Trial Outcomes & Findings for PTSD (PostTraumatic Stress Disorder) Services for Veterans With SMI (Severe Mental Illness) (NCT NCT01542229)

NCT ID: NCT01542229

Last Updated: 2019-07-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 134 participants
• Primary outcome timeframe: pre to post treatment (12 weeks)
• Results posted on: 2019-07-15

Participant Flow

Participant milestones

Measure	Arm 1: PE + TAU Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	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
Overall Study STARTED	68	66
Overall Study COMPLETED	45	30
Overall Study NOT COMPLETED	23	36

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Arm 1: PE + TAU n=68 Participants Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	Arm 2: Usual Treament n=66 Participants 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	Total n=134 Participants Total of all reporting groups
Age, Continuous	43.33 years STANDARD_DEVIATION 12.85 • n=5 Participants	46.51 years STANDARD_DEVIATION 12.10 • n=7 Participants	46.01 years STANDARD_DEVIATION 12.54 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	52 Participants n=7 Participants	102 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm 1: PE + TAU n=35 Participants Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	Arm 2: Usual Treament n=42 Participants 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
Posttraumatic Stress Disorder (PTSD) Checklist (PCL) pre treatment (tx) mean	66.94 score on a scale Standard Error 1.71	66.33 score on a scale Standard Error 1.56
Posttraumatic Stress Disorder (PTSD) Checklist (PCL) post treatment (tx) mean	51.20 score on a scale Standard Error 2.49	60.60 score on a scale Standard Error 2.27

PRIMARY outcome

Timeframe: 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).

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).

Outcome measures

Measure	Arm 1: PE + TAU n=33 Participants Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	Arm 2: Usual Treament n=45 Participants 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
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) pre treatment (tx) mean	69.00 score on a scale Standard Error 2.87	62.91 score on a scale Standard Error 2.45
Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) post treatment (tx) mean	49.42 score on a scale Standard Error 4.42	68.42 score on a scale Standard Error 3.78

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm 1: PE + TAU n=30 Participants Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	Arm 2: Usual Treament n=35 Participants 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
Beck Depression Inventory-II (BDI-II) pre treatmetn (tx) mean	37.26 score on a scale Standard Error 2.08	31.54 score on a scale Standard Error 1.83
Beck Depression Inventory-II (BDI-II) post treatment (tx) mean	26.52 score on a scale Standard Error 2.89	30.00 score on a scale Standard Error 2.53

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Measure	Arm 1: PE + TAU n=32 Participants Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	Arm 2: Usual Treament n=45 Participants 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
Brief Psychiatric Rating Scale-Extended (BPRS-E) pre treatment (tx) mean	47.34 score on a scale Standard Error 2.11	44.87 score on a scale Standard Error 1.78
Brief Psychiatric Rating Scale-Extended (BPRS-E) post treatment (tx) mean	33.72 score on a scale Standard Error 1.55	35.29 score on a scale Standard Error 1.31

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm 1: PE + TAU n=30 Participants Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	Arm 2: Usual Treament n=39 Participants 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
Veterans SF 12 Health Survey (SF-12) pre treatment (tx) mean	36.69 score on a scale Standard Error 2.10	42.48 score on a scale Standard Error 1.78
Veterans SF 12 Health Survey (SF-12) post treatment (tx) mean	44.31 score on a scale Standard Error 2.14	42.70 score on a scale Standard Error 1.82

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Measure	Arm 1: PE + TAU n=32 Participants Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	Arm 2: Usual Treament n=42 Participants 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
Pittsburgh Seep Quality Index post treatment (tx) mean	2.00 score on a scale Standard Error .148	2.29 score on a scale Standard Error .129
Pittsburgh Seep Quality Index pre treatment (tx) mean	2.47 score on a scale Standard Error .119	2.45 score on a scale Standard Error .103

POST_HOC outcome

Timeframe: pre to post treatment (12 weeks)

Population: A subset of participants were administered the HAM-D as an exploratory analysis.

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.

Outcome measures

Measure	Arm 1: PE + TAU n=26 Participants Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	Arm 2: Usual Treament n=43 Participants 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
Hamilton Depression Scale pre treatment (tx) mean	18.15 score on a scale Standard Error 1.20	17.56 score on a scale Standard Error .93
Hamilton Depression Scale post treatment (tx) mean	10.23 score on a scale Standard Error 1.35	14.23 score on a scale Standard Error 1.05

POST_HOC outcome

Timeframe: pre to post treatment (12 weeks)

Population: A subset of participants were administered the HAM-D as an exploratory analysis.

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.

Outcome measures

Measure	Arm 1: PE + TAU n=4 Participants Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	Arm 2: Usual Treament n=5 Participants 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
Psychotic Symptom Rating Scales pre treatment (tx) mean	30.00 score on a scale Standard Error 5.40	11.60 score on a scale Standard Error 4.83
Psychotic Symptom Rating Scales post treatment (tx) mean	23.00 score on a scale Standard Error 8.96	16.60 score on a scale Standard Error 8.02

POST_HOC outcome

Timeframe: baseline

Population: The DERS was added at a later time as an exploratory variable.

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.

Outcome measures

Measure	Arm 1: PE + TAU n=25 Participants Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	Arm 2: Usual Treament n=26 Participants 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
The Difficulties in Emotion Regulation Scale	119.00 score on a scale Standard Deviation 26.08	114.15 score on a scale Standard Deviation 26.14

POST_HOC outcome

Timeframe: pre to post treatment (12 weeks)

Population: A subset of participants were administered the HAM-D as an exploratory analysis.

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.

Outcome measures

Measure	Arm 1: PE + TAU n=15 Participants Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	Arm 2: Usual Treament n=15 Participants 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
Young Mania Scale pre treatment (tx) mean	5.10 units on a scale Standard Error 1.54	6.91 units on a scale Standard Error 1.47
Young Mania Scale post treatment (tx) mean	3.60 units on a scale Standard Error 1.96	2.00 units on a scale Standard Error 1.86

Adverse Events

Arm 1: PE + TAU

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Arm 2: Usual Treament

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Arm 1: PE + TAU n=68 participants at risk Prolonged Exposure Therapy +Treatment As Usual PE + TAU: 12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual	Arm 2: Usual Treament n=66 participants at risk 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
General disorders psychiatric hospitalization	0.00% 0/68	1.5% 1/66 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anouk L. Grubaugh

Charleston VAMC

Phone: 843-789-5853

Email: grubaugh@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place