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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-03

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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The overarching aim of this proposal is to compare the efficacy of Prolonged Exposure for posttraumatic stress disorder (PTSD) plus treatment as usual (PE+TAU) relative to treatment as usual (TAU) alone using a randomized, between groups, repeated measures design. One hundred fifty six (156) ethnically/racially diverse male and female Veterans with posttraumatic stress disorder (PTSD) and severe mental illness (SMI) will be recruited from the Charleston VA and affiliated Community Based Outpatient Clinics (CBOCs) during the study time frame. For the investigators' study purposes, severe mental illness (SMI) is defined as (1) the presence of a past year Diagnostic Statistical Manual (DSM-IV) Axis I diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or severe depression (2) resulting in persistent impairment in self-care, work, or social functioning. Veterans will be randomized 1:1 to one of two conditions: PE+TAU or TAU. The active intervention phase is 12 weeks. Veterans randomized to treatment as usual (TAU) will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling and Veterans randomized to prolonged exposure (PE) plus treatment as usual (TAU) will receive 12 weekly sessions of prolonged exposure (PE) in addition to treatment as usual (TAU). All participants will be assessed at baseline, 6 weeks, post-treatment, and at 3 and 6 months. Additionally, they will complete two self report forms during sessions 3, 6, and 9.

Conditions

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Post Traumatic Stress Disorder Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depression

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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Arm 1: PE + TAU

Prolonged Exposure Therapy +Treatment As Usual

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Arm 2: Usual Treatment

Treatment As Usual

Group Type ACTIVE_COMPARATOR

Treatment As Usual (TAU)

Intervention Type BEHAVIORAL

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

Interventions

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

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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Posttraumatic Stress Disorder (PTSD) on the Clinician Administered PTSD Scale (CAPS; Blake et al., 1990);
* A confirmed diagnosis of a psychotic disorder, bipolar disorder, or severe unipolar depression on the Mini Neuropsychiatric Interview (MINI; Sheehan et al., 1998).

Exclusion Criteria

* Having a household member who is already enrolled in the study;
* Active psychosis, mania, or dementia at screening;
* Suicidal ideation with clear intent;
* Current substance dependence; and
* Concurrent enrollment in another clinical trial for PTSD or depression.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No