The Effect of AAT Training in Smokers

Tobacco Use Clinical Trial

Official title:

The Effect of AAT Training in Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481752
• Other study ID #: 2015-02-0023
• Status: Completed
• Phase: N/A
• First received: June 17, 2015
• Last updated: August 17, 2016
• Start date: July 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to investigate the effect of a brief computer task (Approach Avoidance Task) on smoking cessation. The investigators will use a novel training protocol that works to target automatic thoughts and tendencies that occur outside of conscious control. Previous research suggests that these automatic tendencies may have a direct effect on certain health behaviors- like continuing to smoke despite having previous quit attempts.

The investigators hypothesize that individuals in the AAT training condition will evidence a greater decrease in reaction times to avoid smoking-related stimuli & approach positive stimuli relative to those in the control condition. The investigators also expect that individuals in the AAT condition will exhibit superior outcomes on several quit-related variables as evidenced by an increase in motivation to quit smoking, an increase in number of days abstinent following a self-guided quit attempt, an increase in self-efficacy, and a decrease in urge to smoke compared to those in the SHAM training condition.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female patients ages 18-65 capable of providing informed consent

• Willing and able to provide informed consent, attend all study visits, and comply with the protocol

• Daily smoker for at least 6 months

• Currently smoke an average of at least 8 cigarettes per day

• Report a motivation to quit smoking of at least 5 on a 10-point scale

• Interest in making a serious quit attempt within the next month (without professional assistance or nicotine therapy)

• Have not decreased their number of cigarettes by more than half in the last six months

Exclusion Criteria:

• Visual or hand-motoric impairments

• Current use of nicotine replacement therapy

• Current use of tobacco products other than cigarettes

• Insufficient command of the English language

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Other:
• Approach Avoidance Training
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.
• SHAM Training

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction Time on Approach Avoidance Task	The time between the start of the trial and the picture disappearing from the screen will be recorded. The investigators will look at the change in response times for each individual. The investigators hypothesize that there will be a greater decrease in reaction time for those in the AAT training group.	2 weeks	No
Secondary	Motivation to Quit Smoking as assessed by having participants rate their motivation to quit smoking on a scale of 1 to 10 (1 being not motivated at all and 10 being extremely motivated to quit).	The investigators expect that individuals in the AAT training condition will have a greater motivation to quit smoking relative to those in the SHAM condition.	2 weeks	No
Secondary	Number of Days Abstinent as assessed by daily cigarette count during a self-guided quit attempt.	The investigators hypothesize that individuals in the AAT training condition will be more likely to have a greater number of days abstinent following Quit Day relative to those in the SHAM condition.	2 weeks	No
Secondary	Self Efficacy as assessed by the Relapse Situation Self-Efficacy questionnaire.	The investigators expect to see a greater increase in self-efficacy for the AAT training group relative to the SHAM training group.	2 weeks	No
Secondary	Urge to Smoke as assessed by the QSU-brief (Questionnaire of Smoking Urges).	The investigators hypothesize that individuals in the AAT training condition will evidence a greater decrease in urge to smoke relative to those in the SHAM condition.	2 weeks	No