## Protocol Section
### Identification Module
**NCT ID:** NCT00297479

**Brief Title:** Group Therapy for Nicotine Dependence: Mindfulness and Smoking

**Official Title:** Group Therapy for Nicotine Dependence

#### Organization Study ID Info
**ID:** 2004-0988
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**ID:** R01DA018875
**Link:** https://reporter.nih.gov/quickSearch/R01DA018875
**Type:** NIH
**Domain:** NCI CTRP
**ID:** NCI-2012-02081
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2016-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-06-16

**Type:** ACTUAL

**Last Update Submit Date:** 2020-06-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-06-16

**Type:** ACTUAL

**Results First Submit Date:** 2020-02-03

**Results First Submit QC Date:** 2020-06-03

#### Start Date
**Date:** 2005-04

**Status Verified Date:** 2020-06

#### Study First Post Date
**Date:** 2006-02-28
**Type:** ESTIMATED
**Study First Submit Date:** 2006-02-24
**Study First Submit QC Date:** 2006-02-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute on Drug Abuse (NIDA)

#### Lead Sponsor

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The goal of this behavioral research study is to create and study a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness is a method to help focus attention on being in the "here and now." It can be learned through training in how to control one's attention. It is usually taught through meditation. The overarching goals of the study are to evaluate the efficacy of MBAT for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.

**Detailed Description:** This 3-group randomized clinical trial will develop and evaluate a Mindfulness-Based Addiction Treatment (MBAT) for nicotine dependence. Mindfulness reflects a purposeful control of attention and can be learned through training in attentional control procedures.

Current cigarette smokers (N=550; 400 in formal study; up to 80-150 pilot) will be randomly assigned to Usual Care (UC), Standard Treatment (ST) or MBAT. UC will be four 5-10 minute counseling sessions following the problem-solving approach in the Treating Tobacco Use and Dependence Clinical Practice Guideline (Guideline). ST is a standard smoking cessation group program using a problem-solving/coping skills approach. MBAT is a group smoking cessation program derived from Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy. MBAT will not alter the basic mindfulness approach used in MBCT and MBSR, but will replace depression-related material with smoking cessation strategies from the Guideline. All participants will receive nicotine patches and self-help materials. MBAT mechanisms and effects will be assessed using "implicit" cognitive psychological measures and computer-administered questionnaires. Participants will be tracked from baseline through 4 (UC) or 8 (ST and MBAT) treatment visits and follow-up visits 1 and 23 weeks post-treatment.

The overarching goals are to evaluate MBAT's efficacy for nicotine dependence and the mechanisms and effects posited to mediate MBAT's impact on abstinence.

Primary specific aims are to:

1. Examine the effects of MBAT on abstinence rates
2. Examine the effects of MBAT on mindfulness/metacognitive awareness, attentional control, smoking automaticity, smoking associations in memory, negative affect, depression, stress, affect regulation expectancies, self-efficacy, withdrawal, and coping across the pre- and post-cessation period, and whether these variables mediate MBAT effects on abstinence.

### Conditions Module

**Conditions:**

- Smoking

- Tobacco Use Cessation

**Keywords:**

- Tobacco Cessation

- Smoking Cessation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 650

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** MBAT is 6 weeks of nicotine patch therapy; a Self-help guide; and In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence.

**Intervention Names:**

- Behavioral: MBAT Group Therapy

- Drug: Nicotine

**Label:** Mindfulness-Based Treatment Group (MBAT)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Standard Care Group (ST) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline

**Intervention Names:**

- Drug: Nicotine

- Behavioral: Group Therapy

**Label:** Standard Care Group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Usual Care (UC) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline

**Intervention Names:**

- Drug: Nicotine

- Behavioral: Individual Therapy

**Label:** Usual Care Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mindfulness-Based Treatment Group (MBAT)

**Description:** In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence

**Name:** MBAT Group Therapy

**Other Names:**

- therapy

- counseling

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Mindfulness-Based Treatment Group (MBAT)

- Standard Care Group

- Usual Care Group

**Description:** 6 weeks of nicotine patch therapy

**Name:** Nicotine

**Other Names:**

- nicotine patch therapy

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Standard Care Group

**Description:** In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline

**Name:** Group Therapy

**Other Names:**

- counseling

**Type:** BEHAVIORAL

#### Intervention 4

**Arm Group Labels:**

- Usual Care Group

**Description:** In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline

**Name:** Individual Therapy

**Other Names:**

- counseling

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.

