Mindfulness Training for Smokers Online Feasibility Study

The MTS Online Feasibility Study is funded for through a five-year K23 NIH training grant
awarded to Dr. James Davis, the Principal Investigator on this protocol. The study
enrollment goal is N=50 adult smokers. MTS Online is an Internet-based smoking cessation
intervention that provides access to video material and instructional support for 8
mindfulness classes over a 6-week period. The MTS Online Feasibility Study aims to explore
the feasibility of an Internet-based version of MTS, specifically looking at issues of
on-line participation and Internet site use, adherence to instructed mindfulness practice
regimen, and overall acceptability of MTS Online to a smoking population.

Participants will be recruited for MTS Online through existing recruitment mechanisms
already in place for MTS. Specifically, participants who decline or are excluded from the
MTS Study due solely to scheduling conflicts will be offered participation in MTS Online.
All other inclusion/exclusion criteria are identical to the MTS study and discussed below.

After a decline or exclusion from the MTS Study due to scheduling and no other reason,
research assistant will ask the caller if they would like the phone number for the Wisconsin
Tobacco Quit Line and will ask the caller if they would like to hear about an online version
of the MTS program. If the participant says they are interested, the RA will read a
description of the online program and phone screening through the MTS Online Phone Screening
Script. This script includes all inclusion and exclusion criteria found in the MTS Study,
with the exception of the question on whether the caller can attend all the class meetings.
If at the end of the phone script, the caller decides that they would like to come in for an
Orientation Meeting, they will be sent an email providing instructions for scheduling their
Orientation Meeting.

During the Orientation Meeting/Study Visit 1 MTS staff will provide a general description of
the study and review the study consent form. If potential participants choose to join the
study they will sign the consent form. After signing consent potential participants will be
provided instruction on the use of nicotine patches, smoking calendars and will be provided
with intervention materials. Research Assistants will assist participants as they log onto
the MTS Online website and create a unique user ID. This ID will be used for all MTS Online
features including communicating through the online forum and viewing instructional videos.
Potential participants will be given a course schedule with a "class time" for their first
class. After this, participants will fill out a Scan Form Questionnaire and proceed to
collection of clinical measurements.

Intervention/Study Sign Up: During the Orientation potential participants will be provided
with instructions on how to sign up for the intervention and study. This will include the
following steps that must be completed through the individual's own Internet access (i.e.
not completed at UW-CTRI).

1. Sign on to the MTS Online Forum using the username and password provided during the
orientation.

2. Respond to the question "Do you want to join the MTS Online Study?" with the answer
"Yes." Participants will be asked to review Class 1 in the MTS Instructional Video and
MTS Manual before or during the time scheduled for Class 1. After this time,
participants will be asked begin using various mindfulness practices and answer some
questions provided by their instructor on how the practices went. This takes place
primarily on the MTS Forum where other class participants can benefit from the
interaction. Participants will, however, also have access to the instructors email
address for private interactions.

Nicotine Replacement Therapy (NRT): All participants will receive two weeks of nicotine
patches to start on their Quit Day. Patches will be provided by the MTS Study and mailed
directly to PO Box or home address provided by participants approximately 10 days prior to
their Quit Day (to assure ample time for delivery). Patch dosing for all participants will
be as follows:

14 mg patches for participants who smoke 10 or fewer cigarettes per day 21 mg patches for
participants who smoke over 10 cigarettes per day

MTS Online: Participants will have access to 8 classes over a 6-week period through the MTS
Online website - www.sittoquit.org. The first 5 classes include instruction through the MTS
Instructional Video and MTS Manual. The last 3 classes are provided through materials in the
MTS Manual alone. The MTS website contains forum designed specifically for the MTS Online
Participants. On this forum, MTS Online Feasibility Study participants can discuss topics
related to smoking and mindfulness in discussion groups moderated by MTS mindfulness
instructors. Participants will also be provided with the MTS Audio-CD that contains guided
mindfulness exercises.

