Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention
1 other identifier
interventional
356
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2015
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2019
CompletedResults Posted
Study results publicly available
June 24, 2021
CompletedJune 24, 2021
June 1, 2021
4.2 years
July 24, 2015
June 1, 2021
June 1, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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
12-months
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.
Baseline, 4 weeks
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.
Baseline, 4 weeks
Study Arms (2)
Group Cognitive Behavioral Therapy
EXPERIMENTALParticipants 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
ACTIVE COMPARATORParticipants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) \[21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)\].
Interventions
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.
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Miami
Coral Gables, Florida, 33124, United States
H Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Related Publications (2)
Webb Hooper M, Lee DJ, Simmons VN, Brandon KO, Antoni MH, Asfar T, Koru-Sengul T, Brandon TH. Cognitive behavioral therapy versus general health education for smoking cessation: A randomized controlled trial among diverse treatment seekers. Psychol Addict Behav. 2024 Feb;38(1):124-133. doi: 10.1037/adb0000928. Epub 2023 May 4.
PMID: 37141036DERIVEDWebb Hooper M, Lee DJ, Simmons VN, Brandon KO, Antoni MH, Unrod M, Asfar T, Correa JB, Koru-Sengul T, Brandon TH. Reducing racial/ethnic tobacco cessation disparities via cognitive behavioral therapy: Design of a dualsite randomized controlled trial. Contemp Clin Trials. 2018 May;68:127-132. doi: 10.1016/j.cct.2018.03.017. Epub 2018 Apr 1.
PMID: 29617633DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David J. Lee
- Organization
- University of Miami Miller School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
David Lee, PhD
University of Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 24, 2015
First Posted
July 29, 2015
Study Start
August 1, 2015
Primary Completion
October 23, 2019
Study Completion
October 23, 2019
Last Updated
June 24, 2021
Results First Posted
June 24, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share