Trial Outcomes & Findings for Integrated Treatment for Posttraumatic Stress Disorder and Substance Abuse in Young Adults (NCT NCT02667119)
NCT ID: NCT02667119
Last Updated: 2022-09-22
Results Overview
National Stressful Events Posttraumatic Stress Disorder Short Scale. Outcome is presented as a mean item score. Minimum value = 1, Maximum value = 5. Higher scores mean worse outcomes (more severe symptoms).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
Baseline and 3-months post-baseline
Results posted on
2022-09-22
Participant Flow
Participant milestones
| Measure |
Prolonged Exposure + Contingency Management
Standard services plus Prolonged Exposure and Contingency Management
Prolonged Exposure with Contingency Management: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Standard Care
Standard substance abuse treatment services
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Prolonged Exposure + Contingency Management
Standard services plus Prolonged Exposure and Contingency Management
Prolonged Exposure with Contingency Management: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Standard Care
Standard substance abuse treatment services
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
Baseline Characteristics
Integrated Treatment for Posttraumatic Stress Disorder and Substance Abuse in Young Adults
Baseline characteristics by cohort
| Measure |
Prolonged Exposure + Contingency Management
n=14 Participants
Standard services plus Prolonged Exposure and Contingency Management
Prolonged Exposure with Contingency Management: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Standard Care
n=13 Participants
Standard substance abuse treatment services
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.93 years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
22.46 years
STANDARD_DEVIATION 2.11 • n=7 Participants
|
22.70 years
STANDARD_DEVIATION 1.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 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
|
2 Participants
n=7 Participants
|
2 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 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
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
National Stressful Events PTSD Scale
|
3.26 scores on a scale
STANDARD_DEVIATION .58 • n=5 Participants
|
2.82 scores on a scale
STANDARD_DEVIATION .58 • n=7 Participants
|
3.05 scores on a scale
STANDARD_DEVIATION .70 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3-months post-baselinePopulation: Two participants from the Prolonged Exposure + Contingency Management group and one participant from the Standard Care group did not complete assessments at 3 months post-baseline.
National Stressful Events Posttraumatic Stress Disorder Short Scale. Outcome is presented as a mean item score. Minimum value = 1, Maximum value = 5. Higher scores mean worse outcomes (more severe symptoms).
Outcome measures
| Measure |
Prolonged Exposure + Contingency Management
n=12 Participants
Standard services plus Prolonged Exposure and Contingency Management
Prolonged Exposure with Contingency Management: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Standard Care
n=12 Participants
Standard substance abuse treatment services
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
|---|---|---|
|
Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale
|
1.92 score on a scale
Standard Deviation .92
|
2.61 score on a scale
Standard Deviation 1.15
|
PRIMARY outcome
Timeframe: Baseline and 6-month post-baselinePopulation: Three participants from the Prolonged Exposure + Contingency Management group did not complete assessments at 6 months post-baseline.
National Stressful Events Posttraumatic Stress Disorder Short Scale. Outcome is presented as a mean item score. Minimum value = 1, Maximum value = 5. Higher scores mean worse outcomes (more severe symptoms).
Outcome measures
| Measure |
Prolonged Exposure + Contingency Management
n=11 Participants
Standard services plus Prolonged Exposure and Contingency Management
Prolonged Exposure with Contingency Management: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Standard Care
n=13 Participants
Standard substance abuse treatment services
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
|---|---|---|
|
Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale
|
1.64 score on a scale
Standard Deviation .65
|
2.29 score on a scale
Standard Deviation .93
|
PRIMARY outcome
Timeframe: 10 week treatment periodPopulation: Full sample was included
Illicit drug use is assessed twice weekly during the 10 week treatment period. Longest duration of abstinence is calculated as the longest time period in weeks of consecutive negative urine drug screens for illicit drugs during the 10 weeks of treatment.
