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The purpose of this study is to establish a brief CBT intervention that can largely, if not fully eliminate the deleterious effect of common co-occurring anxiety disorders on alcohol use disorder treatment outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| De-coupling | Experimental | Six sessions of CBT for anxiety-alcohol de-coupling |
|
| Anxiety Reduction | Experimental | Six sessions of CBT for anxiety reduction. |
|
| Combined | Experimental | Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| De-coupling | Behavioral | Six sessions of CBT for anxiety-alcohol de-coupling |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Relapsed to Drinking at 4 Months | Relapse status will be assessed using categorical relapse status (yes vs. no). Count is of those who relapsed | 4 month follow-up |
| Number of Drinking Days in 4 Months Post Treatment | Negative binomial regression with offset for possible drinking days exposure in 4 months post treatment | 4-months |
| Number of Standard Drinks Per Drinking Day | Drinks per drinking day among those who relapsed by 4 months. Standard Drink is defined as 12oz beer, 4ox wine, 3oz fortified wine, 1oz hard liquor | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months | Relapse to Diagnostic and Statistical Manual (DSM)-IV alcohol dependence criteria based on Structured Clinical Interview for DSM-IV (SCID) at 4 months | 4 months |
| Number of Participants Who Relapsed to Hazardous Drinking |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matt Kushner, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lodging Plus Program, Fairview Hospital | Minneapolis | Minnesota | 55454 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | De-coupling | Six sessions of CBT for anxiety-alcohol de-coupling De-coupling: Six sessions of CBT for anxiety-alcohol de-coupling |
| FG001 | Anxiety Reduction | Six sessions of CBT for anxiety reduction. Anxiety Reduction: Six sessions of CBT for anxiety reduction. |
| FG002 | Combined | Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. Combined: Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | De-coupling | Six sessions of CBT for anxiety-alcohol de-coupling De-coupling: Six sessions of CBT for anxiety-alcohol de-coupling |
| BG001 | Anxiety Reduction | Six sessions of CBT for anxiety reduction. Anxiety Reduction: Six sessions of CBT for anxiety reduction. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants That Relapsed to Drinking at 4 Months | Relapse status will be assessed using categorical relapse status (yes vs. no). Count is of those who relapsed | Posted | Count of Participants | Participants | 4 month follow-up |
|
Through 8 month follow-up
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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 | De-coupling | Six sessions of CBT for anxiety-alcohol de-coupling De-coupling: Six sessions of CBT for anxiety-alcohol de-coupling |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matt Kushner, Ph.D. | University of Minnesota | 612-625-7546 | kushn001@umn.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 | Oct 14, 2019 | Feb 17, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 28, 2019 | Jan 6, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Anxiety Reduction |
| Behavioral |
Six sessions of CBT for anxiety reduction. |
|
| Combined | Behavioral | Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. |
|
Relapse to hazardous drinking (hazardous drinking is defined as 3 or more per occasion for women or more than 7 drinks per week, 4 or more per occasion for men or more than 14 drinks per week) at 4 months |
| 4 months |
| BG002 | Combined | Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. Combined: Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. Combined: Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. |
|
|
|
| Primary | Number of Drinking Days in 4 Months Post Treatment | Negative binomial regression with offset for possible drinking days exposure in 4 months post treatment | Posted | Mean | Standard Error | drinking days | 4-months |
|
|
|
|
| Primary | Number of Standard Drinks Per Drinking Day | Drinks per drinking day among those who relapsed by 4 months. Standard Drink is defined as 12oz beer, 4ox wine, 3oz fortified wine, 1oz hard liquor | Posted | Mean | Standard Error | drinks per drinking day | 4 months |
|
|
|
|
| Secondary | Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months | Relapse to Diagnostic and Statistical Manual (DSM)-IV alcohol dependence criteria based on Structured Clinical Interview for DSM-IV (SCID) at 4 months | Posted | Count of Participants | Participants | 4 months |
|
|
|
|
| Secondary | Number of Participants Who Relapsed to Hazardous Drinking | Relapse to hazardous drinking (hazardous drinking is defined as 3 or more per occasion for women or more than 7 drinks per week, 4 or more per occasion for men or more than 14 drinks per week) at 4 months | Posted | Count of Participants | Participants | 4 months |
|
|
|
|
| 0 |
| 92 |
| 0 |
| 92 |
| 0 |
| 92 |
| EG001 | Anxiety Reduction | Six sessions of CBT for anxiety reduction. Anxiety Reduction: Six sessions of CBT for anxiety reduction. | 1 | 94 | 0 | 94 | 0 | 94 |
| EG002 | Combined | Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. Combined: Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. | 1 | 93 | 0 | 93 | 0 | 93 |
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| .562 |
| Wald Chi-squared |
| .101 |
| 2-Sided |
| 95 |
| -.24 |
| .44 |
| Superiority |