Overview

This trial is active, not recruiting.

Conditions posttraumatic stress disorder, depression, alcohol-related disorders, suicidal ideation, substance-related disorders, mild cognitive impairment, quality of life
Treatments motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, care management
Sponsor University of Washington
Start date February 2015
End date August 2015
Trial size 80 participants
Trial identifier NCT02335125, UH2MH106338

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 comorbidity.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose health services research
Arm
(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 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
(No Intervention)
Only standard care practices will be administered to this arm.
(No Intervention)
Staff at a site who work on the protocol will also be consented into the study as participants in order to complete an organizational survey.
(No Intervention)
Individuals acting in the protocol as care managers will also be consented into the study as participants in order to complete an organizational survey, an assessment on understanding of PTSD screening and intervening, standardized patient interviews, and an exit interview.

Primary Outcomes

Measure
Change from Baseline PTSD Checklist Civilian at 1 Month
time frame: Baseline and 1-month
Change from Baseline Alcohol Use Disorders Identification at 1 Month
time frame: Baseline and 1-month
Change from Patient Health Questionnaire 9 item Depression Scale at 1 Month
time frame: Baseline and 1-month

Secondary Outcomes

Measure
SF-12/36
time frame: Baseline and 1-month
Patient Health Questionnaire 9 item Depression
time frame: Baseline and 1-month
Single Item Drug Use
time frame: Baseline and 1-month
Cognitive Impairment Scale
time frame: Baseline and 1-month

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Inpatient/Emergency Admission for traumatic injury Exclusion Criteria: - Non-English speaking - Self-inflicted injury - Actively psychotic - Incarcerated or in custody

Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Washington.