NCT02481752

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 18, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

June 17, 2015

Last Update Submit

August 17, 2016

Conditions

Keywords

Tobacco UseNicotine Dependence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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).

    2 weeks

  • Number of Days Abstinent as assessed by daily cigarette count during a self-guided quit attempt.

    2 weeks

  • Self Efficacy as assessed by the Relapse Situation Self-Efficacy questionnaire.

    2 weeks

  • Urge to Smoke as assessed by the QSU-brief (Questionnaire of Smoking Urges).

    2 weeks

Study Arms (2)

AAT Training Group

EXPERIMENTAL

Individuals in this condition will receive four sessions of AAT 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).

Other: Approach Avoidance Training

SHAM Training Group

SHAM COMPARATOR

Individuals in this condition will receive four 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.

Other: SHAM Training

Interventions

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.

AAT Training Group
SHAM Training Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Tobacco UseTobacco Use Disorder

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jasper A Smits, Ph.D.

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR
  • Scarlett O Baird, B.A.

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 25, 2015

Study Start

July 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 18, 2016

Record last verified: 2016-08

Locations