MTS Online Classes: MTS Online classes are provided through the MTS Instructional Video and
MTS Manual. The classes provide instruction in mindfulness mediation, mindful walking,
mindful eating, and other mindfulness exercises. MTS Online classes provide instruction on
how to use mindfulness skills to manage relapse challenges such as smoking triggers,
craving, withdrawal symptoms, strong emotions, and stressful situations. The forum serves as
a quit smoking support group and provides a place for participants to learn from one
another's challenges and through the guidance of a mindfulness instructor. MTS Online
classes are available through the MTS Online website. The classes will follow a regular
schedule in which participants are to have watched the video material by a certain date (see
course schedule above). Following this time, a forum discussion will begin on the website,
moderated by the MTS Online mindfulness instructor.

MTS Online Quit Day: Guidelines will be provided to participants for conducting their own
personal Quit Day. Participants are encouraged to set aside additional time for mindfulness
practice during their Quit Day. Online forum discussion will also take place on the Quit
Day. Nicotine patches will be started on the Quit Day and will be continued for 2 weeks.

MTS Online Instructors: Five instructors will moderate various waves of MTS Online. These
five include the three instructors who have been trained to teach the Mindfulness Training
for Smokers Intervention (see Key Personnel). In addition, the study PI, Dr. James Davis,
and a graduate student working on the project, Simon Goldberg, will co-facilitate the early
waves. All five MTS Online instructors have completed UW IRB modules provided for Research
on Human Subjects. The three MTS instructors have been teaching the MTS course for the last
12 months. MTS Instructors have education the equivalent of a BA/BS or higher and have 2 or
more years experience teaching meditation and mindfulness practices. MTS Instructors have
completed the MTS Instructor Training Course provided over a weekend. MTS Instructor
Training includes standard methods normally provided at CTRI including HIPPA training and
UW-IRB training for individuals involved in research on human subjects. Instructor Training
also includes instruction on how to conduct MTS including training to familiarize
instructors with the MTS Instructional Video, MTS Audio CD and MTS Manual. The list of Key
Personnel on the IRB protocol will be updated as new instructors are trained.

MTS Instructional Video: The MTS Instructional Video is a 2-hour DVD course with interviews
provided by multiple nationally recognized experts on mindfulness and smoking addiction. It
describes how to apply mindfulness to overcome obstacles in smoking addiction. The video is
divided into five chapters, one chapter for each class prior to the Quit Day. Most chapters
are 15- 20 minutes long. The chapters will provide the primary course material for MTS
Online. Participants will be instructed to watch portions of the video on a pre-specified
schedule (see above) and participate in forum discussion on topics addressed in the video.

MTS Manual: The MTS Manual contains organizational materials, conceptual information and
class exercises. It follows the format of the MTS Video but expands on the information. The
manual is intended to reinforce and expand participants understanding of how to use
mindfulness to quit smoking.

MTS Website: The MTS website is available through the URL: www.sittoquit.org. The MTS
website contains a 2-minute video on the homepage that provides information on the study and
intervention. MTS Online participants will be able to gain access to other parts of the web
site by use of a unique login name and password created during the Orientation Meeting/Study
Visit 1. The MTS website contains a meeting calendar, the MTS Instructional Video, the MTS
Manual and the MTS Online Forum specially designed so that participants in the MTS Online
Feasibility Study can interact with MTS Instructors and other participants. An additional
forum exists for non-Online participants (i.e. participants in the non-online MTS study).
The website is maintained through University of Wisconsin information technology services.
Activity on the web site will be monitored by the PI and by a UW CTRI IT specialist.

Daily Meditation/MTS Audio CD: MTS Online participants will be asked to meditate each day
with the MTS Audio CD starting after their first mindfulness class and continuing until 1
month after their Quit Day, although participants will be encouraged to practice meditation
indefinitely. The MTS Audio-CD contains a 15-minute and a 30-minute guided meditation
practice. The CD was made by Dr. James Davis and provides instructions for mindfulness
meditation.

Inclusion Criteria:

1. Age: 18 years or over

2. Participants must express "high" motivation to quit smoking

3. Participants must smoke 5 or more cigarettes per day

Exclusion Criteria:

1. Self report of alcohol use of 4 drinks or more a night on 4 or more nights per week.

2. Self report of using chewing tobacco, snuff or cigars in the last week

3. Severe depression or suicidality as assessed via the Patient Health Questionnaire
(see section below for details)