Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00494728
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2007-06-28
Brief Title:
Smoking Cessation for Depressed Smokers
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Smoking Cessation Intervention for Depressed Smokers Treatment Development
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
Objectives
Primary Aim
To conduct a preliminary randomized trial in smokers with current recurrent major depressive disorder MDD current MDD with a single episode of 2 years or more and current dysthymia comparing combined cognitive behavioral analysis system of psychotherapy CBASP and standard smoking cessation treatment ST CBASPST to combined Health Education and ST treatment HEST to
1 Examine the effects of CBASPST on both short and long-term point prevalence abstinence
Secondary Aims
1 To test the hypothesis that depressed smokers in the CBASPST treatment will experience greater decreases in depressive symptoms from baseline to each of our follow-up assessment points compared to depressed smokers in the HEST treatment and
2 That depressed smokers in the CBASPST treatment will experience greater improvements in psychosocial functioning from baseline to follow-up assessment points compared to depressed smokers in the ST treatment
3 To evaluate between subject neurophysiological predictors of abstinence at 3 and 6 months and
4 To evaluate within-subject changes in neurophysiological responses to emotional and smoking-related stimuli across treatment sessions and the relation of these changes to abstinence and depressive symptoms at end of treatment and 3- and 6-months
Primary Aim
To conduct a preliminary randomized trial in smokers with current recurrent major depressive disorder MDD current MDD with a single episode of 2 years or more and current dysthymia comparing combined cognitive behavioral analysis system of psychotherapy CBASP and standard smoking cessation treatment ST CBASPST to combined Health Education and ST treatment HEST to
1 Examine the effects of CBASPST on both short and long-term point prevalence abstinence
Secondary Aims
1 To test the hypothesis that depressed smokers in the CBASPST treatment will experience greater decreases in depressive symptoms from baseline to each of our follow-up assessment points compared to depressed smokers in the HEST treatment and
2 That depressed smokers in the CBASPST treatment will experience greater improvements in psychosocial functioning from baseline to follow-up assessment points compared to depressed smokers in the ST treatment
3 To evaluate between subject neurophysiological predictors of abstinence at 3 and 6 months and
4 To evaluate within-subject changes in neurophysiological responses to emotional and smoking-related stimuli across treatment sessions and the relation of these changes to abstinence and depressive symptoms at end of treatment and 3- and 6-months
Detailed Description:
During the session today you will be asked to complete 8-9 questionnaires about smoking history health status current medications you are taking your confidence in quitting smoking symptoms of nicotine dependence and withdrawal symptoms of depression negative experiences during childhood and your thoughts and feelings about work and the quality of your relationships with others In total the questionnaires should take about 30-45 minutes to complete You will also blow into a machine that measures the amount of carbon monoxide in your blood a breath test This visit may last 1 ½ to 2 hours
Following the session today you will be provided with information on the results of the screening tests you completed at BCM to see whether you have a current depressive disorder or any other psychiatric disorders You will be provided with an opportunity to discuss this information with the investigators
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of a coin to one of 2 groups If you are assigned to Group 1 you will receive counseling to help develop behavioral coping skills that will help with situations where you are tempted to smoke more which are considered high-risk situations combined with mood management counseling to help you develop interpersonal communication coping skills to help with depression and negative moods that may affect your ability to quit smoking If you are assigned to Group 2 you will receive counseling to help develop behavioral coping skills that will help with situations where you are tempted to smoke more which are considered high-risk situations combined with education on the health-related effects of smoking Participants in both groups will receive nicotine patches
During the 5 weeks after the visit you will have six 6 70-minute counseling sessions
If you are in Group 1 you will receive information on how cigarette smoking is a learned habit and a physical addiction and how the habit can be unlearned You will receive counseling to help you identify situations that are high risk for smoking and to help you develop behavioral coping plans to decrease the chances of smoking in those situations You will be encouraged to use these skills between sessions You will also receive counseling to help you identify situations where you interact with others that may cause negative moods You will be taught interpersonal coping skills to help decrease depression and negative moods and to increase your ability to quit smoking and not start again You will be given homework assignments that will help you practice these skills between sessions
