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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AA021151 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Miami University | OTHER |
| Brown University | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this research is to test a computerized intervention for people with co-occurring social anxiety and alcohol dependence. The intervention seeks to reduce symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues. The investigators expect that participants receiving alcohol or anxiety training will experience reductions in those specific symptoms compared to participants in a control condition. The investigators also expect that participants receiving combined alcohol and anxiety training will show the largest reductions in alcohol and anxiety symptoms, relative to participants in any other condition.
Alcohol Use Disorders (AUDs) and Social Anxiety Disorder are disabling and chronic conditions. In spite of these common and significantly overlapping problems, insight into the mechanisms linking alcohol dependence and social anxiety symptoms is minimal, and there are not well established treatment guidelines for this population. In this study, the investigators seek to develop a computerized intervention for individuals with symptoms of social anxiety and alcohol dependence. The intervention attempts to reduce symptoms by shifting attention away from alcohol-relevant and/or socially threatening cues. The investigators expect that participants receiving alcohol or anxiety training will experience reductions in those specific symptoms compared to participants in a control condition. The investigators also expect that participants receiving combined alcohol and anxiety training will show the largest reductions in alcohol and anxiety symptoms, relative to participants in any other condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anxiety Attention Training only | Experimental | Participants will receive Anxiety Attention Training and placebo Alcohol training. |
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| Alcohol Attention Training only | Experimental | Participants will receive Alcohol Attention Training and placebo Anxiety training. |
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| Anxiety + Alcohol Attention Training | Experimental | Participants will receive both Anxiety Attention Training and Alcohol Attention Training. |
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| Control Training | Placebo Comparator | Participants will receive placebo Anxiety Training and placebo Alcohol training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anxiety Attention Training | Behavioral | Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety. |
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| Measure | Description | Time Frame |
|---|---|---|
| Liebowitz Social Anxiety Scale | The experimenter-administered Liebowitz Social Anxiety Scale (Liebowitz, 1987) was the primary measure to assess social anxiety symptoms. This well-validated instrument assesses fear and avoidance across a range of 24 social and performance situations during the course of the previous week. A total LSAS score was computed, ranging from 0 (no fear or avoidance) to 144 (the greatest level of fear and avoidance). | Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups) |
| The Daily Drinking Questionnaire | The Daily Drinking Questionnaire (Collins, Parks, & Marlatt, 1985) was the primary measure used to assess weekly alcohol consumption. This calendar-based measure was administered by the experimenter once per week to monitor changes in symptoms. The measure assessed the total number of drinks in the past week. | Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua C Magee, Ph.D. | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Department of Family and Community Medicine | Cincinnati | Ohio | 45206 | United States |
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Random assignment occurred during Week 1, the next visit after the baseline orientation session. Out of 115 participants completing the baseline session, 21 dropped out prior to random assignment. To ensure current symptoms, another 8 were excluded due to baseline reports of no or extremely low alcohol consumption and/or social anxiety, leaving 86.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anxiety Attention Training Only | Participants will receive Anxiety Attention Training and placebo Alcohol training. Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety. |
| FG001 | Alcohol Attention Training Only | Participants will receive Alcohol Attention Training and placebo Anxiety training. Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol. |
| FG002 | Anxiety + Alcohol Attention Training | Participants will receive both Anxiety Attention Training and Alcohol Attention Training. Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety. Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol. |
| FG003 | Control Training | Participants will receive placebo Anxiety Training and placebo Alcohol training. Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Week 1 |
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| Week 2 |
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| Week 3 |
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| Week 4 |
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| 1-Week Post Follow-Up |
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| 1-Month Post Follow-Up |
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Participants who remained in the study through the initial Week 1 session in which random assignment occurred, as well as who reported current symptoms on alcohol consumption and social anxiety measures at the baseline orientation session (see Pre-Assignment Details and Participant Flow).
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| ID | Title | Description |
|---|---|---|
| BG000 | Anxiety Attention Training Only | Participants will receive Anxiety Attention Training and placebo Alcohol training. Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety. |
| BG001 | Alcohol Attention Training Only |
| 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, Categorical | Count of Participants |
| 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 | Liebowitz Social Anxiety Scale | The experimenter-administered Liebowitz Social Anxiety Scale (Liebowitz, 1987) was the primary measure to assess social anxiety symptoms. This well-validated instrument assesses fear and avoidance across a range of 24 social and performance situations during the course of the previous week. A total LSAS score was computed, ranging from 0 (no fear or avoidance) to 144 (the greatest level of fear and avoidance). | Posted | Mean | Standard Deviation | units on a scale | Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups) |
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Monitoring for adverse events occurred at baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups).
Research assistants completed check-ins for concerns. Two measures were also monitored for significant negative changes,the LSAS and AWSC. Participants scoring ≥9 points above their baseline LSAS score or ≥23 on the AWSC were evaluated by the site principal investigator for the possibility of clinical deterioration and/or symptoms requiring emergency intervention (e.g., suicidal ideation with intent).
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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 | Anxiety Attention Training Only | Participants will receive Anxiety Attention Training and placebo Alcohol training. Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elise Clerkin | Miami University | 513-529-2483 | clerkiem@miamioh.edu |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D001008 | Anxiety Disorders |
| D000437 | Alcoholism |
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Alcohol Attention Training | Behavioral | Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol. |
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| Control Training | Behavioral | Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol. |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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Participants will receive Alcohol Attention Training and placebo Anxiety training. Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol. |
| BG002 | Anxiety + Alcohol Attention Training | Participants will receive both Anxiety Attention Training and Alcohol Attention Training. Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety. Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol. |
| BG003 | Control Training | Participants will receive placebo Anxiety Training and placebo Alcohol training. Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 |
| Alcohol Attention Training Only |
Participants will receive Alcohol Attention Training and placebo Anxiety training. Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol. |
| OG002 | Anxiety + Alcohol Attention Training | Participants will receive both Anxiety Attention Training and Alcohol Attention Training. Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety. Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol. |
| OG003 | Control Training | Participants will receive placebo Anxiety Training and placebo Alcohol training. Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol. |
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| Primary | The Daily Drinking Questionnaire | The Daily Drinking Questionnaire (Collins, Parks, & Marlatt, 1985) was the primary measure used to assess weekly alcohol consumption. This calendar-based measure was administered by the experimenter once per week to monitor changes in symptoms. The measure assessed the total number of drinks in the past week. | Posted | Mean | Standard Deviation | number of drinks | Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups) |
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| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Alcohol Attention Training Only | Participants will receive Alcohol Attention Training and placebo Anxiety training. Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol. | 0 | 20 | 0 | 20 |
| EG002 | Anxiety + Alcohol Attention Training | Participants will receive both Anxiety Attention Training and Alcohol Attention Training. Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety. Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol. | 0 | 22 | 0 | 22 |
| EG003 | Control Training | Participants will receive placebo Anxiety Training and placebo Alcohol training. Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol. | 0 | 20 | 0 | 20 |
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| D019966 |
| Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D010698 | Phobic Disorders |
| The analyses used multilevel modeling to capture both the trajectories of symptoms within individuals (i.e., level 1) and the hypothesized between-subject moderators of these trajectories, alcohol and anxiety attention training (i.e., level 2) across all 7 time points. Note, although all 4 groups are included in this analysis, this analysis specifically compares anxiety vs. control training | Mixed Models Analysis | =.32 | Slope | .07 | Standard Error of the Mean | .07 | 2-Sided | F(1,517) = 1.01 | No | Superiority or Other |