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Alcohol contributes to 88,000 deaths and costs an estimated $223 billion annually in the United States. Alcohol use disorder (AUD) is highly prevalent in veterans. The positive public health impact of reducing heavy drinking among veterans with AUD would prevent significant medical morbidity and mortality. Contingency management (CM) is an intensive behavioral therapy that provides incentives to individuals for reducing substance use. Monitoring alcohol abstinence usually requires daily monitoring. Because of this difficulty, CM approaches for treatment of AUD are not currently available to people with AUD. Our group has developed a mobile smart-phone application that allows patients to video themselves using an alcohol breath monitor and transmit the encrypted data to a secure server. This innovation has made the use of CM for outpatient AUD treatment feasible. The aim of the current study is to evaluate the effectiveness and cost effectiveness of CM as an add-on to cognitive behavioral therapy for AUD. The trial will also explore the potential usefulness of a long-term abstinence incentive ontreatment utilization and alcohol outcomes. Proposed is a trial in which 140 veterans with AUD will be randomized to receive either CM as an add-on to evidence-based CBT or CBT alone. Veterans will also be randomized to one of two long-term incentive conditions (i.e., receipt of a monetary incentive for abstinence/low-risk drinking at 6- months vs. no incentive). This project aims to advance AUD treatment by 1) testing the effectiveness of a mobile health approach that makes CM for AUD feasible, and 2) providing highly needed cost-effectiveness data on the use of behavioral incentives as an adjunct to CBT for the treatment of AUD. These aims are designed to address two significant barriers to the implementation of CM for AUD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT + mCM + incentive | Experimental | Participants in this arm will receive 12 sessions of cognitive behavioral treatment, mobile contingency management for alcohol abstinence, and a monetary incentive for 30-day abstinence at the 6-month follow-up. |
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| CBT + mCM + no incentive | Experimental | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and mobile contingency management for alcohol abstinence. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. |
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| CBT alone + incentive | Experimental | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. |
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| CBT alone + no incentive | Active Comparator | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Behavioral | Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Heavy Drinking Days | At the 6-month follow-up visit, participants will self-report the number of heavy drinking (> 5 drinks in day for men, > 4 drinks in a day for women) days they have had in the past thirty days. | 6-month post quit visit |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Heavy Drinking Days | At the 12-month follow-up visit, participants will self-report the number of heavy drinking (> 5 drinks in day for men, > 4 drinks in a day for women) days in the past thirty days. | 12-month post quit visit |
| Average Number of Binge Drinking Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27706 | United States |
There is no plan to share individual participant data.
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Eleven participants were deemed eligible to participate in the study but were not randomized. Seven voluntarily withdrew, and four were lost to contact.
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT + mCM + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment, mobile contingency management for alcohol abstinence, and a monetary incentive for 30-day abstinence at the 6-month follow-up. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Mobile Contingency Management (mCM): Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values. Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | May 16, 2023 |
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| Mobile Contingency Management (mCM) | Behavioral | Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values. |
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| Long-term incentive | Behavioral | This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
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Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days. |
| 6-month post quit visit |
| Average Number of Binge Drinking Days | Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days. | 12-month post quit visit |
| Average Number of Drinking Days | Participants will self-report the number of drinking days in the past thirty days. | 6-month post quit visit |
| Average Number of Drinking Days | Participants will self-report the number of drinking days in the past thirty days. | 12-month post quit visit |
| Average Number of Drinks Per Drinking Day | Participants will self-report the number of drinks on drinking days in the past 30 days. | 6-month post quit visit |
| Average Number of Drinks Per Drinking Day | Participants will self-report the number of drinks on drinking days in the past 30 days. | 12-month post quit visit |
| Number of Participants With Self-reported Abstinence | Participants will self-report whether or not consumed any alcohol in the past 30 days. | 6-month post quit visit |
| Number of Participants With Self-reported Abstinence | Participants will self-report whether or not consumed any alcohol in the past 30 days. | 12-month post quit visit |
| Number of Participants With Bioverification of Low-risk Drinking | Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks. | 6-month post quit visit |
| Number of Participants With Bioverification of Low-risk Drinking | Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks. | 12-month post quit visit |
| Treatment Utilization as Measured by Number of Treatment Visits | Participants will provide self-report on use of adjunct treatments (e.g., Alcoholics Anonymous, group counseling) for alcohol use during the period between post-treatment and follow-ups. Where available, Department of Veterans Affairs administrative data will be used to determine enrollment or involvement in aftercare treatment. | 6-month post quit visit |
| Treatment Utilization as Measured by Number of Treatment Visits | Participants will provide self-report on use of adjunct treatments (e.g., Alcoholics Anonymous, group counseling) for alcohol use during the period between post-treatment and follow-ups. Where available, Department of Veterans Affairs administrative data will be used to determine enrollment or involvement in aftercare treatment. | 12-month post quit visit |
| Health Care Related Quality of Life as Measured by the EuroQol (EQ-5D) | EuroQol (EQ-5D) scoring converts patient-reported health states across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) into a single numerical index (utility value) anchored at 1 (full health) and 0 (dead), with values below 0 possible for states "worse than dead". The EQ-5D utility value typically ranges from ≤ 0 (a state considered "worse than dead") to 1 (perfect health). The study team applied the Pickard et al., 2019 United States value set, which sets the value range from a theoretical minimum of -0.573 to a maximum of 1. This scale is used in health economics to calculate Quality-Adjusted Life-Years (QALYs), where 0 represents being deceased. | 12-month post quit visit |
| CBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed | The number of cognitive behavioral therapy treatment sessions completed by each participant will be measured to determine treatment engagement | Post-treatment, approximately 14 weeks |
| Incremental Cost-Effectiveness Ratio | Measure of cost-effectiveness; computed by dividing the difference in costs between two interventions by the difference in their health outcomes. The formula is (Cost of A - Cost of B) / (Outcome of A - Outcome of B). The result shows the additional cost for each additional unit of health gain from the more effective intervention compared to the less effective one, such as the cost per Quality-Adjusted Life Year (QALY) gained | 12-month post quit visit |
| FG001 | CBT + mCM + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and mobile contingency management for alcohol abstinence. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Mobile Contingency Management (mCM): Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values. |
| FG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| FG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT + mCM + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment, mobile contingency management for alcohol abstinence, and a monetary incentive for 30-day abstinence at the 6-month follow-up. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Mobile Contingency Management (mCM): Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values. Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| BG001 | CBT + mCM + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and mobile contingency management for alcohol abstinence. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Mobile Contingency Management (mCM): Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values. |
| BG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| BG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Average Number of Heavy Drinking Days | At the 6-month follow-up visit, participants will self-report the number of heavy drinking (> 5 drinks in day for men, > 4 drinks in a day for women) days they have had in the past thirty days. | Sixteen participants were excluded from analyses because they were withdrawn or lost to contact prior to the 6-month follow-up visit. | Posted | Mean | Standard Deviation | days | 6-month post quit visit |
|
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| Secondary | Average Number of Heavy Drinking Days | At the 12-month follow-up visit, participants will self-report the number of heavy drinking (> 5 drinks in day for men, > 4 drinks in a day for women) days in the past thirty days. | Thirty-two participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit. | Posted | Mean | Standard Deviation | days | 12-month post quit visit |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Average Number of Binge Drinking Days | Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days. | Sixteen participants were excluded from analyses because they were withdrawn or lost to contact prior to the 6-month follow-up visit. | Posted | Mean | Standard Deviation | days | 6-month post quit visit |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Average Number of Binge Drinking Days | Participants will self-report the number of binge drinking (heavy drinking within a 2-hour period) days in the past thirty days. | Thirty-two participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit. | Posted | Mean | Standard Deviation | days | 12-month post quit visit |
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| Secondary | Average Number of Drinking Days | Participants will self-report the number of drinking days in the past thirty days. | Sixteen participants were excluded from analyses because they were withdrawn or lost to contact prior to the 6-month follow-up visit. | Posted | Mean | Standard Deviation | days | 6-month post quit visit |
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| Secondary | Average Number of Drinking Days | Participants will self-report the number of drinking days in the past thirty days. | Thirty-two participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit. | Posted | Mean | Standard Deviation | days | 12-month post quit visit |
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| Secondary | Average Number of Drinks Per Drinking Day | Participants will self-report the number of drinks on drinking days in the past 30 days. | Sixteen participants were excluded from analyses because they were withdrawn or lost to contact prior to the 6-month follow-up visit. | Posted | Mean | Standard Deviation | drinks | 6-month post quit visit |
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| Secondary | Average Number of Drinks Per Drinking Day | Participants will self-report the number of drinks on drinking days in the past 30 days. | Thirty-two participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit. | Posted | Mean | Standard Deviation | drinks | 12-month post quit visit |
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| Secondary | Number of Participants With Self-reported Abstinence | Participants will self-report whether or not consumed any alcohol in the past 30 days. | Sixteen participants were excluded from analyses because they were withdrawn or lost to contact prior to the 6-month follow-up visit | Posted | Count of Participants | Participants | 6-month post quit visit |
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| Secondary | Number of Participants With Self-reported Abstinence | Participants will self-report whether or not consumed any alcohol in the past 30 days. | Thirty-two participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit. | Posted | Count of Participants | Participants | 12-month post quit visit |
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| Secondary | Number of Participants With Bioverification of Low-risk Drinking | Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks. | Sixteen participants were excluded from analyses because they were withdrawn or lost to contact prior to the 6-month follow-up visit. Additionally, 7 participants failed to send in their PEth test kits for analysis. | Posted | Count of Participants | Participants | 6-month post quit visit |
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| Secondary | Number of Participants With Bioverification of Low-risk Drinking | Participants will provide a fingerstick blood sample. Phosphatidylethanol (PEth) testing will provide any evidence of excessive alcohol use in previous 4 weeks. | Thirty-two participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit. Additionally, 4 participants failed to send in their PEth test kits for analysis. | Posted | Count of Participants | Participants | 12-month post quit visit |
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| Secondary | Treatment Utilization as Measured by Number of Treatment Visits | Participants will provide self-report on use of adjunct treatments (e.g., Alcoholics Anonymous, group counseling) for alcohol use during the period between post-treatment and follow-ups. Where available, Department of Veterans Affairs administrative data will be used to determine enrollment or involvement in aftercare treatment. | 29 participants were withdrawn from analyses due to missing data. | Posted | Mean | Standard Deviation | treatment visits | 6-month post quit visit |
