Culturally Specific Interventions: African American Smokers

Phase 1

Completed

• Conditions: Smoking; Smoking Cessation
• Interventions: Behavioral: Culturally Specific CBT; Behavioral: Standard CBT

• Registration Number: NCT01811758
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-14
• Study First Posted: 2013-03-15
• Primary Completion: 2013-09
• Study Completion: 2014-04
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

1. self-identification as African American
2. current smoker of ≥ 5 cigarettes/day or expired CO level of ≥ 8 ppm;
3. age 18-65;
4. able to speak and read English;
5. permanent contact information;
6. access to transportation by public transit or car;
7. no current behavioral or pharmacological treatment ;
8. interest in quitting smoking; (9) have availability to attend sessions.

Exclusion Criteria

1. enrolled in another cessation program,
2. do not speak and read English,
3. do not have access to transportation by car or bus to attend sessions,
4. do not have childcare during session times,
5. have contraindications for patch use (pregnant/breastfeeding),
6. if they are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse),
7. if they endorse active addiction to another substance (e.g., illicit drugs or alcohol),
8. if they have been diagnosed with an acute cardiac or respiratory condition;
9. people identified as having a severe mental illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Culturally Specific CBT	Culturally Specific CBT	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.
Standard CBT (control)	Standard CBT	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.

Primary Outcome Measures

Name	Time	Method
7-day point prevalence abstinence	Overall effect at 12-months	Generalized linear mixed model of overall intervention effect.

Secondary Outcome Measures

Name	Time	Method
7-day point prevalence abstinence	6-months

Trial Locations

Locations (1)

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