Efficacy of a group tobacco cessation behavioral intervention among tobacco users with concomitant mental illness in Kenya: protocol for a controlled clinical trial

BACKGROUND: The rate of tobacco use among people with mental illness is nearly twice that of the general population. Psychotropic medications for tobacco cessation are relatively expensive for most Kenyans. Behavioral counseling and group therapy are effective lower cost strategies to promote tobacco cessation, yet have not been studied in Kenya among individuals with concomitant mental illness. METHODS/DESIGN: One hundred tobacco users with mental illness who were part of an outpatient mental health program in Nairobi, Kenya were recruited and allocated into intervention and control groups of the study (50 users in intervention group and 50 users in control group). Participants allocated to the intervention group were invited to participate in 1 of 5 tobacco cessation groups. The intervention group received the 5As (Ask, Advise, Assess, Assist and Arrange) and tobacco cessation group behavioral intervention, which included strategies to manage cravings and withdrawal, stress and anxiety, and coping with depression due to withdrawal; assertiveness training and anger management; reasons to quit, benefits of quitting and different ways of quitting. Individuals allocated to the control group received usual care. The primary outcome was tobacco cessation at 24 weeks, measured through cotinine strips. Secondary outcomes included number of quit attempts and health-related quality of life. DISCUSSION: This study will provide evidence to evaluate the efficacy and safety of a tobacco cessation group behavioral intervention among individuals with mental illness in Kenya, and to inform national and regional practice and policy. TRIAL REGISTRATION: Trial registration number: NCT04013724. Name of registry: ClinicalTrials.gov. URL of registry: https://register.clinicaltrials.gov Date of registration: 9 July 2019 (retrospectively registered). Date of enrolment of the first participant to the trial: 5th September 2017. Protocol version: 2.0.