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

September 24, 2019 updated by: Yvonne Olando, University of Nairobi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Mathari Treatment and Referral Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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:

  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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self reported continued tobacco use abstinence
Time Frame: Week 4, 12 and 26
The study's primary outcome was self-reported continuous tobacco use abstinence, biochemically verified.
Week 4, 12 and 26
Health related quality of life
Time Frame: Week 26
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
Time Frame: Week 4, 12 and 26
Secondary outcomes assessed included self reported quit attempts
Week 4, 12 and 26
Reduction in amounts used
Time Frame: Week 4, 12 and 26
Secondary outcome assessed included change in amount of cigarettes smoked or tobacco used, as reported by participants
Week 4, 12 and 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nairobi

Investigators

  • Principal Investigator: Yvonne Olando, University of Nairobi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2017

Primary Completion (Actual)

July 5, 2019

Study Completion (Actual)

August 9, 2019

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 5, 2019

First Posted (Actual)

July 10, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P641/09/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data sharing may be considered upon reasonable request

IPD Sharing Time Frame

The data will be available after analysis is complete. This should be in November 2019.

IPD Sharing Access Criteria

On request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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