PTSD (PostTraumatic Stress Disorder) Services for Veterans With SMI (Severe Mental Illness) (PTSD/SMI)
|ClinicalTrials.gov Identifier: NCT01542229|
Recruitment Status : Completed
First Posted : March 2, 2012
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment|
|Post Traumatic Stress Disorder Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depression||Behavioral: PE + TAU Behavioral: Treatment As Usual|
|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|
|Primary Completion Date :||December 31, 2016|
|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.
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|