Bipolar Disorder, Major Depression, Post Traumatic Stress Disorder, Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Post Traumatic Stress Disorder, Severe Mental Illness
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.
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 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.
Interventions
BEHAVIORALProlonged Exposure for PTSD (PE) + Treatment as Usual (TAU)
12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual
BEHAVIORALTreatment As Usual (TAU)
Treatment as usual (TAU) will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Posttraumatic Stress Disorder (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Stress Disorder (PTSD) Checklist (PCL) | pre to post treatment (12 weeks) | 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. |
| Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) | pre to post treatment (12 weeks) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory-II (BDI-II) | pre to post treatment (12 weeks) | 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. |
| Brief Psychiatric Rating Scale-Extended (BPRS-E) | pre to post treatment (12 weeks) | 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). |
| Veterans SF 12 Health Survey (SF-12) | pre to post treatment (12 weeks) | 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. |
| Pittsburgh Seep Quality Index | pre to post treatment (12 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: PE + TAU Prolonged Exposure Therapy +Treatment As Usual
PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual | 68 |
| 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 | 66 |
| Total | 134 |
Baseline characteristics
| Characteristic | Arm 1: PE + TAU | Arm 2: Usual Treament | Total |
|---|---|---|---|
| Age, Continuous | 43.33 years STANDARD_DEVIATION 12.85 | 46.51 years STANDARD_DEVIATION 12.1 | 46.01 years STANDARD_DEVIATION 12.54 |
| Sex: Female, Male Female | 18 Participants | 14 Participants | 32 Participants |
| Sex: Female, Male Male | 50 Participants | 52 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 68 | 1 / 66 |
| other Total, other adverse events | 0 / 68 | 0 / 66 |
| serious Total, serious adverse events | 0 / 68 | 1 / 66 |
Outcome results
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).
Time frame: pre to post treatment (12 weeks)
Population: Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PE + TAU | Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) | pre treatment (tx) mean | 69.00 score on a scale | Standard Error 2.87 |
| Arm 1: PE + TAU | Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) | post treatment (tx) mean | 49.42 score on a scale | Standard Error 4.42 |
| Arm 2: Usual Treament | Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) | pre treatment (tx) mean | 62.91 score on a scale | Standard Error 2.45 |
| Arm 2: Usual Treament | Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) | post treatment (tx) mean | 68.42 score on a scale | Standard Error 3.78 |
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.
Time frame: pre to post treatment (12 weeks)
Population: Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PE + TAU | Posttraumatic Stress Disorder (PTSD) Checklist (PCL) | pre treatment (tx) mean | 66.94 score on a scale | Standard Error 1.71 |
| Arm 1: PE + TAU | Posttraumatic Stress Disorder (PTSD) Checklist (PCL) | post treatment (tx) mean | 51.20 score on a scale | Standard Error 2.49 |
| Arm 2: Usual Treament | Posttraumatic Stress Disorder (PTSD) Checklist (PCL) | pre treatment (tx) mean | 66.33 score on a scale | Standard Error 1.56 |
| Arm 2: Usual Treament | Posttraumatic Stress Disorder (PTSD) Checklist (PCL) | post treatment (tx) mean | 60.60 score on a scale | Standard Error 2.27 |
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.
Time frame: pre to post treatment (12 weeks)
Population: Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PE + TAU | Beck Depression Inventory-II (BDI-II) | pre treatmetn (tx) mean | 37.26 score on a scale | Standard Error 2.08 |
| Arm 1: PE + TAU | Beck Depression Inventory-II (BDI-II) | post treatment (tx) mean | 26.52 score on a scale | Standard Error 2.89 |
| Arm 2: Usual Treament | Beck Depression Inventory-II (BDI-II) | pre treatmetn (tx) mean | 31.54 score on a scale | Standard Error 1.83 |
| Arm 2: Usual Treament | Beck Depression Inventory-II (BDI-II) | post treatment (tx) mean | 30.00 score on a scale | Standard Error 2.53 |
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).
Time frame: pre to post treatment (12 weeks)
Population: Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PE + TAU | Brief Psychiatric Rating Scale-Extended (BPRS-E) | pre treatment (tx) mean | 47.34 score on a scale | Standard Error 2.11 |
| Arm 1: PE + TAU | Brief Psychiatric Rating Scale-Extended (BPRS-E) | post treatment (tx) mean | 33.72 score on a scale | Standard Error 1.55 |
| Arm 2: Usual Treament | Brief Psychiatric Rating Scale-Extended (BPRS-E) | pre treatment (tx) mean | 44.87 score on a scale | Standard Error 1.78 |
| Arm 2: Usual Treament | Brief Psychiatric Rating Scale-Extended (BPRS-E) | post treatment (tx) mean | 35.29 score on a scale | Standard Error 1.31 |
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.
