Clinical Trial Details

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Study ID 20150356
Investigator
Monica W Hooper, PhD,   University of Miami
Title Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention
Conditions Smoking Cessation
Interventions Behavioral: Group Cognitive Behavioral Therapy
Behavioral: General Health Education
Drug: Transdermal Nicotine Patch
Phase N/A
Purpose The importance of reducing tobacco-associated health disparities between cannot be understated. Racial/ethnic minorities are less likely to quit, and tend to have elevated stress and depressive symptoms, which may contribute to cessation disparities. Cognitive behavioral therapy (CBT) for cessation addresses these concerns and has the potential to reduce/eliminate disparities. Preliminary research found racial/ethnic differences in baseline perceived stress and depressive symptoms. Following CBT, these differences were no longer present. Moreover, compared to Whites, African Americans exhibited blunted hypothalamic-pituitary-adrenal (HPA) axis functioning. This randomized controlled trial (RCT) will be the first to test the impact of CBT on smoking cessation disparities. The specific aims are to: (1) Examine the effects of CBT on perceived stress and depressive symptoms in a racially/ethnically diverse sample; (2) test the efficacy of CBT for eliminating smoking cessation disparities; and (3) examine physiological distress as an underlying mechanism for the effects of CBT on racial/ethnic minority smokers (exploratory). It is hypothesized that CBT will eliminate racial/ethnic differences in distress symptoms compared to the general health education (GHE) control group. A condition and race/ethnicity interaction on 7-day point prevalence abstinence (ppa) is also expected, with no racial/ethnic differences in cessation in the CBT condition only. It is also hypothesized that HPA functioning will mediate the effect of CBT on smoking cessation, particularly among racial/ethnic minorities. This study has implications for eliminating disparities in psychosocial factors related to cessation, and disparities in success. Addressing stress and depressive symptoms through CBT may facilitate cessation, particularly among racial/ethnic minorities.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Both
Accepts Healthy Volunteers:  Accepts Healthy Volunteers
Inclusion Criteria:
  • Self-identify as African American/Black, Hispanic (any race), or White non-Hispanic
  • Smoke at least 5 cigarettes/day or carbon monoxide (CO) reading of at least 8 ppm
  • be over age 18
  • speak/read English Exclusion Criteria:
  • Contraindications for transdermal nicotine patch therapy (TNP)
  • Cognitive or mental health impairment that inhibits group treatment
  • Currently being treated for smoking cessation, alcoholism, or illicit drug use
  • Unable to attend sessions
  • Indications that participant is not appropriate for the study (e.g., aggressive, intoxicated, disruptive, visibly ill)
  • Does not self-identify as African American, Hispanic, or White (non-Hispanic)
  • Study Location N/A
    Contact Monica W Hooper, PhD
    305-284-4280
    mwebb@miami.edu
    Information obtained from ClinicalTrials.gov, on 7/29/2015. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT02511236


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