NCT04013724

Efficacy of Group Tobacco Cessation Interventions Among Tobacco Users With Mental Illness: Controlled Clinical Trial

Efficacy of a Group Tobacco Cessation Behavioral Intervention Among Tobacco Users With Concomitant Mental Illness in Kenya: Protocol for a Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Nairobi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: 1. Introduction to the Program and Reasons to Quit 2. Benefits of Quitting and Understanding Why We Smoke and Ways of Quitting 3. Withdrawal Symptoms and Social Support 4. Dealing with Stress and Anxiety and Coping with Depression 5. Assertiveness Training and Anger Management 6. Tobacco-Free Lifestyle and Dealing with High Risk Situations Group Session 1 (Week 1) On the first session, participants were introduced to the study program and specific components of the group behavioral intervention. Participants shared their expectations and experiences in their goal of tobacco cessation. The estimated time for group session 1 was 30-45 minutes. Group Sessions 2-6 (Weeks 2-11) Participants set their anticipated quit date on the 2nd week, which was their second session. During weeks 2 through 11, before the start of the session, feelings of participants were explored, the previous week's self-reported tobacco consumption or cessation attempt was recorded. The topic of each week was explored first by lecture to explain the topic, and then group members took turns sharing their experiences on the topic. Group Sessions 7-9 (Weeks 14-26) Participants continued attending the CSAT outpatient and ward follow-up programs during this period. Behavioral group sessions 7-9 (weeks 14-26) were conducted once a month by the facilitators whereby each session was begun with a round of discussion on how participants were feeling about their cessation attempts, including any challenges they had experienced. The self-reported amount of tobacco used and quit attempts were documented. The study team also documented the challenges raised and tried to offer practical and supportive therapy for the challenges.

Conditions

• Mental Illness

Interventions

Type	Name	Description
BEHAVIORAL	Group tobacco cessation interventions	Group Session Week 1 Participants were introduced to the specific components of the group behavioral intervention. Participants shared their expectations and experiences in their goal of tobacco cessation. Group Sessions Weeks 2-11 Participants set their anticipated quit date on the 2nd week. During weeks 2 through 11, before the start of the session, feelings of participants were explored, the previous week's self-reported tobacco consumption or cessation attempt was recorded. The topic of each week was explored first by lecture to explain the topic, and then group members took turns sharing their experiences on the topic. Group Sessions Weeks 14-26 Behavioral group sessions weeks 14-26 were conducted once a month. Each session began with a round of discussion on how participants were feeling about their cessation attempts, including any challenges they had experienced. The self-reported amount of tobacco used and quit attempts were documented.

Timeline

• Start date: 2017-04-10
• Primary completion: 2019-07-05
• Completion: 2019-08-09
• First posted: 2019-07-10
• Last updated: 2019-09-25

Locations

1 site across 1 country: Kenya