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

Study Overview
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Brief Summary
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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
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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: 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 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.

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

Conditions
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Mental Illness

Intervention / Treatment
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* Behavioral: Group tobacco cessation interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants in the intervention group were introduced to a structured group tobacco cessation program. They met twice a month, for a period of 3 months, then were followed up once a month for a period of 3 months. Each meeting session lasted for a period of 45 minutes. They shared their feelings, and experiences with cessation attempt at the beginning of each session. The facilitator then documented their quit attempts, any changes in numbers of cigarettes smoked, and any challenges with cessation attempts noted. The facilitator then introduced the topic of the day and facilitated discussion on the same. Where skills practice was involved, the facilitator demonstrated to the participants how to apply the skill.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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 | Behavioral: Group tobacco cessation interventions<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported continued tobacco use abstinence | The study's primary outcome was self-reported continuous tobacco use abstinence, biochemically verified. | Week 4, 12 and 26 | 
| Health related quality of life | Secondary outcome assessed included changes in health related quality of life as assessed by WHOQOL | Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quit attempts | Secondary outcomes assessed included self reported quit attempts | Week 4, 12 and 26 | 
| Reduction in amounts used | Secondary outcome assessed included change in amount of cigarettes smoked or tobacco used, as reported by participants | Week 4, 12 and 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco cessation, mental illness, tobacco dependence, Kenya