Culturally Specific Interventions: African American Smokers

Study Overview
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Brief Summary
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The investigators expect that a culturally specific group intervention targeting African American smokers will result in greater smoking cessation rates compared to a standard intervention.

Official Title
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Culturally Specific Interventions and Acculturation in African American Smokers

Conditions
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Smoking, Smoking Cessation

Intervention / Treatment
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* Behavioral: Culturally Specific CBT
* Behavioral: Standard CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: self-identification as African American current smoker of ≥ 5 cigarettes/day or expired CO level of ≥ 8 ppm; age 18-65; able to speak and read English; permanent contact information; access to transportation by public transit or car; no current behavioral or pharmacological treatment ; interest in quitting smoking; (9) have availability to attend sessions. Exclusion Criteria: enrolled in another cessation program, do not speak and read English, do not have access to transportation by car or bus to attend sessions, do not have childcare during session times, have contraindications for patch use (pregnant/breastfeeding), if they are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse), if they endorse active addiction to another substance (e.g., illicit drugs or alcohol), if they have been diagnosed with an acute cardiac or respiratory condition; people identified as having a severe mental illness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally Specific CBT<br>Culturally specific cognitive behavioral therapy. Group format, 8 sessions, approximately 90 minutes. Up to 8-weeks of transdermal nicotine patches. Focused on African Americans: smoking patterns, health outcomes, discrimination, stress, weight concerns, cultural beliefs and practices. | Behavioral: Culturally Specific CBT<br> <br> |
| Active Comparator: Standard CBT (control)<br>Standard cognitive behavioral therapy. Group format, 8 sessions, approximately 90 minutes each. Up to 8-weeks of transdermal nicotine patches. Traditional CBT, with no focus on race: smoking and health, benefits of quitting, weight control, relapse prevention, coping skills. | Behavioral: Standard CBT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence abstinence | Generalized linear mixed model of overall intervention effect. | Overall effect at 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence abstinence |  | 6-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Culturally Specific Cognitive Behavioral Therapy, Standard Cognitive Behavioral Therapy