Trial Outcomes & Findings for Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention (NCT NCT02511236)
NCT ID: NCT02511236
Last Updated: 2021-06-24
Results Overview
Reported will be the number of participants reporting 7 day point prevalence of smoking abstinence
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
356 participants
Primary outcome timeframe
12-months
Results posted on
2021-06-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
191
|
|
Overall Study
COMPLETED
|
125
|
146
|
|
Overall Study
NOT COMPLETED
|
40
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention
Baseline characteristics by cohort
| Measure |
Group Cognitive Behavioral Therapy
n=165 Participants
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.
|
General Health Education
n=191 Participants
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.
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.13 years
STANDARD_DEVIATION 10.73 • n=39 Participants
|
51.86 years
STANDARD_DEVIATION 10.71 • n=41 Participants
|
51.08 years
STANDARD_DEVIATION 10.73 • n=35 Participants
|
|
Sex/Gender, Customized
Female
|
83 Participants
n=39 Participants
|
97 Participants
n=41 Participants
|
180 Participants
n=35 Participants
|
|
Sex/Gender, Customized
Male
|
81 Participants
n=39 Participants
|
94 Participants
n=41 Participants
|
175 Participants
n=35 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=39 Participants
|
137 Participants
n=41 Participants
|
184 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=39 Participants
|
52 Participants
n=41 Participants
|
168 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
White
|
78 Participants
n=39 Participants
|
81 Participants
n=41 Participants
|
159 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
63 Participants
n=39 Participants
|
81 Participants
n=41 Participants
|
144 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race/Ethnicity, Customized
Other
|
24 Participants
n=39 Participants
|
27 Participants
n=41 Participants
|
51 Participants
n=35 Participants
|
|
Total Household Income
Under $10,000
|
49 participants
n=39 Participants
|
73 participants
n=41 Participants
|
122 participants
n=35 Participants
|
|
Total Household Income
$10,000-$20,000
|
36 participants
n=39 Participants
|
36 participants
n=41 Participants
|
72 participants
n=35 Participants
|
|
Total Household Income
$20,001-$30,000
|
21 participants
n=39 Participants
|
20 participants
n=41 Participants
|
41 participants
n=35 Participants
|
|
Total Household Income
$30,001-$40,000
|
15 participants
n=39 Participants
|
10 participants
n=41 Participants
|
25 participants
n=35 Participants
|
|
Total Household Income
$40,001-$50,000
|
10 participants
n=39 Participants
|
11 participants
n=41 Participants
|
21 participants
n=35 Participants
|
|
Total Household Income
$50,001-$60,000
|
10 participants
n=39 Participants
|
13 participants
n=41 Participants
|
21 participants
n=35 Participants
|
|
Total Household Income
$60,001-$70,000
|
7 participants
n=39 Participants
|
4 participants
n=41 Participants
|
11 participants
n=35 Participants
|
|
Total Household Income
$70,001-$80,000
|
2 participants
n=39 Participants
|
3 participants
n=41 Participants
|
5 participants
n=35 Participants
|
|
Total Household Income
$80,001-$90,000
|
3 participants
n=39 Participants
|
4 participants
n=41 Participants
|
7 participants
n=35 Participants
|
|
Total Household Income
Over $90,000
|
9 participants
n=39 Participants
|
14 participants
n=41 Participants
|
23 participants
n=35 Participants
|
|
Total Household Income
Unknown
|
3 participants
n=39 Participants
|
3 participants
n=41 Participants
|
6 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12-monthsPopulation: Not all participants that completed the 12 month follow up visit were able to report their 7 day point prevalence abstinence
Reported will be the number of participants reporting 7 day point prevalence of smoking abstinence
Outcome measures
| Measure |
Group Cognitive Behavioral Therapy
n=97 Participants
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.
|
General Health Education
n=113 Participants
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.
|
|---|---|---|
|
The Number of Participants Reporting 7 Day Point Prevalence Abstinence
|
54 Participants
|
45 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksPopulation: Not all participants that completed the 4 week follow up visit were able to complete the PSS questionnaire
The Perceived Stress Scale (PSS) is a 10-item questionnaire with scores ranging from 0-40 with higher scores indicated greater stress.
Outcome measures
| Measure |
Group Cognitive Behavioral Therapy
n=118 Participants
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.
|
General Health Education
n=139 Participants
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.
|
|---|---|---|
|
Change in Perceived Stress Scores
|
-1.47 score on a scale
Standard Error 0.502
|
-1.85 score on a scale
Standard Error 0.534
|
PRIMARY outcome
Timeframe: Baseline, 4 weeksPopulation: Not all participants that completed the 4 week follow up visit were able to complete the CESD questionnaire
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.
Outcome measures
| Measure |
Group Cognitive Behavioral Therapy
n=116 Participants
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.
|
General Health Education
n=140 Participants
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.
|
|---|---|---|
|
Change in Depressive Symptoms Scores
|
-1.84 score on a scale
Standard Error 0.841
|
-1.53 score on a scale
Standard Error 0.803
|
Adverse Events
Group Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
General Health Education
Serious events: 4 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Group Cognitive Behavioral Therapy
n=165 participants at risk
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.
|
General Health Education
n=191 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Death/Suicide
|
0.00%
0/165 • 12 months
|
0.52%
1/191 • Number of events 1 • 12 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/165 • 12 months
|
0.52%
1/191 • Number of events 1 • 12 months
|
|
Immune system disorders
Death
|
0.00%
0/165 • 12 months
|
0.52%
1/191 • Number of events 1 • 12 months
|
|
Cardiac disorders
Death
|
0.00%
0/165 • 12 months
|
0.52%
1/191 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Group Cognitive Behavioral Therapy
n=165 participants at risk
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.
|
General Health Education
n=191 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Achillese tendon injury
|
0.61%
1/165 • Number of events 1 • 12 months
|
0.00%
0/191 • 12 months
|
|
Psychiatric disorders
Suicidal ideation
|
0.61%
1/165 • Number of events 1 • 12 months
|
0.00%
0/191 • 12 months
|
Additional Information
David J. Lee
University of Miami Miller School of Medicine
Phone: 305-243-9680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place