Time frame: pre to post treatment (12 weeks)
Population: Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PE + TAU | Pittsburgh Seep Quality Index | post treatment (tx) mean | 2.00 score on a scale | Standard Error 0.148 |
| Arm 1: PE + TAU | Pittsburgh Seep Quality Index | pre treatment (tx) mean | 2.47 score on a scale | Standard Error 0.119 |
| Arm 2: Usual Treament | Pittsburgh Seep Quality Index | pre treatment (tx) mean | 2.45 score on a scale | Standard Error 0.103 |
| Arm 2: Usual Treament | Pittsburgh Seep Quality Index | post treatment (tx) mean | 2.29 score on a scale | Standard Error 0.129 |
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.
Time frame: pre to post treatment (12 weeks)
Population: Variability in sample size for primary outcomes pre to post due to attrition (i.e., treatment dropout and/or lost to follow-up).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PE + TAU | Veterans SF 12 Health Survey (SF-12) | pre treatment (tx) mean | 36.69 score on a scale | Standard Error 2.1 |
| Arm 1: PE + TAU | Veterans SF 12 Health Survey (SF-12) | post treatment (tx) mean | 44.31 score on a scale | Standard Error 2.14 |
| Arm 2: Usual Treament | Veterans SF 12 Health Survey (SF-12) | pre treatment (tx) mean | 42.48 score on a scale | Standard Error 1.78 |
| Arm 2: Usual Treament | Veterans SF 12 Health Survey (SF-12) | post treatment (tx) mean | 42.70 score on a scale | Standard Error 1.82 |
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.
Time frame: pre to post treatment (12 weeks)
Population: A subset of participants were administered the HAM-D as an exploratory analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PE + TAU | Hamilton Depression Scale | pre treatment (tx) mean | 18.15 score on a scale | Standard Error 1.2 |
| Arm 1: PE + TAU | Hamilton Depression Scale | post treatment (tx) mean | 10.23 score on a scale | Standard Error 1.35 |
| Arm 2: Usual Treament | Hamilton Depression Scale | pre treatment (tx) mean | 17.56 score on a scale | Standard Error 0.93 |
| Arm 2: Usual Treament | Hamilton Depression Scale | post treatment (tx) mean | 14.23 score on a scale | Standard Error 1.05 |
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.
Time frame: pre to post treatment (12 weeks)
Population: A subset of participants were administered the HAM-D as an exploratory analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PE + TAU | Psychotic Symptom Rating Scales | pre treatment (tx) mean | 30.00 score on a scale | Standard Error 5.4 |
| Arm 1: PE + TAU | Psychotic Symptom Rating Scales | post treatment (tx) mean | 23.00 score on a scale | Standard Error 8.96 |
| Arm 2: Usual Treament | Psychotic Symptom Rating Scales | pre treatment (tx) mean | 11.60 score on a scale | Standard Error 4.83 |
| Arm 2: Usual Treament | Psychotic Symptom Rating Scales | post treatment (tx) mean | 16.60 score on a scale | Standard Error 8.02 |
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.
Time frame: baseline
Population: The DERS was added at a later time as an exploratory variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: PE + TAU | The Difficulties in Emotion Regulation Scale | 119.00 score on a scale | Standard Deviation 26.08 |
| Arm 2: Usual Treament | The Difficulties in Emotion Regulation Scale | 114.15 score on a scale | Standard Deviation 26.14 |
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.
Time frame: pre to post treatment (12 weeks)
Population: A subset of participants were administered the HAM-D as an exploratory analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1: PE + TAU | Young Mania Scale | pre treatment (tx) mean | 5.10 units on a scale | Standard Error 1.54 |
| Arm 1: PE + TAU | Young Mania Scale | post treatment (tx) mean | 3.60 units on a scale | Standard Error 1.96 |
| Arm 2: Usual Treament | Young Mania Scale | pre treatment (tx) mean | 6.91 units on a scale | Standard Error 1.47 |
| Arm 2: Usual Treament | Young Mania Scale | post treatment (tx) mean | 2.00 units on a scale | Standard Error 1.86 |