**Measure:** Number of Participants With Smoking Abstinence

**Time Frame:** 4 weeks post quit day (one week following the end of treatment)

**Description:** Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

**Measure:** Smoking Abstinence

**Time Frame:** 26 weeks post quit day

**Description:** Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach

**Measure:** Smoking Abstinence

**Time Frame:** 4 weeks post quit day (one week following the end of treatment)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Age 18 or above
2. Current smoker with a history of at least five cigarettes/day for the past year
3. Motivated to quit within the next 30 days (preparation stage)
4. Participants must provide a viable home address and a functioning home telephone number
5. Can read and write in English
6. Register "8" or more on a carbon monoxide breath test
7. Provide viable collateral contact information

Exclusion Criteria:

1. Contraindication for nicotine patch use
2. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless tobacco)
3. Use of bupropion or nicotine patch replacement products other than the study patches
4. Pregnancy or lactation
5. Another household member enrolled in the study
6. Active substance dependence (exclusive of nicotine dependence)
7. Current psychiatric disorder; current use of psychotropic medication
8. Participation in a smoking cessation program or study during the past 90 days

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Houston

**Country:** United States

**Facility:** University of Texas MD Anderson Cancer Center

**State:** Texas

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** M.D. Anderson Cancer Center

**Name:** David W Wetter, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2.

**PMID:** 35420700

**Citation:** Vidrine JI, Businelle MS, Reitzel LR, Cao Y, Cinciripini PM, Marcus MT, Li Y, Wetter DW. Coping Mediates the Association of Mindfulness with Psychological Stress, Affect, and Depression Among Smokers Preparing to Quit. Mindfulness (N Y). 2015 Jun;6(3):433-443. doi: 10.1007/s12671-014-0276-4. Epub 2014 Jan 18.

**PMID:** 28191263

#### See Also Links

**Label:** University of Texas MD Anderson Cancer Center Website

**URL:** http://www.mdanderson.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M16785

- Name: Tobacco Use Disorder

- Relevance: HIGH

- As Found: Nicotine Dependence

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014029

- Term: Tobacco Use Disorder

### Intervention Browse Module - Ancestors

- ID: D000005731

- Term: Ganglionic Stimulants

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018722

- Term: Nicotinic Agonists

- ID: D000018679

- Term: Cholinergic Agonists

- ID: D000018678

- Term: Cholinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSSti

- Name: Central Nervous System Stimulants

### Intervention Browse Module - Browse Leaves

- ID: M12478

- Name: Nicotine

- Relevance: HIGH

- As Found: Prior to

- ID: M4029

- Name: Central Nervous System Stimulants

- Relevance: LOW

- As Found: Unknown

- ID: M20796

- Name: Nicotinic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20758

- Name: Cholinergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000009538

- Term: Nicotine

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events.No SAE's nor Adverse Events occurred in this protocol to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation report submission. 238 participants were registered under the pilot phase which were not included in the formal clinical trial and no data collected.participants.

#### Event Groups

**Group ID:** EG000

**Title:** Usual Care Group

**Description:** Usual Care (UC) 6 weeks of nicotine patch therapy, Self-help guide \& In-person individual counseling (4 sessions over 8 weeks)

**ID:** EG000

**Other Num at Risk:** 103

**Serious Number At Risk:** 103

**Title:** Usual Care Group

**Group ID:** EG001

**Title:** Standard Care Group

**Description:** Standard Care Group (ST) 6 weeks of nicotine patch therapy, Self-help guide \& In-person group therapy/counseling (8 sessions over 8 weeks)

**ID:** EG001

**Other Num at Risk:** 155

**Serious Number At Risk:** 155

**Title:** Standard Care Group

**Group ID:** EG002

**Title:** Mindfulness-Based Treatment Group (MBAT)

**Description:** MBAT 6 weeks of nicotine patch therapy; Self-help guide; \& In-person group therapy/counseling (8 sessions over 8 weeks) using a MBAT for nicotine dependence.

