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

NCT ID: NCT02335125

Last Updated: 2020-09-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Posttraumatic Stress Disorder Depression Alcohol-Related Disorders Suicidal Ideation Substance-Related Disorders Mild Cognitive Impairment Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Motivational Interviewing

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy Elements

Intervention Type BEHAVIORAL

Psychotropic Drugs

Intervention Type DRUG

Care Management

Intervention Type OTHER

Usual Care

Only standard care practices will be administered to this arm.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Motivational Interviewing

Intervention Type BEHAVIORAL

Cognitive Behavioral Therapy Elements

Intervention Type BEHAVIORAL

Psychotropic Drugs

Intervention Type DRUG

Care Management

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Inpatient/Emergency Admission for traumatic injury

Exclusion Criteria

* Non-English speaking
* Self-inflicted injury
* Actively psychotic
* Incarcerated or in custody
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Douglas Zatzick

Professor, Psychiatry & Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas Zatzick, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Other Identifiers

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UH2MH106338

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00010782

Identifier Type: -

Identifier Source: org_study_id

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