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

Yvonne Olando,Mary Kuria,Mark D Huffman,Muthoni Mathai

doi:10.1186/s12889-019-8040-2

Abstract

BackgroundThe 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/designOne 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.DiscussionThis 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 registrationTrial registration number: NCT04013724.Name of registry: ClinicalTrials.gov.URL of registry: https://register.clinicaltrials.govDate of registration: 9 July 2019 (retrospectively registered).Date of enrolment of the first participant to the trial: 5th September 2017.Protocol version: 2.0.

Highlights

The rate of tobacco use among people with mental illness is nearly twice that of the general population
Patients with serious mental disorders have a greater prevalence of tobacco use [3], more severe psychiatric symptoms, poorer overall general well-being, and greater functional impairment when compared to non-tobacco users [4]
World Health Organization (WHO) recognizes 5 domains that should be captured while assessing quality of life: Physical, Psychological, social, environmental, and spiritual [9]

Summary

Introduction

The rate of tobacco use among people with mental illness is nearly twice that of the general population. Patients with serious mental disorders have a greater prevalence of tobacco use [3], more severe psychiatric symptoms, poorer overall general well-being, and greater functional impairment when compared to non-tobacco users [4]. According to World Health Organization (WHO), Quality of Life (QOL) definition is individualistic, has a cultural and value systems dimension in relation to the persons goals, expectations, standards and concerns. WHO recognizes 5 domains that should be captured while assessing quality of life: Physical, Psychological, social, environmental, and spiritual [9]. With the rate at which a person with mental illness smokes, they are more likely to suffer from the physical domain, due to the health impact of tobacco use. Most people with mental illness need support to balance their emotional and physical needs

Objectives

Methods

Findings

Conclusion