Culturally Specific Interventions: African American Smokers

NCT01811758 | Completed Phase 1

• 1 other identifier: SmokeBreak2
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Smoking Cessation

Keywords

Culturally Specific Cognitive Behavioral Therapy; Standard Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 7-day point prevalence abstinence

  Generalized linear mixed model of overall intervention effect.

  Overall effect at 12-months

Secondary Outcomes (1)

• 7-day point prevalence abstinence

  6-months

Study Arms (2)

Culturally Specific CBT

EXPERIMENTAL

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

Standard CBT (control)

ACTIVE COMPARATOR

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

Interventions

Culturally Specific CBT BEHAVIORAL

Culturally Specific CBT

Standard CBT BEHAVIORAL

Standard CBT (control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• University of Minnesota: collaborator

Study Sites (1)

University of Miami

Coral Gables, Florida, 33124, United States

Location

Related Publications (1)

• Hooper MW, Larry R, Okuyemi K, Resnicow K, Dietz NA, Robinson RG, Antoni MH. Culturally specific versus standard group cognitive behavioral therapy for smoking cessation among African Americans: an RCT protocol. BMC Psychol. 2013 Aug 21;1(1):15. doi: 10.1186/2050-7283-1-15. eCollection 2013.

  PMID: 25566367 BACKGROUND

MeSH Terms

Conditions

Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Monica Hooper, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 15, 2013
• Study Start: August 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: April 1, 2014
• Last Updated: July 10, 2015

Record last verified: 2015-07

Locations

US (1)