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PTSD (PostTraumatic Stress Disorder) Services for Veterans With SMI (Severe Mental Illness)

NCT01542229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2019-07-15

Study results available
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Summary

As in the general population, there is no clear standard of care within Veterans Affairs Medical Centers for treating posttraumatic stress disorder (PTSD) among individuals with severe mental illness (SMI). This is a considerable issue because trauma, posttraumatic stress disorder (PTSD), and severe psychiatric comorbidity are particularly common among Veterans and this symptom presentation clearly exacerbates the overall course and severity of mental illness. This study is significant in that it proposes to establish the efficacy of a frontline exposure based intervention for posttraumatic stress disorder (PTSD), Prolonged Exposure, for improving critical clinical, quality of life, and cost outcomes among Veterans with severe mental illness (SMI) enrolled in VA healthcare. Collectively, it is anticipated that these data will establish a much needed clinical course of action for what is considered a vulnerable yet highly underserved patient population.

Conditions

Interventions

BEHAVIORAL

Prolonged Exposure for PTSD (PE) + Treatment as Usual (TAU)

12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual

BEHAVIORAL

Treatment As Usual (TAU)

Treatment as usual (TAU) will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Anouk L Grubaugh, PhD MA BS · Ralph H. Johnson VA Medical Center, Charleston, SC

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-03
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01542229 on ClinicalTrials.gov