Trial Information

A Mood Management Intervention for Pregnant Smokers

Before treatment begins, you will have a screening visit with the study doctor/staff, to
find out if you are eligible to take part in the study. This visit will involve an in-depth
interview about your history of depression and other mental health problems. If you have not
yet been to a doctor, the study staff will give you a urine pregnancy test to make sure you
are pregnant.You will also be asked to complete several questionnaires regarding smoking
history and other areas of your daily life. The questionnaires themselves take about 30-45
minutes to complete. The visit may last between 1 1/2 and 3 1/2 hours, depending on the
complexity of the interview.

If you are eligible to take part in the study, you will receive one of two types of smoking
cessation counseling. In one, counseling will focus on health concerns related to
pregnancy, information about smoking and pregnancy, tips for quitting, and problem-solving
skills to manage situations that might be triggers for smoking. In the other, counseling
will focus on the learning to manage negative moods (depressed mood, tension, anxiety), as
well as providing tips for quitting smoking, problem-solving skills, and information about
smoking and pregnancy. Counseling sessions for both groups will last about an hour each.

During the first counseling visit, you will set a quit date for stopping smoking.

At each of the counseling visits, you will also be asked to provide a carbon monoxide (CO)
measurement. This is done by blowing into a cardboard tube attached to a CO monitor. This
will show whether or not you are still smoking. You will also complete several
questionnaires at every visit, which will take about 20-40 minutes. These questionnaires
will include questions about your mood, confidence in quitting, smoking behavior, and social
support.

Four times during the study, you will provide a saliva sample for tests to look for
cotinine, a chemical produced by the breakdown of nicotine during smoking. This sample will
be taken using a dental roll (cotton swab) placed in the mouth for several minutes to absorb
saliva. Like the CO test, this test will help researchers measure how much you are smoking.

You will be asked to attend a maximum of 12 individual counseling sessions, over a 2-3 month
period. Also, you will receive 4 follow-up telephone calls from the study staff. These
calls will take place 2 weeks after treatment ends, 2 weeks before your due date, 2 weeks
after your delivery, and 4 weeks after your delivery.

Additional in-person clinic visits will take place at 3- and 6-months after your delivery.
During these visits you will be asked to provide carbon monoxide (CO) and cotinine
measurements of your smoking and to complete a packet of questionnaires regarding your mood,
social support, and smoking behavior.

So that the study researchers can keep in contact with you throughout the study and over the
long period of time between your end of treatment visit and the 3- and 6-month postpartum
follow-up visits, you will be asked at the baseline visit to provide the name and address of
3 contacts (family members/friends) that you feel confident would have updated contact
information on you. You will also be asked to sign a letter giving your contacts permission
to provide your updated information to the study staff. The staff will check this contact
information at the end-of-treatment visit, at one of the telephone assessment calls and then
again at the 3-month follow-up visit.

If the study staff is not able to reach you by phone, mail, or the information provided by
your contacts, they may attempt to locate you through telephone directory assistance (411)
or internet search sources (for example, Google or Yahoo!), which use information from the
public domain (meaning everyone has access to it).

If the study staff is still unable to locate your new contact information, they may use a
locator service such as Transunion or the National Change of Address (NCOA) database
maintained by the United States Postal Service, as a last resort. Transunion uses things
like magazine subscriptions and credit applications to find new addresses, and the NCOA uses
the Change of Address cards filed with the post office when a person moves and requests
their mail be forwarded to a new address. If the study staff has to use either of these
services, they would only disclose your name and last known address.

Researchers may also use Temporary Assistance for Needy Families (Welfare)/Medicaid
Administrative databases, maintained by the Texas Department of Human Services (TDHS), to
find contact information for participants who cannot be found for follow-up study. The
study staff will provide designated Welfare personnel with a list containing the name, date
of birth, last known address, and other relevant personal identifiers for each of the
participants with whom we cannot contact. In return, Welfare personnel will provide study
staff with the most recent locator information (such as address and phone numbers) for each
of the listed participants.

Under certain circumstances, your counselor may provide counseling to you over the phone.
Additionally, you may be mailed some questionnaires and/or a cotinine sample kit. If so, a
pre-addressed, postage paid envelope will be provided for the return of these materials.

Each of the counseling sessions will be videotaped. In addition, the SCID assessment done
at the Baseline visit and the LIFE Assessment done at both follow-up visits, may be
videotaped or audiotaped to make sure you are being rated correctly. The videotapes, will
be erased within one year following your completion of the study. The videotapes will be
used to help the investigators make sure that the counselors are following the correct
procedures and may be used in future studies to help the investigators better understand the
mood management and behavioral counseling treatments. No one but the study investigators or
those delegated by the study investigators will be allowed to view the tapes and the
identity of the participants will be kept strictly confidential. Staff that may be given
permission by the study investigators to view the tapes include project staff, consultants
that review and rate how well the study therapists giving the intervention follow study
guidelines, and/or consultants that review how the assessments are given.

This is an investigational study. Up to 450 women will take part in this study. All will
be enrolled at M. D. Anderson.