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

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Depression; Alcohol-Related Disorders; Suicidal Ideation; Quality of Life; Substance-Related Disorders; Mild Cognitive Impairment
• Interventions: Behavioral: Motivational Interviewing; Behavioral: Cognitive Behavioral Therapy Elements; Drug: Psychotropic Drugs; Other: Care Management

• Registration Number: NCT02335125
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-09
• Study Start: 2015-02
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Results First Submitted: 2020-08-21
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Results First Posted: 2020-09-11
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Inpatient/Emergency Admission for traumatic injury

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Motivational Interviewing	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.
Intervention	Cognitive Behavioral Therapy Elements	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.
Intervention	Psychotropic Drugs	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.
Intervention	Care Management	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.

Primary Outcome Measures

Name	Time	Method
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.
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 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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.