Culturally Specific Interventions: African American Smokers

NCT ID: NCT01811758

Last Updated: 2015-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 345 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Culturally Specific CBT

Intervention Type: BEHAVIORAL

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.

Group Type: ACTIVE_COMPARATOR

Standard CBT

Intervention Type: BEHAVIORAL

Interventions

Culturally Specific CBT

Intervention Type: BEHAVIORAL

Standard CBT

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Monica W. Hooper

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monica Hooper, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Coral Gables, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25566367 (View on PubMed)

Other Identifiers

SmokeBreak2

Identifier Type: -

Identifier Source: org_study_id