Mental IllnessNCT04013724
Efficacy of Group Tobacco Cessation Interventions Among Tobacco Users With Mental Illness: Controlled Clinical Trial
A study testing Group tobacco cessation interventions in people with Mental Illness, run by University of Nairobi at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Illness
- What is being tested?
- Group tobacco cessation interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKenya
- Study dates
- 10 Apr 2017to 9 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Mental Illness
- Being tested
- Group tobacco cessation interventions
- Keywords
- Tobacco cessation, mental illness, tobacco dependence, Kenya
- Medical subject headings
- Mental Disorders, Tobacco Use Cessation, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group tobacco cessation interventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Behavioral: Group tobacco cessation interventions |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Self reported continued tobacco use abstinence
The study's primary outcome was self-reported continuous tobacco use abstinence, biochemically verified.
Measured: 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
Measured: Week 26
Secondary outcomes (2)
Quit attempts
Secondary outcomes assessed included self reported quit attempts
Measured: 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
Measured: Week 4, 12 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start10 Apr 2017
- Primary completion5 Jul 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nairobi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvonne Olando, University of Nairobi
- Investigators
- Yvonne Olando, Principal investigator, University of Nairobi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013724
- Sponsor's protocol ID
- P641/09/2016
- Status last verified
- Sep 2019
- First submitted
- 2 Jul 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing may be considered upon reasonable request
Publications
World Health Organization. International Classification of Diseases (ICD-10) and Health Problems. Geneva, Switzerland. 2015
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (Fifth version). Arlington, VA: American Psychiatric Association. 2013
Action on Smoking and Health (ASH) Fact sheet. Smoking and Mental Health. 2016. Available at: http://ash.org.uk/category/information-and-resources/fact-sheets/. Accessed 15 May 2019.
Heiligenstein E, Smith SS. Smoking and mental health problems in treatment-seeking university students. Nicotine Tob Res. 2006 Aug;8(4):519-23. doi: 10.1080/14622200600789718.
PubMed 16920649Brown C. Tobacco and Mental Health: A review of the literature. Edinburgh: ASH Scotland. 2004
Royal College of Psychiatrists. Liaison Psychiatry for acute hospital: Integrated mental and physical healthcare. London: College Report, Royal College of Psychiatrists. 2013
John U, Meyer C, Rumpf HJ, Hapke U. Smoking, nicotine dependence and psychiatric comorbidity--a population-based study including smoking cessation after three years. Drug Alcohol Depend. 2004 Dec 7;76(3):287-95. doi: 10.1016/j.drugalcdep.2004.06.004.
PubMed 15561479Weir, K. Smoking and mental illness. American Psychological Association Science Watch. 2013; 44 (6): 36.
Hall SM, Prochaska JJ. Treatment of smokers with co-occurring disorders: emphasis on integration in mental health and addiction treatment settings. Annu Rev Clin Psychol. 2009;5:409-31. doi: 10.1146/annurev.clinpsy.032408.153614.
PubMed 19327035Cavazos-Rehg PA, Breslau N, Hatsukami D, Krauss MJ, Spitznagel EL, Grucza RA, Salyer P, Hartz SM, Bierut LJ. Smoking cessation is associated with lower rates of mood/anxiety and alcohol use disorders. Psychol Med. 2014 Sep;44(12):2523-35. doi: 10.1017/S0033291713003206.
PubMed 25055171Prochaska JJ, Delucchi K, Hall SM. A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery. J Consult Clin Psychol. 2004 Dec;72(6):1144-56. doi: 10.1037/0022-006X.72.6.1144.
PubMed 15612860Gulliver SB, Wolfsdorf BA, Morissette SB. Treating tobacco dependence: Development of a smoking cessation treatment program for outpatient mental health clinics. Cogn Behav Pract. 2004; 11, 315-330
Morris CD, Tedeschi GJ, Waxmonsky JA, May M, Giese AA. Tobacco quitlines and persons with mental illnesses: perspective, practice, and direction. J Am Psychiatr Nurses Assoc. 2009 Feb;15(1):32-40. doi: 10.1177/1078390308330050.
