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

Sponsor
University of Nairobi (Other)
Overall Status
Completed
CT.gov ID
NCT04013724
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
28
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Group tobacco cessation interventions
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Efficacy of a Group Tobacco Cessation Behavioral Intervention Among Tobacco Users With Concomitant Mental Illness in Kenya: Protocol for a Controlled Clinical Trial
Actual Study Start Date :
Apr 10, 2017
Actual Primary Completion Date :
Jul 5, 2019
Actual Study Completion Date :
Aug 9, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. Self reported continued tobacco use abstinence [Week 4, 12 and 26]

    The study's primary outcome was self-reported continuous tobacco use abstinence, biochemically verified.

  2. Health related quality of life [Week 26]

    Secondary outcome assessed included changes in health related quality of life as assessed by WHOQOL

Secondary Outcome Measures

  1. Quit attempts [Week 4, 12 and 26]

    Secondary outcomes assessed included self reported quit attempts

  2. Reduction in amounts used [Week 4, 12 and 26]

    Secondary outcome assessed included change in amount of cigarettes smoked or tobacco used, as reported by participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. 18 years of age and above.

  2. History of tobacco use for more than 6 months.

  3. A Fagerstrom score of 6 and above, which is a threshold consistent with dependence.16

  4. Currently on outpatient follow up treatment for a diagnosed mental health condition.

  5. Willing to be part of the study for 6 months.

Exclusion Criteria:

  1. Patients on nicotine replacement therapy (NRT) or other pharmacotherapy for tobacco cessation.

  2. Patients currently experiencing severe psychotic episodes judged by their treating health care provider.

  3. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mathari Treatment and Referral Hospital Nairobi Kenya

Sponsors and Collaborators

  • University of Nairobi

Investigators

  • Principal Investigator: Yvonne Olando, University of Nairobi

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yvonne Olando, Clinical Psychologist, University of Nairobi
ClinicalTrials.gov Identifier:
NCT04013724
Other Study ID Numbers:
  • P641/09/2016
First Posted:
Jul 10, 2019
Last Update Posted:
Sep 25, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yvonne Olando, Clinical Psychologist, University of Nairobi
Tobacco cessation, mental illness, tobacco dependence, Kenya
Additional relevant MeSH terms:
Mental Disorders

Study Results

No Results Posted as of Sep 25, 2019