Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505869
Status:
COMPLETED
Last Update Posted:
2012-08-02
First Post:
2007-07-23
Brief Title:
A Mood Management Intervention for Pregnant Smokers
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Mood Management Intervention for Pregnant Smokers
Status:
COMPLETED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This proposal is aimed at testing the following hypotheses
1 Cessation rates will be significantly greater for smokers in a mood management condition versus a health wellness condition during pregnancy and at 3 and 6 months postpartum
2 Pregnant smokers who have a higher level of depressive symptomatology will quit significantly less often in the health wellness condition vs mood management condition those with a lower level of depressive symptomatology will not demonstrate this treatment difference
3 Pregnant smokers who show higher levels of current depression at the start of the intervention will quit significantly less often than those smokers with lower levels
The mood management intervention will result in higher levels of adaptive coping behavior self-efficacy social support and perceived support from the counselor and lower levels of negative affect rumination and perceived stress than the health wellness intervention and these variables will be related to abstinence Thus we will evaluate the effects of the intervention health wellness and mood management on hypothesized treatment mechanisms and assess the impact of those mechanisms on abstinence
1 Cessation rates will be significantly greater for smokers in a mood management condition versus a health wellness condition during pregnancy and at 3 and 6 months postpartum
2 Pregnant smokers who have a higher level of depressive symptomatology will quit significantly less often in the health wellness condition vs mood management condition those with a lower level of depressive symptomatology will not demonstrate this treatment difference
3 Pregnant smokers who show higher levels of current depression at the start of the intervention will quit significantly less often than those smokers with lower levels
The mood management intervention will result in higher levels of adaptive coping behavior self-efficacy social support and perceived support from the counselor and lower levels of negative affect rumination and perceived stress than the health wellness intervention and these variables will be related to abstinence Thus we will evaluate the effects of the intervention health wellness and mood management on hypothesized treatment mechanisms and assess the impact of those mechanisms on abstinence
Detailed Description:
Before treatment begins you will have a screening visit with the study doctorstaff 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 pregnantYou 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 12 and 3 12 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 membersfriends 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 WelfareMedicaid 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 andor 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 andor 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
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 membersfriends 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 WelfareMedicaid 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 andor 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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None