**ID:** EG002

**Other Num at Risk:** 154

**Serious Number At Risk:** 154

**Title:** Mindfulness-Based Treatment Group (MBAT)

**Frequency Threshold:** 0

**Time Frame:** Adverse event data collected up to 32 weeks of treatment.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 103

**Group ID:** BG001

**Value:** 155

**Group ID:** BG002

**Value:** 154

**Group ID:** BG003

**Value:** 412

**Units:** Participants

### Group

**ID:** BG000

**Title:** Usual Care Group (UC)

**Description:** 6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline

### Group

**ID:** BG001

**Title:** Cognitive Behavioral Treatment (CBT)

**Description:** 6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline

### Group

**ID:** BG002

**Title:** Mindfulness-Based Treatment Group (MBAT)

**Description:** 6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 103

#### Measurement

**Group ID:** BG001

**Value:** 155

#### Measurement

**Group ID:** BG002

**Value:** 154

#### Measurement

**Group ID:** BG003

**Value:** 412

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.5

**Value:** 49

#### Measurement

**Group ID:** BG001

**Spread:** 11.9

**Value:** 48.8

#### Measurement

**Group ID:** BG002

**Spread:** 11.7

**Value:** 48.4

#### Measurement

**Group ID:** BG003

**Spread:** 11.9

**Value:** 48.7

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 58

#### Measurement

**Group ID:** BG001

**Value:** 84

#### Measurement

**Group ID:** BG002

**Value:** 84

#### Measurement

**Group ID:** BG003

**Value:** 226

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 45

#### Measurement

**Group ID:** BG001

**Value:** 71

#### Measurement

**Group ID:** BG002

**Value:** 70

#### Measurement

**Group ID:** BG003

**Value:** 186

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 103

#### Measurement

**Group ID:** BG001

**Value:** 155

#### Measurement

**Group ID:** BG002

**Value:** 154

#### Measurement

**Group ID:** BG003

**Value:** 412

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 4.0

**Value:** 31.9

#### Measurement

**Group ID:** BG001

**Spread:** 3.6

**Value:** 31.9

#### Measurement

**Group ID:** BG002

**Spread:** 3.8

**Value:** 32.0

#### Measurement

**Group ID:** BG003

**Spread:** 3.8

**Value:** 32.0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** .9

**Value:** 4.2

#### Measurement

**Group ID:** BG001

**Spread:** .9

**Value:** 4.3

#### Measurement

**Group ID:** BG002

**Spread:** 1.0

**Value:** 4.3

#### Measurement

**Group ID:** BG003

**Spread:** .9

**Value:** 4.3

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 8.6

**Value:** 19.3

#### Measurement

**Group ID:** BG001

**Spread:** 9.3

**Value:** 19.9

#### Measurement

**Group ID:** BG002

**Spread:** 11.7

**Value:** 20.3

#### Measurement

**Group ID:** BG003

**Spread:** 10.1

**Value:** 19.9

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 39

#### Measurement

**Group ID:** BG001

**Value:** 61

#### Measurement

**Group ID:** BG002

**Value:** 59

#### Measurement

**Group ID:** BG003

**Value:** 159

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 14

#### Measurement

**Group ID:** BG003

**Value:** 37

**Class Title:** < High School

#### Measurement

**Group ID:** BG000

**Value:** 25

#### Measurement

**Group ID:** BG001

**Value:** 37

#### Measurement

**Group ID:** BG002

**Value:** 39

#### Measurement

**Group ID:** BG003

**Value:** 101

**Class Title:** High School/GED

#### Measurement

**Group ID:** BG000

**Value:** 52

#### Measurement

**Group ID:** BG001

**Value:** 76

#### Measurement

**Group ID:** BG002

**Value:** 67

#### Measurement

**Group ID:** BG003

**Value:** 195

**Class Title:** Some College

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 28

#### Measurement

**Group ID:** BG003

**Value:** 55

**Class Title:** 4-year College Degree

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 23

**Class Title:** > 4-year College Degree

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 61

#### Measurement

**Group ID:** BG001

**Value:** 89

#### Measurement

**Group ID:** BG002

**Value:** 87

#### Measurement

**Group ID:** BG003

**Value:** 237

**Class Title:** < $30,000/year

#### Measurement

**Group ID:** BG000

**Value:** 42

#### Measurement

**Group ID:** BG001

**Value:** 66

#### Measurement

**Group ID:** BG002

**Value:** 67

#### Measurement

**Group ID:** BG003

**Value:** 175

**Class Title:** > $30,000/year

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 76

#### Measurement

**Group ID:** BG001

**Value:** 103

#### Measurement

**Group ID:** BG002

**Value:** 109

#### Measurement

**Group ID:** BG003

**Value:** 288

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 27

