University of Nairobi, Nairobi, Kenya.
Northwestern University Feinberg School of Medicine, Chicago, USA.
BMC Public Health. 2019 Dec 18;19(1):1700. doi: 10.1186/s12889-019-8040-2.
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.
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 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.
精神疾病患者的吸烟率几乎是普通人群的两倍。对于大多数肯尼亚人来说，用于戒烟的精神药物相对昂贵。行为咨询和团体治疗是促进戒烟的更具成本效益的策略，但在肯尼亚，针对同时患有精神疾病的个体，尚未对此进行研究。
方法/设计：在肯尼亚内罗毕的一个门诊心理健康计划中，招募了 100 名患有精神疾病的烟草使用者，并将他们分配到干预组和对照组（干预组 50 名使用者，对照组 50 名使用者）。分配到干预组的参与者被邀请参加 5 个戒烟小组中的 1 个。干预组接受了 5A（询问、建议、评估、协助和安排）和戒烟小组行为干预，其中包括管理烟瘾和戒断症状、压力和焦虑以及应对戒断引起的抑郁的策略；自信训练和愤怒管理；戒烟的原因、戒烟的好处和不同的戒烟方式。分配到对照组的个体接受常规护理。主要结局是 24 周时的戒烟情况，通过可替宁检测条进行测量。次要结局包括戒烟尝试次数和健康相关生活质量。
本研究将提供证据，评估肯尼亚精神疾病患者中戒烟小组行为干预的疗效和安全性，并为国家和区域实践和政策提供信息。
试验注册号：NCT04013724。注册机构名称：ClinicalTrials.gov。注册网址：https://register.clinicaltrials.gov。注册日期：2019 年 7 月 9 日（回溯注册）。试验中第一个参与者入组日期：2017 年 9 月 5 日。方案版本：2.0。
