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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00013928 | Other Identifier | Medical University of South Carolina IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: PE + TAU | Experimental | Prolonged Exposure Therapy +Treatment As Usual |
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| Arm 2: Usual Treatment | Active Comparator | Treatment As Usual |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Exposure for PTSD (PE) + Treatment as Usual (TAU) | Behavioral | 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual |
|
| Measure | Description | Time Frame |
|---|---|---|
| Posttraumatic Stress Disorder (PTSD) Checklist (PCL) | The PTSD Checklist (PCL) is a 17-item self-report measure of PTSD symptoms based on DSM-IV criteria. Total scores on the PCL were used, and total scores range from 17 to 85 with higher scores indicative of greater PTSD severity. | pre to post treatment (12 weeks) |
| Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) | The Clinician Administered PTSD (Posttraumatic Stress Disorder; PTSD) Scale (CAPS) is a 30-item structured interview that corresponds to DSM-IV criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assess symptoms over the past week/month. The CAPS was used to measure current PTSD (yes/no diagnosis) as well as total PTSD severity (scores range 0-136, with higher scores indicative of more severe PTSD). | pre to post treatment (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) | The Beck Depression Inventory-II is a 21 item measure of depressive severity. Total BDI-II scores were used. Scores on the BDI-II range from 0 to 63 with higher scores indicative of greater symptom severity. | pre to post treatment (12 weeks) |
| Brief Psychiatric Rating Scale-Extended (BPRS-E) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anouk L Grubaugh, PhD MA BS | Ralph H. Johnson VA Medical Center, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5799 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22884217 | Result | Grubaugh AL, Tuerk PW, Egede LE, Frueh BC. Perceptions of PTSD research participation among patients with severe mental illness. Psychiatry Res. 2012 Dec 30;200(2-3):1071-3. doi: 10.1016/j.psychres.2012.07.039. Epub 2012 Aug 9. | |
| 27863313 | Result | Brown WJ, Wilkerson AK, Milanak ME, Tuerk PW, Uhde TW, Cortese BM, Grubaugh AL. An examination of sleep quality in veterans with a dual diagnosis of PTSD and severe mental illness. Psychiatry Res. 2017 Jan;247:15-20. doi: 10.1016/j.psychres.2016.07.062. Epub 2016 Sep 30. |
| Label | URL |
|---|---|
| pubmed | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1: PE + TAU | Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual |
| FG001 | Arm 2: Usual Treament |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Treatment As Usual (TAU) | Behavioral | Treatment as usual (TAU) will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling |
|
The Brief Psychiatric Rating Scale-Extended (BPRS-E) is a 24 item measure of 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. Total BPRS scores were used and can range from 24 (score of 1 on all items, symptom not present) to 168 (score of 7 on all items, extremely severe). |
| pre to post treatment (12 weeks) |
| Veterans SF 12 Health Survey (SF-12) | 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 was used to track changes in general mental [MCS mental component score) and physical health (PCS physical component score) functioning. Scores on the SF-12 scales range from 0 to 100 once converted and higher scores are indicative of better mental and physical health. The MCS score was used in the current analyses.](streamdown:incomplete-link) | pre to post treatment (12 weeks) |
| Pittsburgh Seep Quality Index | The Pittsburgh Sleep Quality Index (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 ratings of 5 or higher indicative of poor sleep quality. Item 9, assessing overall quality of sleep, was used in current analyses. Scores on this item range from 0 to 3, with higher scores indicative of worse sleep quality. | pre to post treatment (12 weeks) |
| 26797658 | Result | Grubaugh AL, Clapp JD, Frueh BC, Tuerk PW, Knapp RG, Egede LE. Open trial of exposure therapy for PTSD among patients with severe and persistent mental illness. Behav Res Ther. 2016 Mar;78:1-12. doi: 10.1016/j.brat.2015.12.006. Epub 2015 Dec 28. |
| pubmed | View source |
| pubmed | View source |
Treatment As Usual
Treatment As Usual: TAU will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: PE + TAU | Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual |
| BG001 | Arm 2: Usual Treament | Treatment As Usual Treatment As Usual: TAU will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Posttraumatic Stress Disorder (PTSD) Checklist (PCL) | The PTSD Checklist (PCL) is a 17-item self-report measure of PTSD symptoms based on DSM-IV criteria. Total scores on the PCL were used, and total scores range from 17 to 85 with higher scores indicative of greater PTSD severity. | Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up). | Posted | Mean | Standard Error | score on a scale | pre to post treatment (12 weeks) |
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| Primary | Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) | The Clinician Administered PTSD (Posttraumatic Stress Disorder; PTSD) Scale (CAPS) is a 30-item structured interview that corresponds to DSM-IV criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assess symptoms over the past week/month. The CAPS was used to measure current PTSD (yes/no diagnosis) as well as total PTSD severity (scores range 0-136, with higher scores indicative of more severe PTSD). | Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up). | Posted | Mean | Standard Error | score on a scale | pre to post treatment (12 weeks) |
