Trial Outcomes & Findings for Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders (NCT NCT01338506)
NCT ID: NCT01338506
Last Updated: 2020-02-11
Results Overview
The hypothesis is that COPE will significantly exceed the treatment as usual control group in reducing Change in Post-traumatic Stress Disorder symptoms as measured by a reduction of 25 points or more in scores for the Clinician Administered Post-traumatic Stress Disorder Scale (CAPS). A lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes. A negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes). Clinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms ≥80: extreme PTSD symptoms Post-traumatic Stress Disorder Checklist: score range 17-85.
COMPLETED
NA
81 participants
Following 12 weeks of therapy.
2020-02-11
Participant Flow
Participant milestones
| Measure |
COPE Therapy
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
Treatment as Usual
Current standard treatment available through the Department of Veteran's Affairs.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
27
|
|
Overall Study
COMPLETED
|
29
|
13
|
|
Overall Study
NOT COMPLETED
|
25
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Integrated Treatment of OEF/OIF Veterans With PTSD & Substance Use Disorders
Baseline characteristics by cohort
| Measure |
Treatment as Usual
n=27 Participants
Relapse Prevention (RP) for substance use disorders.
Included 12 sessions of RP matched for time.
|
COPE Therapy
n=54 Participants
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.9 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
39.7 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
54 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Following 12 weeks of therapy.The hypothesis is that COPE will significantly exceed the treatment as usual control group in reducing Change in Post-traumatic Stress Disorder symptoms as measured by a reduction of 25 points or more in scores for the Clinician Administered Post-traumatic Stress Disorder Scale (CAPS). A lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes. A negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes). Clinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms ≥80: extreme PTSD symptoms Post-traumatic Stress Disorder Checklist: score range 17-85.
Outcome measures
| Measure |
COPE Therapy
n=54 Participants
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
Treatment as Usual
n=27 Participants
CBT for substance use disorder.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
|---|---|---|
|
Change in Post-traumatic Stress Disorder Symptomatology
Clinician Administered PTSD Sore
|
-51.2 score on a scale
Interval -59.7 to -42.8
|
-35.9 score on a scale
Interval -48.8 to -23.0
|
|
Change in Post-traumatic Stress Disorder Symptomatology
The PTSD Checklist for DSM-5 PTSD Diagnosis
|
-22.3 score on a scale
Interval -29.3 to -15.3
|
-10.9 score on a scale
Interval -18.0 to -3.9
|
PRIMARY outcome
Timeframe: Following 12 weeks of therapy.Number of standard drinks reported during drinking day
Outcome measures
| Measure |
COPE Therapy
n=54 Participants
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
Treatment as Usual
n=27 Participants
CBT for substance use disorder.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
|---|---|---|
|
Drinks Per Drinking Day
|
4.6 Number of drinks per drinking day
Standard Deviation 3.6
|
5.0 Number of drinks per drinking day
Standard Deviation 4.1
|
PRIMARY outcome
Timeframe: Following 12 weeks of therapy.Score of PTSD from Clinician Administered PTSD Scale (CAPS) and self-administered PTSD Checklist for DSM-5 PTSD Diagnosis (PCL-5). Lower scores on CAPS and PCL would indicate less severe PTSD. A lower Clinician Administered Post-traumatic Stress Disorder Scale and Post-traumatic Stress Disorder Checklist score would indicate less severe Post-traumatic Stress Disorder/better outcomes. A negative sign in front of a number represents a decrease in score and better/positive outcomes. A greater decrease in a score represents greater improvement in symptoms (more positive outcomes). Clinician Administered Post-traumatic Stress Disorder Scale (CAPS): scores range 0-136 0-19: asymptomatic/few symptoms 20-39: mild PTSD/subthreshold 40-59: moderate PTSD/threshold 60-79: severe PTSD symptoms ≥80: extreme PTSD symptoms Post-traumatic Stress Disorder Checklist: score range 17-85.
Outcome measures
| Measure |
COPE Therapy
n=54 Participants
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
Treatment as Usual
n=27 Participants
CBT for substance use disorder.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
|---|---|---|
|
Post-traumatic Stress Disorder Symptomatology
Clinician Administered PTSD Scale (CAPS)
|
27.2 score on a scale
Standard Deviation 19.4
|
49.7 score on a scale
Standard Deviation 25.3
|
|
Post-traumatic Stress Disorder Symptomatology
PTSD Checklist for DSM-4 PTSD Diagnosis (PCL-5)
|
37.6 score on a scale
Standard Deviation 17.2
|
53.1 score on a scale
Standard Deviation 14.5
|
PRIMARY outcome
Timeframe: After 12 weeks of treatmentClinician Administered PTSD Scale Itemized Scores Within the assessment there are 20 symptoms of PTSD, each with an individual score. A lower score would represent a better outcome (ie less severe symptom). The three itemized symptoms listed below represent hallmark traits/symptoms of PTSD. Overall score range 0-136 Reexperiencing Symptoms range 0-40 Avoidance/Numbing range 0-56 Hyperarousal range 0-40
Outcome measures
| Measure |
COPE Therapy
n=54 Participants
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
Treatment as Usual
n=27 Participants
CBT for substance use disorder.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
|---|---|---|
|
Clinician Administered PTSD Scale Itemized Scores
Clinician Administered PTSD Scale - Hyperarousal
|
11.7 score on a scale
Standard Deviation 8.2
|
19.1 score on a scale
Standard Deviation 6.0
|
|
Clinician Administered PTSD Scale Itemized Scores
Clinician Administered PTSD Scale- Re-experiencing
|
5.6 score on a scale
Standard Deviation 7.1
|
14.6 score on a scale
Standard Deviation 10.7
|
|
Clinician Administered PTSD Scale Itemized Scores
Clinician Admin PTSD Scale - Avoidance/Numbing
|
10.8 score on a scale
Standard Deviation 9.7
|
24 score on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Following 12 weeks of therapy.Population: Reported rate of abstinence
The hypothesis is that COPE will significantly exceed the treatment as usual control group in reducing substance use as measured by decreases in percent days using and increased abstinence rates.
Outcome measures
| Measure |
COPE Therapy
n=27 Participants
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
Treatment as Usual
n=54 Participants
CBT for substance use disorder.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
|---|---|---|
|
Number of Participants Who Report Abstinence
|
7 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Following 12 weeks of therapy.Measure of depression. A lower score would indicate less severe depression. Scores range 0-30
Outcome measures
| Measure |
COPE Therapy
n=54 Participants
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use disorder.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
Treatment as Usual
n=27 Participants
CBT for substance use disorder.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
|---|---|---|
|
Beck Depression Index
|
13 units on a scale (BDI)
Standard Deviation 11
|
19.4 units on a scale (BDI)
Standard Deviation 12.3
|
Adverse Events
COPE Therapy
Treatment as Usual
Serious adverse events
| Measure |
COPE Therapy
n=54 participants at risk
Combined prolonged exposure therapy for PTSD with cognitive behavioral therapy for substance use.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
Treatment as Usual
n=27 participants at risk
Current standard treatment available through the Department of Veteran's Affairs.
Concurrent Treatment with Prolonged Exposure (COPE): 12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
|
|---|---|---|
|
Psychiatric disorders
Attempted suicide
|
0.00%
0/54
|
3.7%
1/27 • Number of events 1
|
|
Psychiatric disorders
hospitalization
|
1.9%
1/54 • Number of events 1
|
0.00%
0/27
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place