Outcome measures
| Measure |
Prolonged Exposure + Contingency Management
n=14 Participants
Standard services plus Prolonged Exposure and Contingency Management
Prolonged Exposure with Contingency Management: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Standard Care
n=13 Participants
Standard substance abuse treatment services
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
|---|---|---|
|
Longest Duration of Abstinence From Illicit Drugs (Physiological Measure - Urine Drug Screens)
|
4.29 weeks
Standard Deviation 3.73
|
1.77 weeks
Standard Deviation 2.05
|
SECONDARY outcome
Timeframe: Baseline and 3-month post-baselinePopulation: Two participants from the Prolonged Exposure + Contingency Management group and one participant from the Standard Care group did not complete assessments at 3 months post-baseline.
Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms).
Outcome measures
| Measure |
Prolonged Exposure + Contingency Management
n=12 Participants
Standard services plus Prolonged Exposure and Contingency Management
Prolonged Exposure with Contingency Management: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Standard Care
n=12 Participants
Standard substance abuse treatment services
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
|---|---|---|
|
Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale
|
17.75 score on a scale
Standard Deviation 13.75
|
23.33 score on a scale
Standard Deviation 17.92
|
SECONDARY outcome
Timeframe: Baseline and 6-month post-baselinePopulation: Three participants from the Prolonged Exposure + Contingency Management group did not complete assessments at 6 months post-baseline.
Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms).
Outcome measures
| Measure |
Prolonged Exposure + Contingency Management
n=11 Participants
Standard services plus Prolonged Exposure and Contingency Management
Prolonged Exposure with Contingency Management: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Standard Care
n=13 Participants
Standard substance abuse treatment services
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
|---|---|---|
|
Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale
|
14.64 score on a scale
Standard Deviation 10.70
|
21.69 score on a scale
Standard Deviation 15.14
|
SECONDARY outcome
Timeframe: Baseline and 3-month post-baselinePopulation: Two participants from the Prolonged Exposure + Contingency Management group and one participant from the Standard Care group did not complete assessments at 3 months post-baseline.
Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes.
Outcome measures
| Measure |
Prolonged Exposure + Contingency Management
n=12 Participants
Standard services plus Prolonged Exposure and Contingency Management
Prolonged Exposure with Contingency Management: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Standard Care
n=12 Participants
Standard substance abuse treatment services
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
|---|---|---|
|
Change in Quality of Life as Measured by the Quality of Life Scale
|
1.66 score on a scale
Standard Deviation 1.94
|
1.36 score on a scale
Standard Deviation 2.01
|
SECONDARY outcome
Timeframe: Baseline and 6-month post-baselinePopulation: Three participants from the Prolonged Exposure + Contingency Management group did not complete assessments at 6 months post-baseline.
Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes.
Outcome measures
| Measure |
Prolonged Exposure + Contingency Management
n=11 Participants
Standard services plus Prolonged Exposure and Contingency Management
Prolonged Exposure with Contingency Management: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Standard Care
n=13 Participants
Standard substance abuse treatment services
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
|---|---|---|
|
Change in Quality of Life as Measured by the Quality of Life Scale
|
1.44 score on a scale
Standard Deviation 1.54
|
1.33 score on a scale
Standard Deviation 1.64
|
Adverse Events
Prolonged Exposure + Contingency Management
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Standard Care
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prolonged Exposure + Contingency Management
n=14 participants at risk
Standard services plus Prolonged Exposure and Contingency Management
Prolonged Exposure with Contingency Management: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Standard Care
n=13 participants at risk
Standard substance abuse treatment services
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
|---|---|---|
|
General disorders
Inpatient substance use treatment
|
7.1%
1/14 • Number of events 1 • 6 months
|
23.1%
3/13 • Number of events 3 • 6 months
|
|
Psychiatric disorders
Suicidal ideation (life threatening)
|
0.00%
0/14 • 6 months
|
7.7%
1/13 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Prolonged Exposure + Contingency Management
n=14 participants at risk
Standard services plus Prolonged Exposure and Contingency Management
Prolonged Exposure with Contingency Management: Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided.
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
Standard Care
n=13 participants at risk
Standard substance abuse treatment services
Standard Care: Standard care will consist of treatment as usual in a community-based substance use treatment center.
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation (not life threatening)
|
21.4%
3/14 • Number of events 3 • 6 months
|
23.1%
3/13 • Number of events 4 • 6 months
|
|
General disorders
Emergency room visit
|
14.3%
2/14 • Number of events 2 • 6 months
|
30.8%
4/13 • Number of events 5 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place