Cognitive and Emotional Skills to Aid Smoking Cessation



Status:Not yet recruiting
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:6/15/2018
Start Date:October 2018
End Date:September 2020
Contact:Michael W. Otto, PhD
Email:mwotto@bu.edu
Phone:617-306-1836

Use our guide to learn which trials are right for you!

Cigarette smoking is a leading cause of morbidity and mortality in the United States. Among
individuals who engage in smoking cessation treatment, attrition rates remain high. Many
smokers experience difficulties in regulating their emotions, which reduces their ability to
benefit from standard interventions and leads to increased smoking behaviors. In addition,
cognitive deficits (e.g., reduced working memory capacity) may prevent smokers from applying
information from interventions, making smart choices about the benefits and risks of smoking,
and resisting smoking advertisements.

This study will test whether adding a working memory training and motivational enhancement
component to a standard, evidence-based cognitive behavioral therapy-based smoking cessation
program (SCP) can improve treatment adherence and successful quit rates. This study will
compare 5 sessions of SCP with an additional wellness-focused component (control
intervention) to SCP incorporating motivational enhancement and working memory training
("enhanced" intervention). Participants will be adult smokers recruited from the greater
Boston community who are interested in quitting smoking. This study will determine the
efficacy, acceptability, and feasibility of the enhanced intervention.

This study is targeting adult smokers in the greater Boston community who are interested in
entering smoking cessation treatment. This study will employ a block randomization of 74
smoking participants to one of two intervention conditions: (1) a control condition offering
the 5-session standard, smoking cessation program (SCP) plus a wellness component, (2) a
treatment condition offering the 5-session SCP, a motivational enhancement component, and
working memory training.

Research assessments will consist of participant self-reports of smoking behavior and
proximal smoking measures (e.g., cravings) as well as self-report of personality
characteristics (e.g., sensation seeking) associated with risk behaviors. CO exhalations will
also be evaluated to confirm non-smoking status. Subjects will wear a wrist worn wearable
sensor to monitor their physiological data and physical activity. The sensors will measure
heart rate, inter-beat interval, electrodermal activity, skin temperature and acceleration
signal arising from body movement. Once the data is collected, it will be statistically
analyzed and machine learning techniques used to determine if specific physiological and
behavioral markers precede smoking behavior (ex fidgeting). In addition, each participant's
intervention session attendance and engagement will be recorded by the therapist.
Participants in both conditions will make their quit attempt prior to the 5th and final
intervention session, and will be invited to return for a follow-up visit at 1 week, 2 weeks,
and 1 month after completing the final session, at which time their smoking status and
related outcomes will be re-assessed.

Participants who miss more than 50% of intervention sessions will be considered off-protocol,
but will remain in the study.

Participants will be randomly assigned to 1 of 2 study conditions. Each intervention is to be
delivered over five consecutive weeks. Interventions will be led by Master's- or
Doctoral-level study clinicians with ongoing supervision from Dr. Otto. For the working
memory training component of the enhanced treatment condition, a computerized training
program will be utilized.

All interventions will be delivered in groups with variable group size (1-8 members). Each of
the study interventions is to be delivered once per week over five consecutive weeks. Therapy
components of the sessions will be 60 minutes in length. Sessions may last, in total, up to
2.5 hours. Between intervention sessions, participants will also be asked to complete
homework to practice skills learned during each session.

The first half of each intervention session (across randomized conditions) will consist of
material adapted from the Smoking Cessation Program (SCP)—a standard, manualized cognitive
behavioral therapy-based intervention for individuals interested in quitting smoking. The
program, administered by a trained interventionist, combines empirically validated smoking
and relapse prevention techniques. Specific goals of the sessions include targeting barriers
to smoking cessation, enhancing self-confidence/preparedness for quitting smoking, and
positive lifestyle changes.

Enhanced Intervention Condition

During the second half of each intervention session, participants in the Enhanced
Intervention condition will complete 45 minutes of computerized working memory training,
adapted from the Cogmed QM program. Participants in this condition will also be asked to use
the program a few times a week for 25-35 minutes between sessions,remotely on a home computer
or at a computer provided at the BU Translational Research Program lab (to ensure all
participants have adequate access to the program). The CogMed QM program has been shown to
produce higher effect sizes than other programs including noncommercial programs developed by
researchers for the purposes of their studies. It resembles a video game, and comprises
several different "games" that require visuo-spatial working memory (remembering the position
of objects) and a combination of verbal and visual working memory (remembering phonemes,
letters, and digits). The program adapts to the user's performance. If the trainee is doing
well, the to-be-remembered list will increase by one item. If the trainee is struggling, the
to-be-remembered list will decrease by one item. Accordingly, trainees are able to perform at
the limit of their ability, stimulating WM capacity adaptation.

Before and after completing their weekly CogMed QM working memory training task, participants
will be asked to reflect on their long-term goals for quitting smoking, using guided imagery
about future smoking/non-smoking life status as well as open-ended exploration of the
perceived advantages and disadvantages of smoking versus quitting. Participants will be
informed of the hypothesized role of working memory training as an exercise to help them keep
their long-term goals in mind when cravings and temptations arise, and will be encouraged to
use the skills they are practicing during the working memory exercise to help them resist
temptations to smoke.

Control Intervention Condition

This control informational intervention has been used in the primary investigator's and
other's previous studies. In the current application, it will match the session time of the
working memory training and motivational enhancement components in the Enhanced Intervention
Condition, and will consist of discussions of a variety of healthy lifestyle topics, such as
healthy eating, stress/time management, and recommended health screenings (excluding
discussion of smoking, which will be addressed during the SCP component that is common to
both intervention conditions).

Inclusion Criteria:

- adults aged 18 or older, current smoker interested in participating in smoking
cessation treatment

Exclusion Criteria:

- Non-English speaking (operationalized as the inability to read and understand the
consent form and converse in spoken English), pregnancy
We found this trial at
1
site
930 Commonwealth Avenue
Boston, Massachusetts 02215
?
mi
from
Boston, MA
Click here to add this to my saved trials