Tobacco Use DisorderNCT06930547
Effectiveness of Smoking Cessation Education
A study testing Experimental in people with Tobacco Use Disorder and Mental Disorders, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial summary
Smoking is an important psychosocial problem that concerns society. It is reported that 1.3 billion people use tobacco products in the world and approximately 6 million people lose their lives due to smoking every year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder, Mental Disorders, Smoking Cessation
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2024to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being registered with TRSM (Community Mental Health Center)
- Being in the remission phase (the period after the patient's treatment is completed, with no observed active symptoms and improved insight)
- Smoking at least one cigarette per day regularly
- Being open to communication and collaboration
- Being over the age of 18
- Volunteering to participate in the study.
Who cannot join
- Not being registered with TRSM (Community Mental Health Center)
- Not being in the remission phase (presence of active symptoms or lack of improved insight)
- Smoking less than one cigarette per day
- Being unwilling or unable to communicate and collaborate effectively
- Being under the age of 18
- Not volunteering or unwilling to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ayşe METİN, PHD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erzurum Community Mental Health Center
Erzurum, Erzurum, 25050
Zeynep ÖZTÜRK, PHD, 05397968899 ext. 44452464, zeynepolcun6@gmail.com
Ayşe METİN, PHD, 05066812398, ayse.metin@erzurum.edu.tr
About this study
Official title: Investigation of the Effectiveness of Smoking Cessation Education in Patients Registered at a Community Mental Health Center: A Randomized Controlled Trial
Smoking is an important psychosocial problem that concerns society. It is reported that 1.3 billion people use tobacco products in the world and approximately 6 million people lose their lives due to smoking every year. Despite the high mortality rate, smoking addiction is shown as one of the biggest preventable diseases and causes of death. Individuals with mental health problems have a much higher smoking rate than the general population. Studies show that people with severe mental disorders such as schizophrenia, bipolar disorder and major depression have a smoking rate three to four times higher than the general population. It has been reported that this high smoking rate is associated with more morbidity, mortality and increased healthcare costs in individuals with severe mental disorders.
It is reported that nurses, who spend the most time with patients and constitute the largest group of healthcare personnel, have an effective role in smoking cessation initiatives. The importance of nurses in tobacco control is emphasized in the publication titled "Nurses for a Tobacco-Free Life" by the International Council of Nursing (ICN). Although both national and international literature demonstrates that smoking is a serious problem in individuals with severe mental illness through descriptive research results, it is seen that smoking cessation intervention studies are quite limited. Randomized controlled intervention studies examining the effectiveness of smoking cessation interventions applied by nurses to individuals with severe mental illnesses could not be found in the literature. This study will be conducted to examine the effectiveness of smoking cessation education in patients registered in a community mental health center.
In light of this information, this study was planned as a randomized controlled study to examine the effectiveness of smoking cessation education in patients registered in a community mental health center. The data obtained from this study will reveal the effectiveness of smoking cessation education in individuals with severe mental illnesses and contribute to filling the gap in the literature in this area. In addition, a method for using smoking cessation education in individuals with severe mental illnesses will be presented with a high level of evidence study.
Read the detailed description
Smoking is a significant psychosocial issue that affects society. The substance responsible for smoking addiction is nicotine, which has a stronger addictive potential than other psychoactive substances. Tobacco, in addition to its many physical health risks, is also a psychoactive substance that can lead to mental and behavioral disorders. It is estimated that 1.3 billion people worldwide use tobacco products, and approximately 8 million people die each year due to smoking. Despite the high mortality rate, smoking addiction is considered one of the leading preventable causes of disease and death.
Individuals with mental health disorders have significantly higher smoking rates compared to the general population. Studies indicate that people diagnosed with schizophrenia, bipolar disorder, and major depression smoke at a rate three to four times higher than the general public. This high smoking prevalence among individuals with severe mental illness is associated with increased morbidity, mortality, and higher healthcare costs. Reducing the burden of physical illness among people with mental disorders is recognized as a national priority, making smoking cessation among these individuals particularly important.
