Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention
Overview
- Phase
- Phase 4
- Intervention
- Group Cognitive Behavioral Therapy
- Conditions
- Smoking Cessation
- Sponsor
- University of Miami
- Enrollment
- 356
- Locations
- 2
- Primary Endpoint
- Change in Perceived Stress Scores
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
David Lee
Associate Professor
University of Miami
Eligibility Criteria
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)
Arms & Interventions
Group Cognitive Behavioral Therapy
Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].
Intervention: Group Cognitive Behavioral Therapy
Group Cognitive Behavioral Therapy
Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].
Intervention: Transdermal Nicotine Patch
General Health Education
Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].
Intervention: General Health Education
General Health Education
Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].
Intervention: Transdermal Nicotine Patch
Outcomes
Primary Outcomes
Change in Perceived Stress Scores
Time Frame: 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.
The Number of Participants Reporting 7 Day Point Prevalence Abstinence
Time Frame: 12-months
Reported will be the number of participants reporting 7 day point prevalence of smoking abstinence
Change in Depressive Symptoms Scores
Time Frame: 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.