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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02335125

Acronym

TSOS6

Enrollment

Registered

2015-01-09

Start date

2015-02-28

Completion date

2016-08-31

Last updated

2020-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder, Depression, Alcohol-Related Disorders, Suicidal Ideation, Substance-Related Disorders, Mild Cognitive Impairment, Quality of Life

Brief summary

The goal of this pilot study is to develop and implement a larger scale, multi-site stepped collaborative care trial that targets injured patients with presentations of posttraumatic stress disorder (PTSD) and related comorbidities.

Interventions

BEHAVIORALMotivational Interviewing

BEHAVIORALCognitive Behavioral Therapy Elements

DRUGPsychotropic Drugs

OTHERCare Management

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Inpatient/Emergency Admission for traumatic injury

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline Alcohol Use Disorders Identification at 1 Month	Baseline and 1-month	The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.
Change From Patient Health Questionnaire 9 Item Depression Scale at 1 Month	Baseline and 1-month	The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome.
Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month	Baseline and 1-month	The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.

Secondary

Measure	Time frame	Description
Cognitive Impairment Scale	Baseline and 1-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.
Number of Participants Endorsing a Single Item That Assesses Drug Use	Baseline and 1-month	Single items that assess drug use across multiple substances (e.g., Cocaine, Prescription Opiates). Single item self-report dichotomized as none versus at least monthly use.
Change in Functional Status	Baseline and 1-month	The investigators will use the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.
Patient Health Questionnaire Item 9 Suicide Question	Baseline and 1-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.

Other

Measure	Time frame	Description
Chronic Medical Condition ICD-9 Definition	Baseline	Moderating Variable
Traumatic Brain Injury Status ICD-9 Definition	Baseline	Moderating Variable

Participant flow

Participants by arm

Arm	Count
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 TBI and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, medication, and psychotherapy elements. Motivational Interviewing Cognitive Behavioral Therapy Elements Psychotropic Drugs Care Management	20
Usual Care Only standard care practices will be administered to this arm.	20
Total	40

Baseline characteristics

Characteristic	Intervention	Usual Care	Total
Age, Categorical <=18 years	1 Participants	2 Participants	3 Participants
Age, Categorical >=65 years	1 Participants	5 Participants	6 Participants
Age, Categorical Between 18 and 65 years	18 Participants	13 Participants	31 Participants
Age, Continuous	43.8 years STANDARD_DEVIATION 18.1	48.4 years STANDARD_DEVIATION 18.9	46.0 years STANDARD_DEVIATION 18.4
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	2 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants	18 Participants	37 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	3 Participants	4 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) More than one race	1 Participants	2 Participants	3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	3 Participants	4 Participants
Race (NIH/OMB) White	16 Participants	11 Participants	27 Participants
Sex: Female, Male Female	6 Participants	7 Participants	13 Participants
Sex: Female, Male Male	14 Participants	13 Participants	27 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 20	0 / 20
other Total, other adverse events	0 / 20	0 / 20
serious Total, serious adverse events	1 / 20	0 / 20

Outcome results

Primary

Change From Baseline Alcohol Use Disorders Identification at 1 Month

The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.