Nurses, who form the largest group among healthcare professionals and spend the most time with patients, play a crucial role in smoking cessation efforts. Nurses are expected to be actively involved in smoking prevention and cessation. International health authorities emphasize the need for nurses to be at the forefront of tobacco control efforts.
Global smoking cessation campaigns primarily target healthy individuals as part of preventive health strategies. However, special groups such as psychiatric patients should also be included in smoking cessation initiatives. Research indicates that a significant proportion of individuals with mental illness who smoke express a desire to quit. Furthermore, interventions that enhance smoking cessation success among the general population are also effective for individuals with mental health disorders. It is strongly recommended that evidence-based smoking cessation interventions be applied to individuals with mental disorders, just as they are to the general population.
Given the high prevalence of nicotine addiction among individuals with mental disorders and the preventable nature of smoking-related deaths, the importance of smoking cessation initiatives becomes evident. However, research has shown that mental health teams do not consistently implement evidence-based smoking cessation interventions. Although literature highlights the severity of smoking issues among individuals with severe mental illness, studies on smoking cessation interventions remain limited. Notably, randomized controlled trials examining the effectiveness of nurse-led smoking cessation interventions for this population are scarce.
This study aims to evaluate the effectiveness of smoking cessation education among patients registered at community mental health centers. It is expected to contribute to reducing smoking addiction, which is prevalent among individuals with mental disorders, while also raising awareness among mental health professionals, particularly nurses, about the importance of smoking cessation efforts.
- Conditions
- Tobacco Use Disorder, Mental Disorders, Smoking Cessation
- Being tested
- Experimental
- Keywords
- Tobacco Use Disorder, Mental Disorders, Smoking Cessation
- Medical subject headings
- Tobacco Use Disorder, Mental Disorders, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
In this study, the experimental group will undergo a smoking cessation training program consisting of eight sessions over four weeks, conducted twice a week. Each session is planned to last approximately 40-45 minutes.
During the program, before each session, the previous session will be reviewed to reinforce learning and establish continuity between sessions. Feedback will be collected to ensure engagement and comprehension. At the end of each session, a summary of the session's agenda will be provided.
Before each session, both the experimental and control groups will be evaluated using a smoking cessation status form to assess their progress. Additionally, follow-up assessments will be conducted one month and three months after the program to test the retention of the training's effectiveness.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | This group will not receive the smoking cessation training. |
| İntervention | Experimental | Smoking cessation training will be applied to this group Receives: Other: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fagerström Test for Nicotine Dependence (FTND):
Developed in 1991 by Heatherton and colleagues (Heatherton et al., 1991), the FTND is a self-assessment scale used to evaluate individuals' risk of physical nicotine dependence, measure the level and intensity of addiction. It includes binary and four-point Likert-type questions, ranging between 0-1 and 0-3. The test consists of six questions, and the total score can range from 0 to 10 points. Based on the score, individuals are categorized as follows:
0-2 points: "Very low dependence"
3-4 points: "Low dependence"
5 points: "Moderate dependence"
6-7 points: "High dependence"
8-10 points: "Very high dependence" (Uysal et al., 2004; Güneş Ersoy, 2019).
Measured: Pre-test before the training, Post-test immediately after the training, 1st follow-up 1 month after the training, 2nd follow-up 3 months after the 1st follow-up
Self-Efficacy Scale
According to Karancı, the Self-Efficacy Scale (SES) was developed in 1984 by Nicki and colleagues. Based on social learning theories, the concept relates to an individual's belief in their ability to perform a desired behavior. Strengthening this belief is frequently used in smoking cessation efforts. The validity and reliability studies of the Self-Efficacy Scale were conducted by Karancı (1992). The scale consists of 25 items, and each item is rated on a 1-5 scale, with the options ranging from "Not sure at all: 1" to "Absolutely sure: 5". The total score ranges from 25 to 125. A higher score reflects a stronger belief in the ability to quit smoking. As the score increases, so does the belief in one's ability to quit smoking (Karancı, 1992).
