PTSD (PostTraumatic Stress Disorder) Services for Veterans With SMI (Severe Mental Illness)
| Status: | Completed |
|---|---|
| Conditions: | Depression, Schizophrenia, Major Depression Disorder (MDD), Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/17/2018 |
| Start Date: | May 3, 2012 |
| End Date: | December 31, 2016 |
Improving PTSD Service Delivery for Veterans With Severe Mental Illness
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.
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.
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 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.
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 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.
Inclusion Criteria:
- Diagnosis of 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.
We found this trial at
1
site
Charleston, South Carolina 29401
Principal Investigator: Anouk L Grubaugh, PhD MA BS
Phone: 843-789-6664
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