Trial Outcomes & Findings for Approach Bias Retraining to Augment Smoking Cessation (NCT NCT03325777)
NCT ID: NCT03325777
Last Updated: 2023-06-09
Results Overview
The primary outcomes were 7-day point-prevalence abstinence (PPA) and prolonged abstinence (PA) at 3-month follow-up (week 18). PPA was defined as self-report of no smoking (not even a puff) during the previous 7 days. Failure to maintain PA at any assessment was defined as smoking on 7 consecutive days or smoking at least once each week over the last 2 consecutive weeks. PPA and PA were assessed by study staff at each appointment using sequential timeline follow-back interviews and biochemically verified by expired carbon monoxide (CO; ≤4 ppm) at each assessment as well as by saliva cotinine (≤10 ng/mL) at weeks 14 and 18. The outcomes in the table below show what percentage of participants remained abstinent at the 3-month follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
18 weeks
Results posted on
2023-06-09
Participant Flow
Participants were recruited via three main channels: 1) fliers and pamphlets in community-based organizations and bulletin boards; 2) social media outlets; and 3) UT Austin resources such as UT Events and digital screen ads.
Of all enrolled participants, 96 met inclusion criteria and were randomized into a condition group.
Participant milestones
| Measure |
Approach Bias Retraining Group
Individuals in this condition will receive seven sessions of ABR training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the training may weaken automatic cigarette-approach and strengthen automatic cigarette-avoidance. Furthermore, they will be told that the opposite effect will be true for the stimuli not related to cigarettes (i.e., the positive stimuli).
Approach Bias Retraining: The Approach Avoidance Task (AAT) used for this experiment is an implicit, computerized paradigm in which participants respond to visually presented pictures on a computer screen displaying either 1) smoking-related images or 2) positive images, by pulling a joystick either towards their body (approach movement) or pushing it away from their body (avoidance movement). By pulling the joystick towards their body, the picture grows in size; by pushing the joystick away, the picture shrinks and then disappears from the screen. Participants are instructed to pull upon seeing an image tilted to the right and to push upon seeing a left-tilt image, while ignoring the image content and responding as quickly and as accurately as possible.
|
Control Group
Individuals in this condition will receive seven sessions of SHAM training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the purpose of the training is to improve control over these automatic tendencies and that following the training sessions, they will easily be able to push or pull the stimuli regardless of content.
SHAM Training: SHAM Training
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
50
|
|
Overall Study
COMPLETED
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
Reasons for withdrawal
| Measure |
Approach Bias Retraining Group
Individuals in this condition will receive seven sessions of ABR training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the training may weaken automatic cigarette-approach and strengthen automatic cigarette-avoidance. Furthermore, they will be told that the opposite effect will be true for the stimuli not related to cigarettes (i.e., the positive stimuli).
Approach Bias Retraining: The Approach Avoidance Task (AAT) used for this experiment is an implicit, computerized paradigm in which participants respond to visually presented pictures on a computer screen displaying either 1) smoking-related images or 2) positive images, by pulling a joystick either towards their body (approach movement) or pushing it away from their body (avoidance movement). By pulling the joystick towards their body, the picture grows in size; by pushing the joystick away, the picture shrinks and then disappears from the screen. Participants are instructed to pull upon seeing an image tilted to the right and to push upon seeing a left-tilt image, while ignoring the image content and responding as quickly and as accurately as possible.
|
Control Group
Individuals in this condition will receive seven sessions of SHAM training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the purpose of the training is to improve control over these automatic tendencies and that following the training sessions, they will easily be able to push or pull the stimuli regardless of content.
SHAM Training: SHAM Training
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
12
|
Baseline Characteristics
Approach Bias Retraining to Augment Smoking Cessation
Baseline characteristics by cohort
| Measure |
Approach Bias Retraining Group
n=46 Participants
Individuals in this condition will receive seven sessions of ABR training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the training may weaken automatic cigarette-approach and strengthen automatic cigarette-avoidance. Furthermore, they will be told that the opposite effect will be true for the stimuli not related to cigarettes (i.e., the positive stimuli).
Approach Bias Retraining: The Approach Avoidance Task (AAT) used for this experiment is an implicit, computerized paradigm in which participants respond to visually presented pictures on a computer screen displaying either 1) smoking-related images or 2) positive images, by pulling a joystick either towards their body (approach movement) or pushing it away from their body (avoidance movement). By pulling the joystick towards their body, the picture grows in size; by pushing the joystick away, the picture shrinks and then disappears from the screen. Participants are instructed to pull upon seeing an image tilted to the right and to push upon seeing a left-tilt image, while ignoring the image content and responding as quickly and as accurately as possible.
|
Control Group
n=50 Participants
Individuals in this condition will receive seven sessions of SHAM training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the purpose of the training is to improve control over these automatic tendencies and that following the training sessions, they will easily be able to push or pull the stimuli regardless of content.
SHAM Training: SHAM Training
|
Total
n=96 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
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
50 participants
n=7 Participants
|
96 participants
n=5 Participants
|
|
Baseline Approach Bias
|
6.4 units on a scale
STANDARD_DEVIATION 239.2 • n=5 Participants
|
139.5 units on a scale
STANDARD_DEVIATION 214.4 • n=7 Participants
|
75.7 units on a scale
STANDARD_DEVIATION 235.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 18 weeksThe primary outcomes were 7-day point-prevalence abstinence (PPA) and prolonged abstinence (PA) at 3-month follow-up (week 18). PPA was defined as self-report of no smoking (not even a puff) during the previous 7 days. Failure to maintain PA at any assessment was defined as smoking on 7 consecutive days or smoking at least once each week over the last 2 consecutive weeks. PPA and PA were assessed by study staff at each appointment using sequential timeline follow-back interviews and biochemically verified by expired carbon monoxide (CO; ≤4 ppm) at each assessment as well as by saliva cotinine (≤10 ng/mL) at weeks 14 and 18. The outcomes in the table below show what percentage of participants remained abstinent at the 3-month follow-up.
