Posttraumatic Stress Disorder, Substance Use Disorder
Conditions
Brief summary
The purpose of the study is to determine the safety and efficacy of an integrated treatment for substance abuse and posttraumatic stress disorder for young adults. The integrated treatment includes two established psychosocial treatments for substance abuse (Contingency Management) and posttraumatic stress disorder (Prolonged Exposure therapy).
Interventions
BEHAVIORALProlonged 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.
BEHAVIORALStandard Care
Standard care will consist of treatment as usual in a community-based substance use treatment center.
Sponsors
National Institute on Drug Abuse (NIDA)
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* 18-25 years old * meets diagnostic criteria for substance use disorder * meets diagnostic criteria for full or subthreshold posttraumatic stress disorder * currently able to provide a urine drug screen that is negative for cocaine, prescription opiates, and non-prescribed methadone or provided this type of screen in the past 60 days * speaks English
Exclusion criteria
* significant cognitive impairment or serious uncontrolled psychiatric problem (other than posttraumatic stress disorder) * in recovery from pathological gambling or current pathological gambling diagnosis * in a current domestic violence relationship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale | Baseline and 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). |
| Longest Duration of Abstinence From Illicit Drugs (Physiological Measure - Urine Drug Screens) | 10 week treatment period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale | Baseline and 3-month post-baseline | Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms). |
| Change in Quality of Life as Measured by the Quality of Life Scale | Baseline and 3-month post-baseline | Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 13 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
Baseline characteristics
| Characteristic | Prolonged Exposure + Contingency Management | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 22.93 years STANDARD_DEVIATION 1.89 | 22.46 years STANDARD_DEVIATION 2.11 | 22.70 years STANDARD_DEVIATION 1.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 9 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| National Stressful Events PTSD Scale | 3.26 scores on a scale STANDARD_DEVIATION 0.58 | 2.82 scores on a scale STANDARD_DEVIATION 0.58 | 3.05 scores on a scale STANDARD_DEVIATION 0.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 6 Participants | 19 Participants |
| Region of Enrollment United States | 14 participants | 13 participants | 27 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 4 / 14 | 6 / 13 |
| serious Total, serious adverse events | 1 / 14 | 4 / 13 |
Outcome results
Primary
Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale
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).
Time frame: Baseline and 3-months post-baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure + Contingency Management | 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 0.92 |
| Standard Care | Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale | 2.61 score on a scale | Standard Deviation 1.15 |
Comparison: Compared the two groups at 3 months post-baselinep-value: 0.041ANCOVA
Primary
Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale
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).
Time frame: Baseline and 6-month post-baseline
Population: Three participants from the Prolonged Exposure + Contingency Management group did not complete assessments at 6 months post-baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure + Contingency Management | 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 0.65 |
| Standard Care | Change in Severity of Posttraumatic Stress Disorder Symptoms as Measured by the National Stressful Events PTSD Scale | 2.29 score on a scale | Standard Deviation 0.93 |
p-value: 0.016ANCOVA
Primary
Longest Duration of Abstinence From Illicit Drugs (Physiological Measure - Urine Drug Screens)
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.
Time frame: 10 week treatment period
Population: Full sample was included
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure + Contingency Management | Longest Duration of Abstinence From Illicit Drugs (Physiological Measure - Urine Drug Screens) | 4.29 weeks | Standard Deviation 3.73 |
| Standard Care | Longest Duration of Abstinence From Illicit Drugs (Physiological Measure - Urine Drug Screens) | 1.77 weeks | Standard Deviation 2.05 |
p-value: 0.04t-test, 2 sided
Secondary
Change in Quality of Life as Measured by the Quality of Life Scale
Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes.
Time frame: Baseline and 3-month post-baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure + Contingency Management | Change in Quality of Life as Measured by the Quality of Life Scale | 1.66 score on a scale | Standard Deviation 1.94 |
| Standard Care | Change in Quality of Life as Measured by the Quality of Life Scale | 1.36 score on a scale | Standard Deviation 2.01 |
p-value: 0.25ANCOVA
Secondary
Change in Quality of Life as Measured by the Quality of Life Scale
Quality of Life Scale. Minimum value = -6. Maximum value = +6. Score is an item mean. Higher scores mean better outcomes.
Time frame: Baseline and 6-month post-baseline
Population: Three participants from the Prolonged Exposure + Contingency Management group did not complete assessments at 6 months post-baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure + Contingency Management | Change in Quality of Life as Measured by the Quality of Life Scale | 1.44 score on a scale | Standard Deviation 1.54 |
| Standard Care | Change in Quality of Life as Measured by the Quality of Life Scale | 1.33 score on a scale | Standard Deviation 1.64 |
p-value: 0.508ANCOVA
Secondary
Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale
Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms).
Time frame: Baseline and 3-month post-baseline
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure + Contingency Management | 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 |
| Standard Care | Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale | 23.33 score on a scale | Standard Deviation 17.92 |
p-value: 0.148ANCOVA
Secondary
Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale
Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms).
Time frame: Baseline and 6-month post-baseline
Population: Three participants from the Prolonged Exposure + Contingency Management group did not complete assessments at 6 months post-baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure + Contingency Management | 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 10.7 |
| Standard Care | Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale | 21.69 score on a scale | Standard Deviation 15.14 |
p-value: 0.043ANCOVA