Smoking Cessation
Conditions
Brief summary
The purpose of this study is to test the effects of a group smoking cessation program. The study will also examine individual differences in response to the intervention program.
Interventions
BEHAVIORALGroup Cognitive Behavioral Therapy
The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include a functional analysis of smoking patterns, environmental cues, and motivation for change, and cover nicotine addiction and withdrawal, health consequences, benefits of cessation, stress management, negative affect, alcohol use, triggers, coping responses, cognitive restructuring, social support, decision making, weight control, and physical activity.
BEHAVIORALGeneral Health Education
The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include didactic information on tobacco-associated morbidities, such as heart disease, diabetes, and hypertension. Content may include Power Point-delivered lectures on the prevalence, etiology, basic pathology, symptom patterns, and treatment of the conditions, and discussion questions designed to facilitate learning and interest. Smoking cessation specific topics will not be addressed, and coping skills will not be provided. Participants will be allowed to share feelings regarding smoking (if they mention them) and general questions will be answered, although no specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere to the TNP protocol).
DRUGTransdermal Nicotine Patch
Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
James and Esther King Biomedical Research Program
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Self-identify as African American/Black, Hispanic (any race), or White non-Hispanic * Smoke at least 5 cigarettes/day or carbon monoxide (CO) reading of at least 8 ppm * be over age 18 * speak/read English and/or Spanish
Exclusion criteria
* Contraindications for transdermal nicotine patch therapy (TNP) * Cognitive or mental health impairment that inhibits group treatment * Currently being treated for smoking cessation, alcoholism, or illicit drug use * Unable to attend sessions * Indications that participant is not appropriate for the study (e.g., aggressive, intoxicated, disruptive, visibly ill) * Does not self-identify as African American, Hispanic, or White (non-Hispanic)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants Reporting 7 Day Point Prevalence Abstinence | 12-months | Reported will be the number of participants reporting 7 day point prevalence of smoking abstinence |
| Change in Perceived Stress Scores | Baseline, 4 weeks | The Perceived Stress Scale (PSS) is a 10-item questionnaire with scores ranging from 0-40 with higher scores indicated greater stress. |
| Change in Depressive Symptoms Scores | Baseline, 4 weeks | Depressive scores based on Center for Epidemiologic Studies Depression Scale (CESD). CESD has a total score ranging from 0-60 with a higher score indicating greater depressive symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group Cognitive Behavioral Therapy Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].
Group Cognitive Behavioral Therapy: The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include a functional analysis of smoking patterns, environmental cues, and motivation for change, and cover nicotine addiction and withdrawal, health consequences, benefits of cessation, stress management, negative affect, alcohol use, triggers, coping responses, cognitive restructuring, social support, decision making, weight control, and physical activity.
Transdermal Nicotine Patch: Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations. | 165 |
| General Health Education Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].
General Health Education: The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include didactic information on tobacco-associated morbidities, such as heart disease, diabetes, and hypertension. Content may include Power Point-delivered lectures on the prevalence, etiology, basic pathology, symptom patterns, and treatment of the conditions, and discussion questions designed to facilitate learning and interest. Smoking cessation specific topics will not be addressed, and coping skills will not be provided. Participants will be allowed to share feelings regarding smoking (if they mention them) and general questions will be answered, although no specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere to the TNP protocol).
Transdermal Nicotine Patch: Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations. | 191 |
| Total | 356 |
Baseline characteristics
| Characteristic | General Health Education | Total | Group Cognitive Behavioral Therapy |
|---|---|---|---|
| Age, Continuous | 51.86 years STANDARD_DEVIATION 10.71 | 51.08 years STANDARD_DEVIATION 10.73 | 50.13 years STANDARD_DEVIATION 10.73 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 137 Participants | 184 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 168 Participants | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Black/African American | 81 Participants | 144 Participants | 63 Participants |
| Race/Ethnicity, Customized Native American | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 27 Participants | 51 Participants | 24 Participants |
| Race/Ethnicity, Customized White | 81 Participants | 159 Participants | 78 Participants |
| Sex/Gender, Customized Female | 97 Participants | 180 Participants | 83 Participants |
| Sex/Gender, Customized Male | 94 Participants | 175 Participants | 81 Participants |
| Sex/Gender, Customized Unknown | 0 Participants | 1 Participants | 1 Participants |
| Total Household Income $10,000-$20,000 | 36 participants | 72 participants | 36 participants |
| Total Household Income $20,001-$30,000 | 20 participants | 41 participants | 21 participants |
| Total Household Income $30,001-$40,000 | 10 participants | 25 participants | 15 participants |
| Total Household Income $40,001-$50,000 | 11 participants | 21 participants | 10 participants |
| Total Household Income $50,001-$60,000 | 13 participants | 21 participants | 10 participants |
| Total Household Income $60,001-$70,000 | 4 participants | 11 participants | 7 participants |
| Total Household Income $70,001-$80,000 | 3 participants | 5 participants | 2 participants |
| Total Household Income $80,001-$90,000 | 4 participants | 7 participants | 3 participants |
| Total Household Income Over $90,000 | 14 participants | 23 participants | 9 participants |
| Total Household Income Under $10,000 | 73 participants | 122 participants | 49 participants |
| Total Household Income Unknown | 3 participants | 6 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 165 | 4 / 191 |
| other Total, other adverse events | 2 / 165 | 0 / 191 |
| serious Total, serious adverse events | 0 / 165 | 4 / 191 |
Outcome results
Primary
Change in Depressive Symptoms Scores
Depressive scores based on Center for Epidemiologic Studies Depression Scale (CESD). CESD has a total score ranging from 0-60 with a higher score indicating greater depressive symptoms.
Time frame: Baseline, 4 weeks
Population: Not all participants that completed the 4 week follow up visit were able to complete the CESD questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Cognitive Behavioral Therapy | Change in Depressive Symptoms Scores | -1.84 score on a scale | Standard Error 0.841 |
| General Health Education | Change in Depressive Symptoms Scores | -1.53 score on a scale | Standard Error 0.803 |
Primary
Change in Perceived Stress Scores
The Perceived Stress Scale (PSS) is a 10-item questionnaire with scores ranging from 0-40 with higher scores indicated greater stress.
Time frame: Baseline, 4 weeks
Population: Not all participants that completed the 4 week follow up visit were able to complete the PSS questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Cognitive Behavioral Therapy | Change in Perceived Stress Scores | -1.47 score on a scale | Standard Error 0.502 |
| General Health Education | Change in Perceived Stress Scores | -1.85 score on a scale | Standard Error 0.534 |
Primary
The Number of Participants Reporting 7 Day Point Prevalence Abstinence
Reported will be the number of participants reporting 7 day point prevalence of smoking abstinence
Time frame: 12-months
Population: Not all participants that completed the 12 month follow up visit were able to report their 7 day point prevalence abstinence
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group Cognitive Behavioral Therapy | The Number of Participants Reporting 7 Day Point Prevalence Abstinence | 54 Participants |
| General Health Education | The Number of Participants Reporting 7 Day Point Prevalence Abstinence | 45 Participants |