Outcome measures
| Measure |
Approach Bias Retraining Group
n=46 Participants
Individuals in this condition will receive seven sessions of ABR training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the training may weaken automatic cigarette-approach and strengthen automatic cigarette-avoidance. Furthermore, they will be told that the opposite effect will be true for the stimuli not related to cigarettes (i.e., the positive stimuli).
Approach Bias Retraining: The Approach Avoidance Task (AAT) used for this experiment is an implicit, computerized paradigm in which participants respond to visually presented pictures on a computer screen displaying either 1) smoking-related images or 2) positive images, by pulling a joystick either towards their body (approach movement) or pushing it away from their body (avoidance movement). By pulling the joystick towards their body, the picture grows in size; by pushing the joystick away, the picture shrinks and then disappears from the screen. Participants are instructed to pull upon seeing an image tilted to the right and to push upon seeing a left-tilt image, while ignoring the image content and responding as quickly and as accurately as possible.
|
Control Group
n=50 Participants
Individuals in this condition will receive seven sessions of SHAM training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the purpose of the training is to improve control over these automatic tendencies and that following the training sessions, they will easily be able to push or pull the stimuli regardless of content.
SHAM Training: SHAM Training
|
|---|---|---|
|
Smoking Status at 3-month Follow Up
|
.57 proportion abstinent
|
.39 proportion abstinent
|
SECONDARY outcome
Timeframe: 18 weeksThe approach-avoidance task (AAT) is an implicit task that measures people's behavioral tendencies to approach or avoid stimuli in the environment. The AAT assessment was used to calculate approach bias tendency at the start of each training session. A positive value indicates a relatively stronger avoidance tendency in response to stimuli. The difference in response latencies is standardized by dividing an individual's difference in reaction time by a personalized standard deviation of the latencies.
Outcome measures
| Measure |
Approach Bias Retraining Group
n=46 Participants
Individuals in this condition will receive seven sessions of ABR training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the training may weaken automatic cigarette-approach and strengthen automatic cigarette-avoidance. Furthermore, they will be told that the opposite effect will be true for the stimuli not related to cigarettes (i.e., the positive stimuli).
Approach Bias Retraining: The Approach Avoidance Task (AAT) used for this experiment is an implicit, computerized paradigm in which participants respond to visually presented pictures on a computer screen displaying either 1) smoking-related images or 2) positive images, by pulling a joystick either towards their body (approach movement) or pushing it away from their body (avoidance movement). By pulling the joystick towards their body, the picture grows in size; by pushing the joystick away, the picture shrinks and then disappears from the screen. Participants are instructed to pull upon seeing an image tilted to the right and to push upon seeing a left-tilt image, while ignoring the image content and responding as quickly and as accurately as possible.
|
Control Group
n=50 Participants
Individuals in this condition will receive seven sessions of SHAM training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the purpose of the training is to improve control over these automatic tendencies and that following the training sessions, they will easily be able to push or pull the stimuli regardless of content.
SHAM Training: SHAM Training
|
|---|---|---|
|
Approach Bias After 7-week Intervention Phase
|
210 units on a scale
Standard Error 26.04
|
39 units on a scale
Standard Error 24.86
|
Adverse Events
Approach Bias Retraining Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Approach Bias Retraining Group
n=46 participants at risk
Individuals in this condition will receive seven sessions of ABR training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the training may weaken automatic cigarette-approach and strengthen automatic cigarette-avoidance. Furthermore, they will be told that the opposite effect will be true for the stimuli not related to cigarettes (i.e., the positive stimuli).
Approach Bias Retraining: The Approach Avoidance Task (AAT) used for this experiment is an implicit, computerized paradigm in which participants respond to visually presented pictures on a computer screen displaying either 1) smoking-related images or 2) positive images, by pulling a joystick either towards their body (approach movement) or pushing it away from their body (avoidance movement). By pulling the joystick towards their body, the picture grows in size; by pushing the joystick away, the picture shrinks and then disappears from the screen. Participants are instructed to pull upon seeing an image tilted to the right and to push upon seeing a left-tilt image, while ignoring the image content and responding as quickly and as accurately as possible.
|
Control Group
n=50 participants at risk
Individuals in this condition will receive seven sessions of SHAM training in which they are instructed to approach (pull the joystick) images tilted to the right and avoid (push the joystick) images tilted to the left. They will be told that the purpose of the training is to improve control over these automatic tendencies and that following the training sessions, they will easily be able to push or pull the stimuli regardless of content.
SHAM Training: SHAM Training
|
|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/46 • 18 weeks
|
2.0%
1/50 • 18 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.00%
0/46 • 18 weeks
|
2.0%
1/50 • 18 weeks
|
|
Vascular disorders
High Blood Pressure
|
0.00%
0/46 • 18 weeks
|
2.0%
1/50 • 18 weeks
|
|
General disorders
Dizziness, Nausea, Physical Discomfort
|
0.00%
0/46 • 18 weeks
|
2.0%
1/50 • 18 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place