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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA034879 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Exposure + Contingency Management | Experimental | Standard services plus Prolonged Exposure and Contingency Management |
|
| Standard Care | Active Comparator | Standard substance abuse treatment services |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Exposure with Contingency Management | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 3-months post-baseline |
| 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). | Baseline and 6-month post-baseline |
| 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. | 10 week treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 3-month post-baseline |
| Change in Severity of Depression Symptoms as Measured by the Center for Epidemiological Studies-Depressed Mood Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristyn Zajac, PhD | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Health | Farmington | Connecticut | 06030 | United States | ||
| The Village for Families and Children - Adult Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26273119 | Background | Zajac K, Sheidow AJ, Davis M. Juvenile Justice, Mental Health, and the Transition to Adulthood: A Review of Service System Involvement and Unmet Needs in the U.S. Child Youth Serv Rev. 2015 Sep 1;56:139-148. doi: 10.1016/j.childyouth.2015.07.014. | |
| 26092742 | Background | Zajac K, Randall J, Swenson CC. Multisystemic Therapy for Externalizing Youth. Child Adolesc Psychiatr Clin N Am. 2015 Jul;24(3):601-16. doi: 10.1016/j.chc.2015.02.007. Epub 2015 Mar 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3-months post-baseline |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient substance use treatment | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation (not life threatening) | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristyn Zajac, PhD | UConn Health | 860-679-8572 | zajac@uchc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2020 | Jun 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard Care | Behavioral | Standard care will consist of treatment as usual in a community-based substance use treatment center. |
|
Center for Epidemiological Studies-Depressed Mood. Minimum value = 0. Maximum value = 60. Higher scores mean worse outcomes (more severe symptoms). |
| Baseline and 6-month post-baseline |
| 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. | Baseline and 3-month post-baseline |
| 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. | Baseline and 6-month post-baseline |
| Hartford |
| Connecticut |
| 06105 |
| United States |
| Farrell Treatment Center | New Britain | Connecticut | 06050 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| National Stressful Events PTSD Scale | Presented as an item mean. Minimum score = 1. Maximum score = 5. Higher equals worse symptoms. | Mean | Standard Deviation | scores on a scale |
|
| OG001 | 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. |
|
|
|
| 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). | Three participants from the Prolonged Exposure + Contingency Management group did not complete assessments at 6 months post-baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6-month post-baseline |
|
|
|
|
| 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. | Full sample was included | Posted | Mean | Standard Deviation | weeks | 10 week treatment period |
|
|
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3-month post-baseline |
|
|
|
|
| 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). | Three participants from the Prolonged Exposure + Contingency Management group did not complete assessments at 6 months post-baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6-month post-baseline |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3-month post-baseline |
|
|
|
|
| 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. | Three participants from the Prolonged Exposure + Contingency Management group did not complete assessments at 6 months post-baseline. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6-month post-baseline |
|
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| 4 |
| 14 |
| EG001 | 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. | 0 | 13 | 4 | 13 | 6 | 13 |
| Suicidal ideation (life threatening) | Psychiatric disorders | Systematic Assessment |
|
| Emergency room visit | General disorders | Systematic Assessment |
|
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