Trial Outcomes & Findings for Retraining Attention to Treat Alcohol Dependence and Social Anxiety (NCT NCT01886716)
NCT ID: NCT01886716
Last Updated: 2016-12-28
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
Baseline, weekly throughout the 4-week trial, and in the follow-up sessions (1 week and 1 month follow-ups)
Results posted on
2016-12-28
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Week 1
STARTED
|
24
|
20
|
22
|
20
|
|
Week 1
COMPLETED
|
24
|
20
|
20
|
18
|
|
Week 1
NOT COMPLETED
|
0
|
0
|
2
|
2
|
|
Week 2
STARTED
|
24
|
20
|
20
|
18
|
|
Week 2
COMPLETED
|
21
|
18
|
19
|
15
|
|
Week 2
NOT COMPLETED
|
3
|
2
|
1
|
3
|
|
Week 3
STARTED
|
21
|
18
|
19
|
15
|
|
Week 3
COMPLETED
|
20
|
17
|
19
|
14
|
|
Week 3
NOT COMPLETED
|
1
|
1
|
0
|
1
|
|
Week 4
STARTED
|
20
|
17
|
19
|
14
|
|
Week 4
COMPLETED
|
20
|
17
|
19
|
14
|
|
Week 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
1-Week Post Follow-Up
STARTED
|
20
|
17
|
19
|
14
|
|
1-Week Post Follow-Up
COMPLETED
|
20
|
17
|
19
|
14
|
|
1-Week Post Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
1-Month Post Follow-Up
STARTED
|
20
|
17
|
19
|
14
|
|
1-Month Post Follow-Up
COMPLETED
|
20
|
17
|
19
|
14
|
|
1-Month Post Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
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
Retraining Attention to Treat Alcohol Dependence and Social Anxiety
Baseline characteristics by cohort
| Measure |
Anxiety Attention Training Only
n=24 Participants
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.
|
Alcohol Attention Training Only
n=20 Participants
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.
|
Anxiety + Alcohol Attention Training
n=22 Participants
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.
|
Control Training
n=20 Participants
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.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Continuous
|
42.50 years
STANDARD_DEVIATION 10.95 • n=5 Participants
|
47.40 years
STANDARD_DEVIATION 10.94 • n=7 Participants
|
47.68 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
39.70 years
STANDARD_DEVIATION 10.62 • n=4 Participants
|
44.31 years
STANDARD_DEVIATION 10.93 • n=21 Participants
|
|
Gender
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Gender
Male
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
20 participants
n=7 Participants
|
22 participants
n=5 Participants
|
20 participants
n=4 Participants
|
86 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Anxiety Attention Training Only
n=20 Participants
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.
|
Alcohol Attention Training Only
n=17 Participants
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.
|
Anxiety + Alcohol Attention Training
n=19 Participants
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.
|
Control Training
n=14 Participants
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.
|
|---|---|---|---|---|
|
Liebowitz Social Anxiety Scale
|
56.80 units on a scale
Standard Deviation 30.82
|
60.94 units on a scale
Standard Deviation 27.70
|
52.05 units on a scale
Standard Deviation 27.23
|
55.05 units on a scale
Standard Deviation 26.08
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Anxiety Attention Training Only
n=20 Participants
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.
|
Alcohol Attention Training Only
n=17 Participants
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.
|
Anxiety + Alcohol Attention Training
n=19 Participants
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.
|
Control Training
n=14 Participants
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.
|
|---|---|---|---|---|
|
The Daily Drinking Questionnaire
|
30.25 number of drinks
Standard Deviation 39.49
|
22.82 number of drinks
Standard Deviation 23.03
|
24.65 number of drinks
Standard Deviation 24.93
|
18.48 number of drinks
Standard Deviation 24.09
|
Adverse Events
Anxiety Attention Training Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcohol Attention Training Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Anxiety + Alcohol Attention Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place