If you are in Group 2 you will receive information on how cigarette smoking is a learned habit and a physical addiction and how the habit can be unlearned You will also receive counseling to help you identify situations that are high risk for smoking and to help you develop behavioral coping plans to decrease the chances of smoking in those situations You will be encouraged to use these skills between sessions You will also receive information about health issues related to smoking and you will have the opportunity to discuss this information with your counselor
Before or after each of the counseling sessions you will fill out 2-3 questionnaires on mood and smoking behavior and have a breath test You will be asked to fill out 5-6 questionnaires on withdrawal symptoms confidence in quitting smoking your thoughts and feelings about work and the quality of your relationships with others In total it will should about 30-45 minutes to fill out the questionnaires at each visit Each of these visits will take a total of about 1 hour and 40 minutes to 1 hour and 55 minutes
The date to quit smoking will be scheduled for about 5 weeks after your first visit As part of your counseling sessions you will be provided with counseling to help you develop a plan to quit and to set a quit date You will be given the nicotine patches starting on the quit date You will be asked to wear the nicotine patches on the upper area of your body for 24 hours each day
Following the quit date you will attend six 6 more 70-minute counseling sessions You will also attend 2 additional visits at 3 months and 6 months from your quit date At each of these visits you will be asked to fill out 2-3 questionnaires on mood and smoking behavior and to provide a breath test to measure the amount of carbon monoxide in your blood You will be asked questions about symptoms you may be having and the medications you are taking You will be asked to fill out 5-6 questionnaires on withdrawal symptoms confidence in quitting smoking and the quality of your relationships with others at some of these visits If you are unable to attend your end-of-treatment 3-month or 6-month visits you may be asked to provide a saliva sample to measure the amount of cotinine in your blood 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 At the 3-month and 6-month follow-up visits you will be also asked questions about any current problems with depression
At the last treatment visit Visit 12 and at the 3-month and 6-month follow-up visits if you are still smoking you will be provided with information on where you can receive additional help to quit smoking If you continue to have a current depressive disorder you will be provided with additional information about this disorder and you will be provided with information on where you can receive treatment for your depressive disorder The investigators will provide a referral for treatment if you wish to receive treatment for your depressive disorder at that time
Each of the counseling visits will be videotaped In addition the first visit and the visits at 3 and 6 months may also be videotaped The videotapes will be erased within 1 year after you complete this study The videotapes will be used to help the investigators make sure that the counselors are following the correct therapy procedures and may be used in future studies to help the investigators better understand the mood management and health education treatments No one but the study investigators study staff and consultants those who review and rate how well the study therapists follow therapy procedures will be allowed to view the tapes Your identity will be kept strictly confidential
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 follow-up visits you will be asked at the baseline visit to provide the name and address of 2 contacts family membersfriends that you feel confident would have updated contact information on you
Your participation in this study will end after the 6-month follow-up visit
This is an investigational study The nicotine patches are FDA approved for use in adults age 18 and older and commercially available Up to 202 people will take part in this study All will be enrolled at M D Anderson
Following the session today you will be provided with information on the results of the screening tests you completed at BCM to see whether you have a current depressive disorder or any other psychiatric disorders You will be provided with an opportunity to discuss this information with the investigators
If you are found to be eligible to take part in this study you will be randomly assigned as in the toss of a coin to one of 2 groups If you are assigned to Group 1 you will receive counseling to help develop behavioral coping skills that will help with situations where you are tempted to smoke more which are considered high-risk situations combined with mood management counseling to help you develop interpersonal communication coping skills to help with depression and negative moods that may affect your ability to quit smoking If you are assigned to Group 2 you will receive counseling to help develop behavioral coping skills that will help with situations where you are tempted to smoke more which are considered high-risk situations combined with education on the health-related effects of smoking Participants in both groups will receive nicotine patches
