Culturally Specific Interventions: African American Smokers (SB2)
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|ClinicalTrials.gov Identifier: NCT01811758|
Recruitment Status : Completed
First Posted : March 15, 2013
Last Update Posted : July 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Smoking Smoking Cessation||Behavioral: Culturally Specific CBT Behavioral: Standard CBT||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||345 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Culturally Specific Interventions and Acculturation in African American Smokers|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||April 2014|
Experimental: 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.
Behavioral: Culturally Specific CBT
Active Comparator: Standard CBT (control)
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
- 7-day point prevalence abstinence [ Time Frame: Overall effect at 12-months ]Generalized linear mixed model of overall intervention effect.
- 7-day point prevalence abstinence [ Time Frame: 6-months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811758
|United States, Florida|
|University of Miami|
|Coral Gables, Florida, United States, 33124|
|Principal Investigator:||Monica Hooper, PhD||University of Miami|