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

Depression Clinical Trial

— TSOS6  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335125
• Other study ID #: STUDY00010782
• Secondary ID: UH2MH106338
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inpatient/Emergency Admission for traumatic injury

Exclusion Criteria:

• Non-English speaking

• Self-inflicted injury

• Actively psychotic

• Incarcerated or in custody

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Cognitive Dysfunction
• Depression
• Disease
• Mild Cognitive Impairment
• Posttraumatic Stress Disorder
• Quality of Life
• Stress Disorders, Post-Traumatic
• Substance-Related Disorders
• Suicidal Ideation

Intervention

Behavioral:
• Motivational Interviewing

• Cognitive Behavioral Therapy Elements

Drug:
• Psychotropic Drugs

Other:
• Care Management

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Washington	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chronic Medical Condition ICD-9 Definition	Moderating Variable	Baseline
Other	Traumatic Brain Injury Status ICD-9 Definition	Moderating Variable	Baseline
Primary	Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month	The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.	Baseline and 1-month
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.	Baseline and 1-month
Primary	Change From Patient Health Questionnaire 9 Item Depression Scale at 1 Month	The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome.	Baseline and 1-month
Secondary	Change in Functional Status	The investigators will use the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.	Baseline and 1-month
Secondary	Patient Health Questionnaire Item 9 Suicide Question	Item 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome.	Baseline and 1-month
Secondary	Number of Participants Endorsing a Single Item That Assesses Drug Use	Single items that assess drug use across multiple substances (e.g., Cocaine, Prescription Opiates). Single item self-report dichotomized as none versus at least monthly use.	Baseline and 1-month
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.	Baseline and 1-month