PubMed 21665792Tsoi DT, Porwal M, Webster AC. Interventions for smoking cessation and reduction in individuals with schizophrenia. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD007253. doi: 10.1002/14651858.CD007253.pub3.
PubMed 23450574Bron C, Zullino D, Besson J, Borgeat F. [Smoking in psychiatry, a neglected problem]. Praxis (Bern 1994). 2000 Oct 19;89(42):1695-9. French.
PubMed 11105610
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04013724
- Acronym / sponsor ID
- P641/09/2016
- Conditions
- Mental Illness
- Keywords
- Tobacco cessation, mental illness, tobacco dependence, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of NairobiUniversity, hospital or other
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Group tobacco cessation interventionsThe 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 |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group tobacco cessation interventionsGroup 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. | Behavioural | Intervention group |
Primary outcome
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.
Health related quality of life
Time frame: Week 26
Secondary outcome assessed included changes in health related quality of life as assessed by WHOQOL
2 secondary outcomes
Quit attempts
Time frame: Week 4, 12 and 26
Reduction in amounts used
Time frame: Week 4, 12 and 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- BackgroundWorld Health Organization. International Classification of Diseases (ICD-10) and Health Problems. Geneva, Switzerland. 2015
- BackgroundAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (Fifth version). Arlington, VA: American Psychiatric Association. 2013
- BackgroundAction on Smoking and Health (ASH) Fact sheet. Smoking and Mental Health. 2016. Available at: http://ash.org.uk/category/information-and-resources/fact-sheets/. Accessed 15 May 2019.
- Background: PubMed 16920649Heiligenstein E, Smith SS. Smoking and mental health problems in treatment-seeking university students. Nicotine Tob Res. 2006 Aug;8(4):519-23. doi: 10.1080/14622200600789718.
- BackgroundBrown C. Tobacco and Mental Health: A review of the literature. Edinburgh: ASH Scotland. 2004
- BackgroundRoyal College of Psychiatrists. Liaison Psychiatry for acute hospital: Integrated mental and physical healthcare. London: College Report, Royal College of Psychiatrists. 2013
- Background: PubMed 15561479John U, Meyer C, Rumpf HJ, Hapke U. Smoking, nicotine dependence and psychiatric comorbidity--a population-based study including smoking cessation after three years. Drug Alcohol Depend. 2004 Dec 7;76(3):287-95. doi: 10.1016/j.drugalcdep.2004.06.004.
- BackgroundWeir, K. Smoking and mental illness. American Psychological Association Science Watch. 2013; 44 (6): 36.
- Background: PubMed 19327035Hall SM, Prochaska JJ. Treatment of smokers with co-occurring disorders: emphasis on integration in mental health and addiction treatment settings. Annu Rev Clin Psychol. 2009;5:409-31. doi: 10.1146/annurev.clinpsy.032408.153614.
- Background: PubMed 25055171Cavazos-Rehg PA, Breslau N, Hatsukami D, Krauss MJ, Spitznagel EL, Grucza RA, Salyer P, Hartz SM, Bierut LJ. Smoking cessation is associated with lower rates of mood/anxiety and alcohol use disorders. Psychol Med. 2014 Sep;44(12):2523-35. doi: 10.1017/S0033291713003206.
- Background: PubMed 15612860Prochaska JJ, Delucchi K, Hall SM. A meta-analysis of smoking cessation interventions with individuals in substance abuse treatment or recovery. J Consult Clin Psychol. 2004 Dec;72(6):1144-56. doi: 10.1037/0022-006X.72.6.1144.
- BackgroundGulliver SB, Wolfsdorf BA, Morissette SB. Treating tobacco dependence: Development of a smoking cessation treatment program for outpatient mental health clinics. Cogn Behav Pract. 2004; 11, 315-330
- Individual participant dataSharing planned: Yes. Data sharing may be considered upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Olando principal investigator
University of Nairobi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group tobacco cessation interventions in people with Mental Illness, run by University of Nairobi at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self reported continued tobacco use abstinence (time frame: Week 4, 12 and 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04013724, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.