Depression Clinical Trial
— TSOS6Official title:
A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot
Verified date | September 2020 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
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) |
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 |
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