Approach Bias Retraining to Augment Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      Tobacco use is the most preventable cause of disease, disability, and death in the United
      States. Standard smoking cessation care (cognitive behavioral therapy and nicotine
      replacement therapy), is effective in approximately 20% of the cases, clearly indicating
      there is substantial room for improvement.

      Current work suggests that despite standard interventions, continued substance abuse may
      result from addictive behaviors governed partly through automatic processes that exert their
      influence outside conscious control. This is important from a treatment perspective, as we
      should develop treatments to target implicit processes.

      Among a number of promising targets for intervention, cognitive biases are important to
      address as they have been implicated as maintenance factors for addiction. Approach bias,
      defined as the automatically activated action tendency to approach smoking-related stimuli,
      is a relatively novel cognitive bias and has been related to failed smoking cessation. A
      recently developed task for approach bias assessment is the Approach Bias Retraining (ABR), a
      computerized joystick task increasingly used to measure automatic approach tendencies in
      addiction research.

      This clinical trial will evaluate a smoking cessation intervention that integrates standard
      care with approach bias retraining. Results will provide novel information regarding the
      potential benefits of engaging implicit cognitive biases as a means to augment traditional
      smoking cessation therapy. This study has the potential to help individuals attempting to
      quit smoking and, ultimately, provide unique information about the importance of targeting
      implicit processes to complement standard care.
    

Detailed description: 
      The integrated intervention involves seven weekly 60-minute therapy sessions. The each
      therapy session involves 15 minutes of computerized approach bias retraining and 45 minutes
      of individual cognitive behavioral therapy. In order to maximize adherence, the scheduling of
      session visits will be individualized to each participant's schedule.

      During the first therapy session, the study therapist will collect relevant smoking
      assessments and begin orienting the participant to the joystick procedures. The therapist
      will explain that the joystick task is thought to affect your automatic tendencies to
      approach or avoid cigarettes. At this time the participant will complete the first session of
      approach bias retraining.

      Participants will begin therapy sessions 2-6 by completing the computerized approach bias
      retraining task. At session 2, the therapist will then congratulate participants for deciding
      to quit smoking, review the positive health consequences of quitting, and express their
      willingness to help the participant succeed. Participants' past quit attempts will be
      reviewed to identify what strategies contributed to success and what factors hindered their
      previous attempts and a target quit date will be set for week 6. Lastly, participants will
      initiate self-monitoring or track each cigarette they smoke through Quit date and note
      situational cues for smoking (e.g. times of the day, activities while smoking).

      During therapy sessions 2-5, the therapists will then assist participants in anticipating
      situations in their lives that will likely place them at risk for relapse, prepare them for
      the possibility of lapsing, and provide strategies for coping with the potential negative
      emotional reactions to lapsing. In addition, therapists will advise all participants to avoid
      or reduce drinking and advise all participants to tell their friends and family about their
      quit date and will discuss ways to increase social support during the quit attempt. Lastly,
      therapists will instruct participants in the proper use of the nicotine patch (e.g.,
      placement of patch, use one a day, importance of not smoking while using the patch) and help
      them prepare for the quit day (e.g., removing all tobacco products from their environment).

      At session 6, participants will initiate a quit attempt. Therapists will provide individual
      support for participants during this early period of abstinence. This contact will provide
      the opportunity for more tailored and elaborate discussions of quitting experiences and
      coping strategies for anticipated high-risk situations. Therapists will also reinforce
      success and provide support and encouragement for participants who slip and smoke and ask
      participants to anticipate potential challenges to remaining abstinent from smoking and
      discuss strategies for coping with those situations. In addition, during this session,
      therapists will ask participants to discuss social supports for nonsmoking, help to develop
      strategies for maximizing social support systems and develop participants' skills in
      requesting behavioral changes from others. Beginning week 6, participants will be instructed
      to apply one patch daily. Participants will use the full strength 21-mg patch for 6 weeks and
      then be instructed to taper to the 14-mg patch for the next 1 week, and then to the 7-mg
      patch for the remaining 1 week.

      Session 7 will be the last day that the ABR task is administered. This session will focus
      primarily on relapse prevention. Therapists will continue with relapse prevention tactics,
      including provision of social support, avoiding high-risk situations, using social support
      from friends/co-workers, and maintaining non-smoking lifestyle changes.

      Participants will be asked to come in for a brief follow-up visit at week 9, 1- month (week
      10), 2-month (week 14), and 3-month (week 18). The primary function of these visits is to
      gather information about the participants smoking habits post treatment.
    

Intervention name(s): Approach Bias Retraining; SHAM Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cigarettes; Tobacco Use