|
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| Secondary | Beck Depression Inventory-II (BDI-II) | The Beck Depression Inventory-II is a 21 item measure of depressive severity. Total BDI-II scores were used. Scores on the BDI-II range from 0 to 63 with higher scores indicative of greater symptom severity. | Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up). | Posted | Mean | Standard Error | score on a scale | pre to post treatment (12 weeks) |
|
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| Secondary | Brief Psychiatric Rating Scale-Extended (BPRS-E) | The Brief Psychiatric Rating Scale-Extended (BPRS-E) is a 24 item measure of 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. Total BPRS scores were used and can range from 24 (score of 1 on all items, symptom not present) to 168 (score of 7 on all items, extremely severe). | Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up). | Posted | Mean | Standard Error | score on a scale | pre to post treatment (12 weeks) |
|
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| Secondary | Veterans SF 12 Health Survey (SF-12) | 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 was used to track changes in general mental [MCS mental component score) and physical health (PCS physical component score) functioning. Scores on the SF-12 scales range from 0 to 100 once converted and higher scores are indicative of better mental and physical health. The MCS score was used in the current analyses.](streamdown:incomplete-link) | Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up). | Posted | Mean | Standard Error | score on a scale | pre to post treatment (12 weeks) |
|
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| Secondary | Pittsburgh Seep Quality Index | The Pittsburgh Sleep Quality Index (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 ratings of 5 or higher indicative of poor sleep quality. Item 9, assessing overall quality of sleep, was used in current analyses. Scores on this item range from 0 to 3, with higher scores indicative of worse sleep quality. | Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up). | Posted | Mean | Standard Error | score on a scale | pre to post treatment (12 weeks) |
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| Post-Hoc | Hamilton Depression Scale | The Hamilton Depression Scale (HAM-D) is a 17, 21, or 24 item measure of depression severity. In the 17-item version, which was used, nine of the items are scored on a five-point scale, ranging from 0 to 4; and 8 of the items are scored on a 3-point scale, ranging from 0 to 2. Total scores on the HAM-D are summed and range from 0-53 with higher scores reflective of more severe depressive symptoms. | A subset of participants were administered the HAM-D as an exploratory analysis. | Posted | Mean | Standard Error | score on a scale | pre to post treatment (12 weeks) |
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| Post-Hoc | Psychotic Symptom Rating Scales | The Psychotic Symptom Rating Scales (PSYRATS) is an instrument designed to quantify the severity of delusions and hallucinations. The measure has 17 items scored from 0 to 4 (11 items measure auditory hallucinations; 6 items measure delusions). Scores range from 0 to 68 and are summed with higher scores reflective of more severe psychosis. | A subset of participants were administered the HAM-D as an exploratory analysis. | Posted | Mean | Standard Error | score on a scale | pre to post treatment (12 weeks) |
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| Post-Hoc | The Difficulties in Emotion Regulation Scale | The Difficulties in Emotion Regulation Scale (DERS) is a 36-item self-report questionnaire designed to assess multiple aspects of emotion dysregulation. It yields a total score as well as 6 scale scores: Non-acceptance of emotional responses; Difficulties engaging in goal directed behavior; Impulse control difficulties; Lack of emotional awareness; Limited access to emotion regulation strategies; and Lack of emotional clarity. Item scores range from 1 "almost never" to 5 "almost always" with total summed scores ranging from 36 to 180, and higher scores reflective of greater emotion regulation difficulties. | The DERS was added at a later time as an exploratory variable. | Posted | Mean | Standard Deviation | score on a scale | baseline |
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| Post-Hoc | Young Mania Scale | The Young Mania Rating Scale (YMRS) is a commonly used measure to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition. Additional information is based upon clinical observations made during the course of the clinical interview. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Scores range from 0 to 60 and are summed with higher scores reflective of higher symptom severity. | A subset of participants were administered the HAM-D as an exploratory analysis. | Posted | Mean | Standard Error | units on a scale | pre to post treatment (12 weeks) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: PE + TAU | Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual | 1 | 68 | 0 | 68 | 0 | 68 |
| EG001 | Arm 2: Usual Treament | Treatment As Usual Treatment As Usual: TAU will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling | 1 | 66 | 1 | 66 | 0 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| psychiatric hospitalization | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anouk L. Grubaugh | Charleston VAMC | 843-789-5853 | grubaugh@musc.edu |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D003866 | Depressive Disorder |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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