#### Measurement

**Group ID:** BG002

**Value:** 22

#### Measurement

**Group ID:** BG003

**Value:** 71

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Description:** The Kentucky Inventory of Mindfulness Skills (KIMS) is a self-report inventory for the assessment of mindfulness skills (including subscales for observing (15-59), describing (10-40), acting with awareness (15-48), and accept(13-45) . Items are rated on a 5 point Likert scale ranging from 1 (never or very rarely true) to 5 (almost always or always true). Items reflect either direct descriptions of the mindfulness skills, or they describe the absence of that skill and are reverse scored. The minimum score 10 and maximum score 59. Higher-scores reflect more mindfulness.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Kentucky Inventory of Mindfulness Skills (KIMS)
**Unit of Measure:** KIMS Score
### Measure 6
**Description:** The Mindful Attention Awareness Scale (MAAS) is a 15 item self-report questionnaire measuring mindfulness. To score the scale, simply compute a mean (average) of the 15 items. Items are rated on using the 1-6 scale ranging from 1 (almost always) to 6 (almost never). Indicates currently how frequently or infrequently each experience.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Mindful Attention Awareness Scale (MAAS)
**Unit of Measure:** MAAS Score
### Measure 7
**Description:** Nicotine Dependence was assessed at baseline using the Heaviness of Smoking Index (HIS). The HSI comprises the two items from the Fagerstrom Test for Nicotine Dependence (FTND) that most strongly predict smoking relapse, cigarettes per day (CPD) and minutes to the first cigarette after waking.
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Nicotine Dependence - Cigarettes per day
**Unit of Measure:** Cigarettes per day
### Measure 8
**Description:** Nicotine Dependence was assessed at baseline using the Heaviness of Smoking Index (HIS). The HSI comprises the two items from the Fagerstrom Test for Nicotine Dependence (FTND) that most strongly predict smoking relapse, cigarettes per day (CPD) and minutes to the first cigarette after waking.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Nicotine Dependence - Participants reported smoking their first cigarette with 5 minutes of walking
**Unit of Measure:** Participants
### Measure 9
**Description:** Years of Education
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Demographics (Education)
**Unit of Measure:** Participants
### Measure 10
**Description:** Income: self-reported household income
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Demographics (Household Income)
**Unit of Measure:** Participants
### Measure 11
**Description:** Relationship status: self-report of participants with no partner
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Demographics (Spouse/Partner)
**Unit of Measure:** Participants
### Measure 12
**Description:** The Center of Epidemiologic Studies Depression Scale (CES-D) assesses depressive symptoms in community non-clinical populations
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Demographics (History of Depression)
**Unit of Measure:** Participants
**Population Description:** 238 were registered under the pilot phase which were not included in the formal clinical trial and no data collected for those 238 participants.
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** sgiordan@mdanderson.org
**Organization:** UT MD Anderson Cancer Center
**Phone:** 713-563-0020
**Title:** Dr. Sharon Giordano, MD/Chair, Health Svcs Research-Clinical
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 39
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 43
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 52
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Biochemically verified 7-day point prevalence abstinence rates based on a completers-only approach.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Completers-only
**Reporting Status:** POSTED
**Time Frame:** 4 weeks post quit day (one week following the end of treatment)
**Title:** Number of Participants With Smoking Abstinence
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline
**ID:** OG000
**Title:** Usual Care Group (UC)
##### Group
**Description:** 6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline
**ID:** OG001
**Title:** Cognitive Behavioral Treatment (CBT)
##### Group
**Description:** 6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
**ID:** OG002
**Title:** Mindfulness-Based Treatment Group (MBAT)
#### Outcome Measure 2
**Description:** Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Completers Only
**Reporting Status:** POSTED
**Time Frame:** 26 weeks post quit day
**Title:** Smoking Abstinence
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline
**ID:** OG000
**Title:** Usual Care Group (UC)
##### Group
**Description:** 6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline
**ID:** OG001
**Title:** Cognitive Behavioral Treatment (CBT)
##### Group
**Description:** 6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
**ID:** OG002
**Title:** Mindfulness-Based Treatment Group (MBAT)
#### Outcome Measure 3
**Description:** Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Intent to treat
**Reporting Status:** POSTED
**Time Frame:** 4 weeks post quit day (one week following the end of treatment)
**Title:** Smoking Abstinence
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline
**ID:** OG000
**Title:** Usual Care Group (UC)
##### Group
**Description:** 6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline
**ID:** OG001
**Title:** Cognitive Behavioral Treatment (CBT)
##### Group
**Description:** 6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
**ID:** OG002
**Title:** Mindfulness-Based Treatment Group (MBAT)
#### Outcome Measure 4
**Description:** Biochemically verified 7-day point prevalence abstinence rates using an intent-to-treat approach
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Intent to treat
**Reporting Status:** POSTED
**Time Frame:** 26 weeks post quit day
**Title:** Smoking Abstinence
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** 6 wks of nicotine patch therapy, self-help guide and in-person individual counseling (4 sessions in 8 weeks) based on Tobacco Use and Dependence Clinical Practice Guideline
**ID:** OG000
**Title:** Usual Care Group (UC)
##### Group
**Description:** 6 wks of nicotine patch therapy, self-help guide and in-person group counseling (8 sessions in 8 weeks) based on Treating Tobacco Use and Dependence Clinical Practice Guideline
**ID:** OG001
**Title:** Cognitive Behavioral Treatment (CBT)
##### Group
**Description:** 6 wks of nicotine patch therapy; self-help guide; and in-person group counseling (8 sessions in 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence
**ID:** OG002
**Title:** Mindfulness-Based Treatment Group (MBAT)
### Participant Flow Module
#### Group
**Description:** Usual Care (UC) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person individual counseling (4 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
**ID:** FG000
**Title:** Usual Care Group
#### Group
**Description:** Standard Care Group (ST) is 6 weeks of nicotine patch therapy, a Self-help guide and In-person group therapy/counseling (8 sessions over 8 weeks) based upon Treating Tobacco Use and Dependence Clinical Practice Guideline
**ID:** FG001
**Title:** Cognitive Behavioral Treatment (CBT)
#### Group
**Description:** MBAT is 6 weeks of nicotine patch therapy; a Self-help guide; and In-person group therapy/counseling (8 sessions over 8 weeks) using a Mindfulness-Based Addiction Treatment for nicotine dependence.
**ID:** FG002
**Title:** Mindfulness-Based Treatment Group (MBAT)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 37
###### Reason
**Group ID:** FG001
**Number of Subjects:** 54
###### Reason
**Group ID:** FG002
**Number of Subjects:** 51
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 103
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 155
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 154
##### Milestone
**Type:** 4-Week Follow Up
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 78
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 132
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 128
##### Milestone
**Type:** 26- Week Follow Up
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 66
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 101
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 103
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 66
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 101
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 103
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 37
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 54
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 51
**Pre-Assignment Details:** Out of the 650 participants, 412 were on the formal clinical trial and 238 were registered under the pilot phase which were not included in the formal clinical trial and no data collected for those 238 participants.
**Recruitment Details:** Participants were recruited from the Houston metropolitan area via local print media. All data collected between January 2007 to February 2010.
**Has Results:** True