PTSD (PostTraumatic Stress Disorder) Services for Veterans With SMI (Severe Mental Illness) (PTSD/SMI)
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|ClinicalTrials.gov Identifier: NCT01542229|
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : January 16, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01542229
|United States, South Carolina|
|Ralph H. Johnson VA Medical Center, Charleston, SC|
|Charleston, South Carolina, United States, 29401-5799|
|Principal Investigator:||Anouk L Grubaugh, PhD MA BS||Ralph H. Johnson VA Medical Center, Charleston, SC|