Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention

Phase 4

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: General Health Education; Behavioral: Group Cognitive Behavioral Therapy; Drug: Transdermal Nicotine Patch

• Registration Number: NCT02511236
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-07-24
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-29
• Study Start: 2015-08
• Primary Completion: 2019-10-23
• Study Completion: 2019-10-23
• Disposition First Submitted: 2020-10-01
• Disposition First Submitted QC: 2020-10-01
• Disposition First Posted: 2020-10-12
• Status Verified: 2021-06
• Results First Submitted: 2021-06-01
• Results First Submitted QC: 2021-06-01
• Last Update Submitted: 2021-06-01
• Results First Posted: 2021-06-24
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Cognitive Behavioral Therapy	Transdermal Nicotine Patch	Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].
General Health Education	Transdermal Nicotine Patch	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	General Health Education	Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].
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) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].

Primary Outcome Measures

Name	Time	Method
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.
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 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.

Trial Locations

Locations (2)

University of Miami; 🇺🇸 Coral Gables, Florida, United States

H Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States