Webb Hooper 2018.
| Study name | Addressing racial/ethnic tobacco health disparities via group intervention |
| Methods | A 2‐arm, dual‐site, parallel‐group, randomised controlled trial aimed at evaluating the efficacy of group CBT in eliminating racial/ethnic differences in smoking cessation and distress. Blinding/masking: none (open‐label); 2 (group intervention) x 3 (race/ethnicity) design. Participants not informed of study condition ‐ informed they will receive a supportive group‐based cessation intervention combined with NRT |
| Participants | General population: adults who smoke (18+ years) that self‐identify as African American/Black, Hispanic (any race), or non‐Hispanic White and report smoking at least 5 cigarettes per day |
| Interventions | Experimental: Group Cognitive Behavioural Therapy ‐ participants may receive 8 group cognitive behavioural therapy (CBT) sessions and 8 weeks of transdermal nicotine patches (TNP) (21 mg (4 weeks), 14 mg (2 weeks), and 7 mg (2 weeks)). Active Comparator: General Health Education: Participants may receive group general health education (GHE) sessions and 8 weeks of transdermal nicotine patches (TNP) (21 mg (4 weeks), 14 mg (2 weeks), and 7 mg (2 weeks)) |
| Outcomes | Primary outcome(s): biochemically‐confirmed 7‐day point‐prevalence abstinence (ppa), which will be assessed over a 12‐month follow‐up period, and change in perceived distress and depressive symptoms pre‐ to post‐intervention. The mediating role of physiological distress is considered exploratory. Other outcome measures: Change in salivary cortisol level (Time Frame: 12‐months) |
| Starting date | Study start date: August 2015; actual study completion date: October 23, 2019 |
| Contact information | Corresponding author at: Case Comprehensive Cancer Center, Case Western Reserve University School of Medicine, 10900 Euclid Ave, Cleveland, OH 44106‐7285, USA. E‐mail address: monica.hooper@case.edu (M. Webb Hooper) |
| Notes | Registry ID: Clinicaltrials.gov NCT02511236 Funding source: The Florida Department of Health, James and Esther King Biomedical Research Program funding study (5JK01) Declaration of interests: None specified |