid Use Baseline	18 Participants	44 Participants
Number of Participants Endorsing a Single Item That Assesses Opioid Use 3 Month	4 Participants	15 Participants
Number of Participants Endorsing a Single Item That Assesses Opioid Use 6 Month	4 Participants	20 Participants
Number of Participants Endorsing a Single Item That Assesses Opioid Use 12 Month	6 Participants	6 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
Cognitive Impairment Scale Baseline	13.5 score on a scale Standard Deviation 4.6	13.4 score on a scale Standard Deviation 4.5
Cognitive Impairment Scale 3 Month	13.3 score on a scale Standard Deviation 4.5	13.2 score on a scale Standard Deviation 4.5
Cognitive Impairment Scale 6 Month	13.2 score on a scale Standard Deviation 4.7	13.4 score on a scale Standard Deviation 4.1
Cognitive Impairment Scale 12 Month	13.8 score on a scale Standard Deviation 4.7	14.2 score on a scale Standard Deviation 4.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
Brief Pain Inventory Baseline	6.8 score on a scale Standard Deviation 2.4	6.7 score on a scale Standard Deviation 2.7
Brief Pain Inventory 3 Month	4.3 score on a scale Standard Deviation 2.9	4.7 score on a scale Standard Deviation 2.8
Brief Pain Inventory 6 Month	4.1 score on a scale Standard Deviation 3.1	4.5 score on a scale Standard Deviation 3.0
Brief Pain Inventory 12 Month	3.9 score on a scale Standard Deviation 3.0	3.8 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
SF-36 Quality of Life 12 Month	39.2 score on a scale Standard Deviation 13.6	41.4 score on a scale Standard Deviation 11.9
SF-36 Quality of Life Baseline	44.3 score on a scale Standard Deviation 13.9	45.1 score on a scale Standard Deviation 13.0
SF-36 Quality of Life 3 Month	38.3 score on a scale Standard Deviation 12.4	39.1 score on a scale Standard Deviation 13.0
SF-36 Quality of Life 6 Month	38.4 score on a scale Standard Deviation 14.0	39.5 score on a scale Standard Deviation 12.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
TSOS Patient Satisfaction: Overall Health Care Baseline	4.4 score on a scale Standard Deviation 0.9	4.4 score on a scale Standard Deviation 0.9
TSOS Patient Satisfaction: Overall Health Care 3 Month	3.9 score on a scale Standard Deviation 1.1	3.8 score on a scale Standard Deviation 1.1
TSOS Patient Satisfaction: Overall Health Care 6 Month	4.0 score on a scale Standard Deviation 1.1	3.8 score on a scale Standard Deviation 1.1
TSOS Patient Satisfaction: Overall Health Care 12 Month	3.9 score on a scale Standard Deviation 1.1	3.8 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
Number of Participants Endorsing a Single Item That Assesses Stimulant Use 3 Month	9 Participants	17 Participants
Number of Participants Endorsing a Single Item That Assesses Stimulant Use Baseline	58 Participants	77 Participants
Number of Participants Endorsing a Single Item That Assesses Stimulant Use 6 Month	7 Participants	22 Participants
Number of Participants Endorsing a Single Item That Assesses Stimulant Use 12 Month	8 Participants	16 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
Number of Participants Endorsing a Single Item That Assesses Marijuana Use Baseline	125 Participants	177 Participants
Number of Participants Endorsing a Single Item That Assesses Marijuana Use 3 Month	60 Participants	72 Participants
Number of Participants Endorsing a Single Item That Assesses Marijuana Use 6 Month	60 Participants	82 Participants
Number of Participants Endorsing a Single Item That Assesses Marijuana Use 12 Month	51 Participants	79 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Intervention n=265 Participants 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	Usual Care n=370 Participants 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.
TSOS Patient Satisfaction: Mental Health Care Baseline	4.1 score on a scale Standard Deviation 1.0	4.0 score on a scale Standard Deviation 1.1
TSOS Patient Satisfaction: Mental Health Care 3 Month	3.6 score on a scale Standard Deviation 1.1	3.5 score on a scale Standard Deviation 1.1
TSOS Patient Satisfaction: Mental Health Care 6 Month	3.6 score on a scale Standard Deviation 1.1	3.4 score on a scale Standard Deviation 4.1
TSOS Patient Satisfaction: Mental Health Care 12 Month	3.7 score on a scale Standard Deviation 1.1	3.5 score on a scale Standard Deviation 1.1

Adverse Events

Intervention

Serious events: 15 serious events

Other events: 134 other events

Deaths: 6 deaths

Usual Care

Serious events: 13 serious events

Other events: 197 other events

Deaths: 3 deaths

Serious adverse events

Measure	Intervention n=265 participants at risk 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	Usual Care n=370 participants at risk 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.
Injury, poisoning and procedural complications Suicide Attempt	3.4% 9/265 • Baseline, 3 Month, 6 Month, and 12 Month	2.7% 10/370 • Baseline, 3 Month, 6 Month, and 12 Month
General disorders Death	2.3% 6/265 • Baseline, 3 Month, 6 Month, and 12 Month	0.81% 3/370 • Baseline, 3 Month, 6 Month, and 12 Month

Other adverse events

Measure	Intervention n=265 participants at risk 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	Usual Care n=370 participants at risk 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.
Psychiatric disorders Suicidal Ideation	50.6% 134/265 • Baseline, 3 Month, 6 Month, and 12 Month	53.2% 197/370 • Baseline, 3 Month, 6 Month, and 12 Month

Additional Information

Douglas Zatzick

University of Washington School of Medicine

Phone: 206-744-6701

Email: dzatzick@uw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place