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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01542229
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : January 16, 2018
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depression Behavioral: PE + TAU Behavioral: Treatment As Usual Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Improving PTSD Service Delivery for Veterans With Severe Mental Illness
Actual Study Start Date : May 3, 2012
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Arm Intervention/treatment
Experimental: Arm 1: PE + TAU
Prolonged Exposure Therapy +Treatment As Usual
Behavioral: PE + TAU
12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual

Active Comparator: Arm 2: Usual Treament
Treatment As Usual
Behavioral: Treatment As Usual
TAU will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling

Primary Outcome Measures :
  1. PTSD (Posttraumatic stress disorder) Checklist (PCL) [ Time Frame: 1 Year ]
    The PTSD (Posttraumatic stress disorder) Checklist (PCL) is a 17-item self-report measure of PTSD symptoms based on DSM-IV criteria. Total scores on the PCL range from 17 to 85 and higher scores reflect greater PTSD severity.

Secondary Outcome Measures :
  1. Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) [ Time Frame: Baseline ]
    The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week.

  2. Beck Depression Inventory-II (BDI-II) [ Time Frame: 1 Year ]
    Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.

  3. Young Mania Rating Scale (YMRS) [ Time Frame: 1 Year ]
    Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire used to measure the severity of manic episodes in patients.

  4. Brief Psychiatric Rating Scale-Extended (BPRS-E) [ Time Frame: 1Year ]
    Brief Psychiatric Rating Scale-Extended (BPRS-E) measures psychopathology across several dimensions (i.e., delusions, motor hyperactivity, withdrawal and blunted affect, self-neglect, etc.) and is a commonly used measure for severely and persistently ill patient populations.

  5. Veterans SF 12 Health Survey (SF-12) [ Time Frame: 1 Year ]
    The Veterans SF 12 Health Survey (SF-12) is a valid and reliable instrument to measure quality of life and/or functional status in Veterans. The SF-12 will be used to track changes in general mental and physical health functioning (i.e., functional status or general health functioning

  6. Index of Functional Impairment (IFI) [ Time Frame: 1 Year ]
    The Index of Functional Impairment (IFI) is a self-report inventory of PTSD-related functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.

  7. Treatment Expectancy [ Time Frame: 1 Year ]
    Treatment Expectancy measure assesses for differences in outcome expectancy and treatment credibility and will be administered during the third session of treatment and again at post-treatment.

  8. Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS) [ Time Frame: post treatment (12 weeks) ]
    Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS) is 16-item measure, with a Likert scale response format, based on a general measure of patient satisfaction

  9. Reactions Related to PTSD Research Participation [ Time Frame: Up to 12 weeks ]
    Reactions Related to PTSD Research Participation survey which asks participants to rate on a 10-point scale how distressing, difficult, and confusing they found the research procedures; how satisfied they were with their participation; how worthwhile they thought the experience was; and how willing they would be to participate in a similar study in the future

  10. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 1 Year ]
    Commonly used observer-rated measure for depression. HAM-D is a 16-item measure that rates the severity of depression in patients who have been diagnosed with depression.

  11. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 1 Year ]
    The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.

  12. Clinical Global Impressions (CGI) [ Time Frame: 1 Year ]
    CGI scale is an index of overall clinical severity and improvement that is commonly used in clinical trials. The Severity and Global Improvement Subscales are each 7 point scales and are part of the ECDEU Assessment manual for Psychopharmacology.

  13. Combat Exposure Scale (CES) [ Time Frame: 1 Year ]
    CES is a 7-item self-report measure of combat exposure severity that ranges from 0 (no combat) to 41 (heavy combat) that has been found to have good psychometric qualities including high internal and test-retest reliability.

  14. Mini-International Neuropsychiatric Interview (MINI) [ Time Frame: 1 Year ]
    Is a brief structured interview that assesses the criteria for DSM-IV Axis I diagnoses. The MINI will be used to assess for a diagnosis of current depression and to screen for substance dependence.

  15. Reactions to Research Participation Questionnaire Revised (Newman et al., 2001) [ Time Frame: 1 Year ]
    It is a questionnaire that asks for participants opinion about what it was like participating in this study. It is a 23 question Likert scale design.

  16. psychotic Symptom Rating Scales (PSYRATS) [ Time Frame: 1 Year ]
    Two scales: one scale for auditory hallucinations and one scale for delusions. Each scale measures the presence and severity of a number of different dimensions of the psychotic symptoms in schizophrenia and psychosis.

  17. Hamilton Program for Schizophrenia Voices Questionnaire (HPS-VQ) [ Time Frame: 1 year ]
    13 item measure in which each of the first nine items are assigned scores on a five-point Likert scale from zero to four. The total score is intended to indicate the severity of auditory verbal hallucinations.

  18. PANAS-X [ Time Frame: 1 Year ]
    Consists of a number of words and phrases that describe different feelings and emotions. The PANAS-X assess the specific, distinguishable affective emotional states that emerge from within the broader general dimensions of positive and negative emotional experiences.

  19. Difficulties in Emotion Regulation Scale (DERS) [ Time Frame: 1 Year ]
    Is a brief, 36-item self-report questionnaire designed to assess multiple aspects of emotional dysregulation.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01542229

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United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Anouk L Grubaugh, PhD MA BS Ralph H. Johnson VA Medical Center, Charleston, SC

Additional Information:
Publications of Results:
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Responsible Party: VA Office of Research and Development Identifier: NCT01542229     History of Changes
Other Study ID Numbers: IIR 11-306
Pro00013928 ( Other Identifier: Medical University of South Carolina IRB )
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by VA Office of Research and Development:
Post Traumatic Stress Disorder
Severe Mental Illness

Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Bipolar Disorder
Stress Disorders, Post-Traumatic
Depressive Disorder, Major
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Trauma and Stressor Related Disorders
Bipolar and Related Disorders
Depressive Disorder
Mood Disorders
Pathologic Processes