Alcohol Drinking, Anxiety Disorders
Conditions
Keywords
Alcohol Abuse, Alcohol Dependence, Alcohol Drinking, Social Anxiety, Social Phobia, Anxiety Disorders
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAnxiety Attention Training
Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.
BEHAVIORALAlcohol Attention Training
Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol.
BEHAVIORALControl Training
Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol.
Sponsors
Miami University
Brown University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current alcohol dependence * Elevated social anxiety symptoms * Willingness to consider cutting down on drinking
Exclusion criteria
* Current psychosis * Unmanaged manic symptoms * Significant cognitive impairment * Other drug use in past month * Receiving cognitive behavioral therapy for alcohol use disorder or social anxiety * Unable to read
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liebowitz Social Anxiety Scale | Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups) | 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). |
| The Daily Drinking Questionnaire | Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 20 |
| 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. | 22 |
| 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. | 20 |
| Total | 86 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Week 1 | Lost to Follow-up | 0 | 0 | 2 | 2 |
| Week 2 | Lost to Follow-up | 3 | 2 | 1 | 3 |
| Week 3 | Lost to Follow-up | 1 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Alcohol Attention Training Only | Anxiety + Alcohol Attention Training | Anxiety Attention Training Only | Control Training | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 21 Participants | 24 Participants | 20 Participants | 84 Participants |
| Age, Continuous | 47.40 years STANDARD_DEVIATION 10.94 | 47.68 years STANDARD_DEVIATION 9.83 | 42.50 years STANDARD_DEVIATION 10.95 | 39.70 years STANDARD_DEVIATION 10.62 | 44.31 years STANDARD_DEVIATION 10.93 |
| Gender Female | 9 Participants | 7 Participants | 9 Participants | 10 Participants | 35 Participants |
| Gender Male | 11 Participants | 15 Participants | 15 Participants | 10 Participants | 51 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 11 Participants | 14 Participants | 10 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 9 Participants | 10 Participants | 6 Participants | 34 Participants |
| Region of Enrollment United States | 20 participants | 22 participants | 24 participants | 20 participants | 86 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 20 | 0 / 22 | 0 / 20 |
| serious Total, serious adverse events | 0 / 24 | 0 / 20 | 0 / 22 | 0 / 20 |
Outcome results
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).
Time frame: Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anxiety Attention Training Only | Liebowitz Social Anxiety Scale | 56.80 units on a scale | Standard Deviation 30.82 |
| Alcohol Attention Training Only | Liebowitz Social Anxiety Scale | 60.94 units on a scale | Standard Deviation 27.7 |
| Anxiety + Alcohol Attention Training | Liebowitz Social Anxiety Scale | 52.05 units on a scale | Standard Deviation 27.23 |
| Control Training | Liebowitz Social Anxiety Scale | 55.05 units on a scale | Standard Deviation 26.08 |
Comparison: 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.p-value: =0.4Mixed Models Analysis
Comparison: 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 alcohol vs. control training.p-value: =0.78Mixed Models Analysis
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.
Time frame: Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anxiety Attention Training Only | The Daily Drinking Questionnaire | 30.25 number of drinks | Standard Deviation 39.49 |
| Alcohol Attention Training Only | The Daily Drinking Questionnaire | 22.82 number of drinks | Standard Deviation 23.03 |
| Anxiety + Alcohol Attention Training | The Daily Drinking Questionnaire | 24.65 number of drinks | Standard Deviation 24.93 |
| Control Training | The Daily Drinking Questionnaire | 18.48 number of drinks | Standard Deviation 24.09 |
Comparison: 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 alcohol vs. control trainingp-value: =0.67Mixed Models Analysis
Comparison: 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 trainingp-value: =0.32Mixed Models Analysis