Approach Bias Retraining to Augment Smoking Cessation



Status:Recruiting
Conditions:Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:5/5/2018
Start Date:November 29, 2017
End Date:June 1, 2020
Contact:Haley E Conroy, B.A.
Email:haleyeconroy@utexas.edu
Phone:512- 471- 5935

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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.

The integrated intervention involves seven weekly 60-minute sessions. Each session involves
15 minutes of computerized approach bias retraining followed by 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 session, the study therapist will begin by 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. 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 5.
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 sessions 2-4, participants will begin by completing the computerized task. 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).

Session 5, the day of the quit attempt, will begin with the ABR task. 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 5, 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 6 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 8, 1- month (week
9), 2-month (week 13), and 3-month (week 17). The primary function of these visits is to
gather information about the participants smoking habits post treatment.

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 1 year

- Currently smoke an average of at least 5 cigarettes per day

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

Exclusion Criteria:

- A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional
disorders; an eating disorder in the past 6 months; organic brain syndrome, mental
retardation or other cognitive dysfunction that could interfere with capacity to
engage in therapy; a history of substance or alcohol abuse or dependence (other than
nicotine) in the last 6 months or otherwise unable to commit to refraining from
alcohol use during the acute period of study participation.

- Visual or hand-motoric impairments

- Current use of nicotine replacement therapy

- Current use of any other pharmacotherapy or psychotherapy for smoking cessation not
provided by the researchers during the quit attempt

- Current use of tobacco products other than cigarettes

- Insufficient command of the English language as the treatment manual is written only
in English and study staff are not fluent in other languages
We found this trial at
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Austin, Texas 78712
Phone: 512-471-5935
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