Measured: Pre-test before the training, Post-test immediately after the training, 1st follow-up 1 month after the training, 2nd follow-up 3 months after the 1st follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start5 Dec 2024
- Primary completion5 May 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group Control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeynep ÖZTÜRK, PHD, Principal investigator, Erzurum Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930547
- Sponsor's protocol ID
- 151605122024
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Smoking Cessation Education in Patients Registered at a Community Mental Health Center: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06930547
- Acronym / sponsor ID
- 151605122024
- Conditions
- Tobacco Use Disorder, Mental Disorders, Smoking Cessation
- Keywords
- Tobacco Use Disorder, Mental Disorders, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 5 May 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 16 Apr 2025 (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.
Smoking is an important psychosocial problem that concerns society. It is reported that 1.3 billion people use tobacco products in the world and approximately 6 million people lose their lives due to smoking every year. Despite the high mortality rate, smoking addiction is shown as one of the biggest preventable diseases and causes of death. Individuals with mental health problems have a much higher smoking rate than the general population. Studies show that people with severe mental disorders such as schizophrenia, bipolar disorder and major depression have a smoking rate three to four times higher than the general population. It has been reported that this high smoking rate is associated with more morbidity, mortality and increased healthcare costs in individuals with severe mental disorders.
It is reported that nurses, who spend the most time with patients and constitute the largest group of healthcare personnel, have an effective role in smoking cessation initiatives. The importance of nurses in tobacco control is emphasized in the publication titled "Nurses for a Tobacco-Free Life" by the International Council of Nursing (ICN). Although both national and international literature demonstrates that smoking is a serious problem in individuals with severe mental illness through descriptive research results, it is seen that smoking cessation intervention studies are quite limited. Randomized controlled intervention studies examining the effectiveness of smoking cessation interventions applied by nurses to individuals with severe mental illnesses could not be found in the literature. This study will be conducted to examine the effectiveness of smoking cessation education in patients registered in a community mental health center.
In light of this information, this study was planned as a randomized controlled study to examine the effectiveness of smoking cessation education in patients registered in a community mental health center. The data obtained from this study will reveal the effectiveness of smoking cessation education in individuals with severe mental illnesses and contribute to filling the gap in the literature in this area. In addition, a method for using smoking cessation education in individuals with severe mental illnesses will be presented with a high level of evidence study.
Detailed description
Smoking is a significant psychosocial issue that affects society. The substance responsible for smoking addiction is nicotine, which has a stronger addictive potential than other psychoactive substances. Tobacco, in addition to its many physical health risks, is also a psychoactive substance that can lead to mental and behavioral disorders. It is estimated that 1.3 billion people worldwide use tobacco products, and approximately 8 million people die each year due to smoking. Despite the high mortality rate, smoking addiction is considered one of the leading preventable causes of disease and death.
Individuals with mental health disorders have significantly higher smoking rates compared to the general population. Studies indicate that people diagnosed with schizophrenia, bipolar disorder, and major depression smoke at a rate three to four times higher than the general public. This high smoking prevalence among individuals with severe mental illness is associated with increased morbidity, mortality, and higher healthcare costs. Reducing the burden of physical illness among people with mental disorders is recognized as a national priority, making smoking cessation among these individuals particularly important.
Nurses, who form the largest group among healthcare professionals and spend the most time with patients, play a crucial role in smoking cessation efforts. Nurses are expected to be actively involved in smoking prevention and cessation. International health authorities emphasize the need for nurses to be at the forefront of tobacco control efforts.
Global smoking cessation campaigns primarily target healthy individuals as part of preventive health strategies. However, special groups such as psychiatric patients should also be included in smoking cessation initiatives. Research indicates that a significant proportion of individuals with mental illness who smoke express a desire to quit. Furthermore, interventions that enhance smoking cessation success among the general population are also effective for individuals with mental health disorders. It is strongly recommended that evidence-based smoking cessation interventions be applied to individuals with mental disorders, just as they are to the general population.
Given the high prevalence of nicotine addiction among individuals with mental disorders and the preventable nature of smoking-related deaths, the importance of smoking cessation initiatives becomes evident. However, research has shown that mental health teams do not consistently implement evidence-based smoking cessation interventions. Although literature highlights the severity of smoking issues among individuals with severe mental illness, studies on smoking cessation interventions remain limited. Notably, randomized controlled trials examining the effectiveness of nurse-led smoking cessation interventions for this population are scarce.
