N/A N=40 Randomized Single-blind Health Services Research

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

Posttraumatic Stress Disorder · Depression · Alcohol-Related Disorders · Suicidal Ideation · Substance-Related Disorders

Bottom Line

View on ClinicalTrials.gov: NCT02335125 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Sep 2020

Primary outcome: Primary: Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month — 1.30; 5.04 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Motivational Interviewing (Behavioral); Cognitive Behavioral Therapy Elements (Behavioral); Psychotropic Drugs (Drug); Care Management (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month	1.30; 5.04	—
PRIMARY Change From Baseline Alcohol Use Disorders Identification at 1 Month	-1.36; -2.31	—
PRIMARY Change From Patient Health Questionnaire 9 Item Depression Scale at 1 Month	1.27; 0.28	—
SECONDARY Change in Functional Status	48.2; 46.5; 30.1; 33.0	—
SECONDARY Patient Health Questionnaire Item 9 Suicide Question	3; 2; 4; 6	—
SECONDARY Number of Participants Endorsing a Single Item That Assesses Drug Use	12; 10; 15; 13	—
SECONDARY Cognitive Impairment Scale	16.3; 16.9; 16.3; 15.9	—

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.

Eligibility Criteria

Inclusion Criteria

Inpatient/Emergency Admission for traumatic injury

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02335125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.