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| Secondary | Treatment Utilization as Measured by Number of Treatment Visits | Participants will provide self-report on use of adjunct treatments (e.g., Alcoholics Anonymous, group counseling) for alcohol use during the period between post-treatment and follow-ups. Where available, Department of Veterans Affairs administrative data will be used to determine enrollment or involvement in aftercare treatment. | 31 participants were withdrawn from analyses due to missing data. | Posted | Mean | Standard Deviation | treatment visits | 12-month post quit visit |
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| Secondary | Health Care Related Quality of Life as Measured by the EuroQol (EQ-5D) | EuroQol (EQ-5D) scoring converts patient-reported health states across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) into a single numerical index (utility value) anchored at 1 (full health) and 0 (dead), with values below 0 possible for states "worse than dead". The EQ-5D utility value typically ranges from ≤ 0 (a state considered "worse than dead") to 1 (perfect health). The study team applied the Pickard et al., 2019 United States value set, which sets the value range from a theoretical minimum of -0.573 to a maximum of 1. This scale is used in health economics to calculate Quality-Adjusted Life-Years (QALYs), where 0 represents being deceased. | Twenty-eight participants were excluded from analyses because they were withdrawn or lost to contact prior to the 12-month follow-up visit. | Posted | Mean | Standard Deviation | units on a scale | 12-month post quit visit |
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| Secondary | CBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed | The number of cognitive behavioral therapy treatment sessions completed by each participant will be measured to determine treatment engagement | Two participants were withdrawn from analyses due to missing data. | Posted | Mean | Standard Deviation | CBT sessions | Post-treatment, approximately 14 weeks |
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| Secondary | Incremental Cost-Effectiveness Ratio | Measure of cost-effectiveness; computed by dividing the difference in costs between two interventions by the difference in their health outcomes. The formula is (Cost of A - Cost of B) / (Outcome of A - Outcome of B). The result shows the additional cost for each additional unit of health gain from the more effective intervention compared to the less effective one, such as the cost per Quality-Adjusted Life Year (QALY) gained | Posted | Mean | Standard Deviation | dollars per QALY gained | 12-month post quit visit |
|
From baseline to one-year follow-up (about one year)
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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 | CBT + mCM + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment, mobile contingency management for alcohol abstinence, and a monetary incentive for 30-day abstinence at the 6-month follow-up. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Mobile Contingency Management (mCM): Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values. Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date | 0 | 35 | 0 | 35 | 2 | 35 |
| EG001 | CBT + mCM + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and mobile contingency management for alcohol abstinence. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Mobile Contingency Management (mCM): Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values. | 0 | 35 | 0 | 35 | 4 | 35 |
| EG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date | 0 | 35 | 0 | 35 | 3 | 35 |
| EG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). | 0 | 35 | 0 | 35 | 1 | 35 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increase in psychological distress | Psychiatric disorders | Non-systematic Assessment | Increase in psychiatric distress due to participating in interviews and completing questionnaires related to symptoms. |
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| headache | Nervous system disorders | Non-systematic Assessment | headache due to alcohol withdrawal |
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| frustration | Psychiatric disorders | Non-systematic Assessment | frustration with technology used in study |
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| irritability | Psychiatric disorders | Non-systematic Assessment | irritability due to alcohol withdrawal |
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| nightmares | Psychiatric disorders | Non-systematic Assessment | nightmares about alcohol use after a period of abstinence |
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| abnormal skin sensations | Skin and subcutaneous tissue disorders | Non-systematic Assessment | abnormal skin sensations due to alcohol withdrawal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Angela Kirby | Duke University School of Medicine | 9198247729 | angela.caison.kirby@gmail.com |
| Dec 14, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2023 | Dec 15, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Female |
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| Unknown, not reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
|
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| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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Participants in this arm will receive 12 sessions of cognitive behavioral treatment and mobile contingency management for alcohol abstinence. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up.
Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).
Mobile Contingency Management (mCM): Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values.
| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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Participants in this arm will receive 12 sessions of cognitive behavioral treatment and mobile contingency management for alcohol abstinence. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up.
Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).
Mobile Contingency Management (mCM): Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values.
| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| OG001 | CBT + mCM + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and mobile contingency management for alcohol abstinence. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Mobile Contingency Management (mCM): Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values. |
| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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| OG002 | CBT Alone + Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). Long-term incentive: This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date |
| OG003 | CBT Alone + no Incentive | Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period. Cognitive Behavioral Therapy (CBT): Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use). |
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