Efficacy of a Group Tobacco Cessation Behavioral Intervention Among Tobacco Users With Concomitant Mental Illness in Kenya: Protocol for a Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Health related quality of life
研究概览
简要总结
The study seeks to provide group tobacco cessation interventions among patients who use tobacco, and who attend Mathari National referral hospital on outpatient follow up. They will also be assessed on changes in quality of life before and after provision of the intervention.
详细描述
All patients who walked in for follow-up after hospital discharge for a primary mental health diagnosis were informed of the study and were invited to participate. Informed consent was obtained from individuals who had capacity to provide informed consent in the presence of the clinicians working with the participants to ensure they understood the study requirements. Individuals who did not have capacity to provide informed consent were not recruited to minimize potential risks to this vulnerable population. After providing informed consent, participants were asked to complete the Fagerstrom tobacco use test. Participants were then asked to complete sociodemographic questionnaire and the World Health Organization (WHO) quality of life questionnaire. This screening and recruitment continued until the number of participants who provided informed consent reached 100.
Randomization/Allocation Participants were recruited in clusters of 10 for allocation into the intervention and control groups. The first 10 participants formed group 1, and the next 10 participants formed group 2. Group 1 became the first intervention group, while group 2 became the first control group. This procedure continued until all 10 groups were formed (5 intervention and 5 control groups).
Participants were followed up clinically for ongoing mental health care on their regular clinic days.
Study intervention 5As-based brief advice was offered to the intervention group participants by the study team who were trained by YO. This brief advice consisted of an individual session lasting approximately 5 minutes for each participant immediately after their consent had been obtained. The focus of the 5As was to enable the therapist know the immediate concern of each participant and to enable adequate support when the particular issues were raised during the group intervention sessions. The behavioral group intervention consisted of 6 sessions over 12 weeks and were led by 2 trained facilitators, followed by monthly group meetings from weeks 14 to 26. This program was adapted from the Royal Australian College of General Practitioners' Supporting Smoking Cessation Guide for Health Professionals17 and the World Health Organization's Strengthening Health Systems for Treating Tobacco Dependence in Primary Care training package.18
The topics that were explored during the group sessions include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
At the group assessments (Weeks 4, 12, and 26), participants who reported continued tobacco use abstinence and consented to a saliva test were tested using a nicotine cotinine strip (Devon Medical: Nicotine/tobacco test kit). The saliva tests were evaluated by the nurses working at the hospital who were blinded to treatment allocation and were not otherwise part of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age and above.
- •History of tobacco use for more than 6 months.
- •A Fagerstrom score of 6 and above, which is a threshold consistent with dependence.16
- •Currently on outpatient follow up treatment for a diagnosed mental health condition.
- •Willing to be part of the study for 6 months.
排除标准
- •Patients on nicotine replacement therapy (NRT) or other pharmacotherapy for tobacco cessation.
- •Patients currently experiencing severe psychotic episodes judged by their treating health care provider.
- •Patients who would not be able to commit to the group sessions, defined as those who would not be able to attend group sessions for any reason, including transport-related reasons.
研究组 & 干预措施
Intervention group
The behavioral group intervention consisted of 6 sessions over 12 weeks and were led by 2 trained facilitators, followed by monthly group meetings from weeks 14 to 26. This program was adapted from the Royal Australian College of General Practitioners' Supporting Smoking Cessation Guide for Health Professionals17 and the World Health Organization's Strengthening Health Systems for Treating Tobacco Dependence in Primary Care training package.18
The topics that were explored during the group sessions include:
- Introduction to the Program and Reasons to Quit
- Benefits of Quitting and Understanding Why We Smoke and Ways of Quitting
- Withdrawal Symptoms and Social Support
- Dealing with Stress and Anxiety and Coping with Depression
- Assertiveness Training and Anger Management
- Tobacco-Free Lifestyle and Dealing with High Risk Situations
干预措施: Group tobacco cessation interventions (Behavioral)
Control
The control group was provided questionnaires to fill at the end of Weeks 4, 12, and 26. During the rest of the study, they continued receiving usual care, including clinical care at CSAT.
结局指标
主要结局
Health related quality of life
时间窗: Week 26
Secondary outcome assessed included changes in health related quality of life as assessed by WHOQOL
Self reported continued tobacco use abstinence
时间窗: Week 4, 12 and 26
The study's primary outcome was self-reported continuous tobacco use abstinence, biochemically verified.
次要结局
- Quit attempts(Week 4, 12 and 26)
- Reduction in amounts used(Week 4, 12 and 26)
研究者
Yvonne Olando
Clinical Psychologist
University of Nairobi