During the 5 weeks after the visit you will have six 6 70-minute counseling sessions
If you are in Group 1 you will receive information on how cigarette smoking is a learned habit and a physical addiction and how the habit can be unlearned You will receive counseling to help you identify situations that are high risk for smoking and to help you develop behavioral coping plans to decrease the chances of smoking in those situations You will be encouraged to use these skills between sessions You will also receive counseling to help you identify situations where you interact with others that may cause negative moods You will be taught interpersonal coping skills to help decrease depression and negative moods and to increase your ability to quit smoking and not start again You will be given homework assignments that will help you practice these skills between sessions
If you are in Group 2 you will receive information on how cigarette smoking is a learned habit and a physical addiction and how the habit can be unlearned You will also receive counseling to help you identify situations that are high risk for smoking and to help you develop behavioral coping plans to decrease the chances of smoking in those situations You will be encouraged to use these skills between sessions You will also receive information about health issues related to smoking and you will have the opportunity to discuss this information with your counselor
Before or after each of the counseling sessions you will fill out 2-3 questionnaires on mood and smoking behavior and have a breath test You will be asked to fill out 5-6 questionnaires on withdrawal symptoms confidence in quitting smoking your thoughts and feelings about work and the quality of your relationships with others In total it will should about 30-45 minutes to fill out the questionnaires at each visit Each of these visits will take a total of about 1 hour and 40 minutes to 1 hour and 55 minutes
The date to quit smoking will be scheduled for about 5 weeks after your first visit As part of your counseling sessions you will be provided with counseling to help you develop a plan to quit and to set a quit date You will be given the nicotine patches starting on the quit date You will be asked to wear the nicotine patches on the upper area of your body for 24 hours each day
Following the quit date you will attend six 6 more 70-minute counseling sessions You will also attend 2 additional visits at 3 months and 6 months from your quit date At each of these visits you will be asked to fill out 2-3 questionnaires on mood and smoking behavior and to provide a breath test to measure the amount of carbon monoxide in your blood You will be asked questions about symptoms you may be having and the medications you are taking You will be asked to fill out 5-6 questionnaires on withdrawal symptoms confidence in quitting smoking and the quality of your relationships with others at some of these visits If you are unable to attend your end-of-treatment 3-month or 6-month visits you may be asked to provide a saliva sample to measure the amount of cotinine in your blood 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 At the 3-month and 6-month follow-up visits you will be also asked questions about any current problems with depression
At the last treatment visit Visit 12 and at the 3-month and 6-month follow-up visits if you are still smoking you will be provided with information on where you can receive additional help to quit smoking If you continue to have a current depressive disorder you will be provided with additional information about this disorder and you will be provided with information on where you can receive treatment for your depressive disorder The investigators will provide a referral for treatment if you wish to receive treatment for your depressive disorder at that time
Each of the counseling visits will be videotaped In addition the first visit and the visits at 3 and 6 months may also be videotaped The videotapes will be erased within 1 year after you complete this study The videotapes will be used to help the investigators make sure that the counselors are following the correct therapy procedures and may be used in future studies to help the investigators better understand the mood management and health education treatments No one but the study investigators study staff and consultants those who review and rate how well the study therapists follow therapy procedures will be allowed to view the tapes Your identity will be kept strictly confidential
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 follow-up visits you will be asked at the baseline visit to provide the name and address of 2 contacts family membersfriends that you feel confident would have updated contact information on you
Your participation in this study will end after the 6-month follow-up visit
This is an investigational study The nicotine patches are FDA approved for use in adults age 18 and older and commercially available Up to 202 people 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?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01MH087692 | NIH | NCI CTRP | httpsreporternihgovquickSearch1R01MH087692 |
| NCI-2012-02097 | REGISTRY | None | None |
| 1R01MH076776-01A1 | NIH | None | None |