A Policy Relevant US Trauma Care System Pragmatic Trial f... | NCT02655354

NCT02655354

ID	Type	Description	Link
UH3MH106338	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
National Institutes of Health (NIH)	NIH
National Institute of Mental Health (NIMH)	NIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	NIH

Oversight Module

Description Module

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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both 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 Drug: Fluvoxamine Drug: Paroxetine Drug: Sertraline Drug: Citalopram Drug: Venlafaxine Drug: Duloxetine Drug: Mirtazapine Drug: Diphenhydramine Drug: Trazodone Drug: Prazosin
Usual Care	No Intervention	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.

Name	Type	Description	Arm Group Labels	Other Names
Motivational Interviewing	Behavioral		Intervention
Cognitive Behavioral Therapy Elements

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury	The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.	Baseline, 3-month, 6-month, 12-month
Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury	The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome.	Baseline, 3-month, 6-month, 12-month
Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury	The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.	Baseline, 3-month, 6-month, 12-month
Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury	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.	Baseline, 3-month, 6-month, 12-month

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Suicidal Ideation	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.	Baseline, 3-month, 6-month, 12-month

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Douglas Zatzick, MD	University of Washington	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Honor Health		Scottsdale	Arizona	85251	United States
Cedars Sinai

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38287923	Derived	Abu K, Bedard-Gilligan M, Moodliar R, Bulger EM, Hernandez A, Knutzen T, Shoyer J, Birk N, Conde C, Engstrom A, Ryan P, Wang J, Russo J, Zatzick DF. Can stepped collaborative care interventions improve post-traumatic stress disorder symptoms for racial and ethnic minority injury survivors? Trauma Surg Acute Care Open. 2024 Jan 24;9(1):e001232. doi: 10.1136/tsaco-2023-001232. eCollection 2024.
37085877	Derived	Zatzick D, Palinkas L, Chambers DA, Whiteside L, Moloney K, Engstrom A, Prater L, Russo J, Wang J, Abu K, Iles-Shih M, Bulger E. Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis. Trials. 2023 Apr 21;24(1):288. doi: 10.1186/s13063-023-07313-0.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 17, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00037.6± 13.4 BG00139.9± 14.8 BG00239.0± 14.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000147 BG001161 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00050 BG00152 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race

Title	Measurements
White	BG000127 BG001188 BG002

Baseline PCL-C total score

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.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00054.0± 12.6 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury

Posted

Mean

Standard Error

score on a scale

Baseline, 3-month, 6-month, 12-month

ID	Title	Description
OG000	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
OG001	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.

Units	Counts
Participants	OG000265 OG001370

Title

Denominators

Categories

Change from Baseline at 3 Months

Title	Measurements
	OG000-1.65± 0.86 OG0010.08± 0.74

Change from Baseline at 6 Months

Title	Measurements
	OG000

Primary

Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury

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.

Posted

Mean

Standard Error

score on a scale

Baseline, 3-month, 6-month, 12-month

ID	Title	Description
OG000	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
OG001	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.

Primary

Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury

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.

Posted

Mean

Standard Error

score on a scale

Baseline, 3-month, 6-month, 12-month

ID	Title	Description
OG000	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
OG001	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.

Primary

Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury

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.

Posted

Mean

Standard Error

score on a scale

Baseline, 3-month, 6-month, 12-month

ID	Title	Description
OG000	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
OG001	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.

Secondary

Number of Participants With Suicidal Ideation

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.

Posted

Count of Participants

Participants

Baseline, 3-month, 6-month, 12-month

ID	Title	Description
OG000	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
OG001	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.

Secondary

Number of Participants Endorsing a Single Item That Assesses Opioid Use

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

Posted

Count of Participants

Participants

Baseline, 3-month, 6-month, 12-month

ID	Title	Description
OG000	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
OG001	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.

Secondary

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3-month, 6-month, 12-month

ID	Title	Description
OG000	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
OG001	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.

Secondary

Brief Pain Inventory

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3-month, 6-month, 12-month

ID	Title	Description
OG000	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
OG001	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.

Secondary

SF-36 Quality of Life

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3-month, 6-month, 12-month

ID	Title	Description
OG000	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
OG001	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.

Secondary

TSOS Patient Satisfaction: Overall Health Care

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3-month, 6-month, 12-month

ID	Title	Description
OG000	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
OG001	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.

Secondary

Number of Participants Endorsing a Single Item That Assesses Stimulant Use

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

Posted

Count of Participants

Participants

Baseline, 3-month, 6-month, 12-month

ID	Title	Description
OG000	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
OG001	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.

Secondary

Number of Participants Endorsing a Single Item That Assesses Marijuana Use

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

Posted

Count of Participants

Participants

Baseline, 3-month, 6-month, 12-month

ID	Title	Description
OG000	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
OG001	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.

Secondary

TSOS Patient Satisfaction: Mental Health Care

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, 3 Month, 6 Month, 12 Month

ID	Title	Description
OG000	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
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	6	265	15	265	134	265
EG001	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.	3	370	13	370	197	370

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Suicide Attempt	Injury, poisoning and procedural complications		Systematic Assessment		EG0009 affected265 at risk EG00110 affected370 at risk
Death	General disorders		Systematic Assessment		EG0006 affected265 at risk EG0013 affected370 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Suicidal Ideation	Psychiatric disorders		Systematic Assessment		EG000134 affected265 at risk EG001197 affected370 at risk

ID	Term
D013313	Stress Disorders, Post-Traumatic
D003863	Depression
D019973	Alcohol-Related Disorders
D059020	Suicidal Ideation
D019966	Substance-Related Disorders
D060825	Cognitive Dysfunction
D010146	Pain
D014947	Wounds and Injuries
D001930	Brain Injuries
D002908	Chronic Disease

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior
D064419	Chemically-Induced Disorders
D013405	Suicide
D016728	Self-Injurious Behavior
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D020969	Disease Attributes
D010335	Pathologic Processes

ID	Term
D062405	Motivational Interviewing
D005473	Fluoxetine
D016666	Fluvoxamine
D017374	Paroxetine
D020280	Sertraline
D015283	Citalopram
D000069470	Venlafaxine Hydrochloride
D000068736	Duloxetine Hydrochloride
D000078785	Mirtazapine
D004155	Diphenhydramine
D014196	Trazodone
D011224	Prazosin

Ancestor Terms

ID	Term
D037001	Directive Counseling
D003376	Counseling
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities
D006296	Health Services
D005159	Health Care Facilities Workforce and Services
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D010091	Oximes
D006898	Hydroxylamines
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D015057	1-Naphthylamine
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D011083	Polycyclic Compounds
D009570	Nitriles
D001572	Benzofurans
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003511	Cyclohexanols
D000441	Hexanols
D005233	Fatty Alcohols
D000438	Alcohols
D010627	Phenethylamines
D005021	Ethylamines
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D008055	Lipids
D013876	Thiophenes
D013457	Sulfur Compounds
D003984	Dibenzazepines
D006575	Heterocyclic Compounds, 3-Ring
D001559	Benzhydryl Compounds
D001555	Benzene Derivatives
D010879	Piperazines
D011728	Pyridones
D011725	Pyridines
D011799	Quinazolines

Units	Counts
Participants	OG000265 OG001370

Units	Counts
Participants	OG000265 OG001370

Units	Counts
Participants	OG000265 OG001370

Units	Counts
Participants	OG000265 OG001370

Units	Counts
Participants	OG000265 OG001370