This study aims to evaluate the effectiveness of smoking cessation education among patients registered at community mental health centers. It is expected to contribute to reducing smoking addiction, which is prevalent among individuals with mental disorders, while also raising awareness among mental health professionals, particularly nurses, about the importance of smoking cessation efforts.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Experimental group Control group
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –This group will not receive the smoking cessation training. |
| İntervention | Experimental | Other: ExperimentalSmoking cessation training will be applied to this group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being registered with TRSM (Community Mental Health Center)
- Being in the remission phase (the period after the patient's treatment is completed, with no observed active symptoms and improved insight)
- Smoking at least one cigarette per day regularly
- Being open to communication and collaboration
- Being over the age of 18
Key exclusion criteria (6 listed)
- Not being registered with TRSM (Community Mental Health Center)
- Not being in the remission phase (presence of active symptoms or lack of improved insight)
- Smoking less than one cigarette per day
- Being unwilling or unable to communicate and collaborate effectively
- Being under the age of 18
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 |
|---|---|---|
| ExperimentalIn this study, the experimental group will undergo a smoking cessation training program consisting of eight sessions over four weeks, conducted twice a week. Each session is planned to last approximately 40-45 minutes. During the program, before each session, the previous session will be reviewed to reinforce learning and establish continuity between sessions. Feedback will be collected to ensure engagement and comprehension. At the end of each session, a summary of the session's agenda will be provided. Before each session, both the experimental and control groups will be evaluated using a smoking cessation status form to assess their progress. Additionally, follow-up assessments will be conducted one month and three months after the program to test the retention of the training's effectiveness. | Other | İntervention |
Primary outcome
Fagerström Test for Nicotine Dependence (FTND):
Time frame: Pre-test before the training, Post-test immediately after the training, 1st follow-up 1 month after the training, 2nd follow-up 3 months after the 1st follow-up
Developed in 1991 by Heatherton and colleagues (Heatherton et al., 1991), the FTND is a self-assessment scale used to evaluate individuals' risk of physical nicotine dependence, measure the level and intensity of addiction. It includes binary and four-point Likert-type questions, ranging between 0-1 and 0-3. The test consists of six questions, and the total score can range from 0 to 10 points. Based on the score, individuals are categorized as follows: 0-2 points: "Very low dependence" 3-4 points: "Low dependence" 5 points: "Moderate dependence" 6-7 points: "High dependence" 8-10 points: "Very high dependence" (Uysal et al., 2004; Güneş Ersoy, 2019).
Self-Efficacy Scale
Time frame: Pre-test before the training, Post-test immediately after the training, 1st follow-up 1 month after the training, 2nd follow-up 3 months after the 1st follow-up
According to Karancı, the Self-Efficacy Scale (SES) was developed in 1984 by Nicki and colleagues. Based on social learning theories, the concept relates to an individual's belief in their ability to perform a desired behavior. Strengthening this belief is frequently used in smoking cessation efforts. The validity and reliability studies of the Self-Efficacy Scale were conducted by Karancı (1992). The scale consists of 25 items, and each item is rated on a 1-5 scale, with the options ranging from "Not sure at all: 1" to "Absolutely sure: 5". The total score ranges from 25 to 125. A higher score reflects a stronger belief in the ability to quit smoking. As the score increases, so does the belief in one's ability to quit smoking (Karancı, 1992).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Ayşe METİN, PHD contact
Zeynep ÖZTÜRK, PHD principal investigator
Erzurum Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Tobacco Use Disorder and Mental Disorders, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Apr 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeynep ÖZTÜRK, PHD (90539-796-88-99, zeynepolcun6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fagerström Test for Nicotine Dependence (FTND): (time frame: Pre-test before the training, Post-test immediately after the training, 1st follow-up 1 month after the training, 2nd follow-up 3 months after the 1st follow-up). 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?
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 16 Apr 2025.