Smoking ( Cigarette)NCT07887217
THE EFFECT OF A TRANSTHEORETICAL MODEL-BASED CHATBOT SUPPORT INTERVENTION ON SMOKING BEHAVIOR IN UNIVERSITY STUDENTS
A study testing Dumansız (Transtheoretical Model-Based Chatbot Support Intervention) in people with Smoking ( Cigarette) and Smoking (Tobacco) Addiction, run by Seher DÖNER at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this clinical trial is to examine the impact of a chatbot-supported intervention based on the Transtheoretical Model (TTM) on smoking behavior, self-efficacy, decisional balance, and the urge to smoke among university students. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking ( Cigarette), Smoking (Tobacco) Addiction, Smoking Behaviors
- What is being tested?
- Dumansız (Transtheoretical Model-Based Chatbot Support Intervention)
- 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 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2026to 28 Feb 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Being a student enrolled at Yozgat Bozok University in the 2025-2026 academic year,
- Being an active smoker (smoking at least one cigarette a day),
- Being in the 'Pre-contemplation', 'Contemplation' or 'Preparation' stages of the behavioural change process,
- Using a personal smartphone.
Who cannot join
- Receiving professional support for smoking cessation,
- Being in the 'Action' and 'Maintenance' stages of the behavioural change process,
- Having a diagnosis of a serious mental health condition,
- Failure to comply with the research protocol (failing to reply to or read messages),
- Incomplete completion of data collection forms and scales.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this clinical trial is to examine the impact of a chatbot-supported intervention based on the Transtheoretical Model (TTM) on smoking behavior, self-efficacy, decisional balance, and the urge to smoke among university students. The main questions it aims to answer are:
- Does the chatbot-based support intervention, grounded in the Transtheoretical Model (TTM), have an effect on smoking behavior?
- Does the chatbot-based support intervention, grounded in the Transtheoretical Model (TTM), have an effect on self-efficacy levels?
- Does the chatbot-based support intervention, grounded in the Transtheoretical Model (TTM), have an effect on decisional balance?
- Does the chatbot-based support intervention, grounded in the Transtheoretical Model (TTM), have an effect on the urge to smoke? The researchers will compare the experimental group with a group that received no intervention to determine whether the chatbot is effective in influencing smoking behavior.
Read more
Participants will:
- Complete the preliminary assessment questionnaire.
- If you are in the experimental group, access the Telegram chatbot via the provided link and exchange messages with the bot once a week for a total of 6 weeks (each session will take approximately 10 minutes). Additionally, read the informational messages sent twice a week and try to incorporate the suggestions into your daily life.
- Complete the follow-up questionnaires that will be sent after 6 weeks and again after 3 months.
- Conditions
- Smoking ( Cigarette), Smoking (Tobacco) Addiction, Smoking Behaviors, Smoking Cessation, Tobacco Smoking
- Being tested
- Dumansız (Transtheoretical Model-Based Chatbot Support Intervention)
- Keywords
- Smoking Behaviors, smoking addiction, Smoking cessation, Transtheoretical model, Nursing, Psychiatric nursing
- Medical subject headings
- Cigarette Smoking, Smoking, Behavior, Addictive, Smoking Cessation, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dumansız (Transtheoretical Model-Based Chatbot Support Intervention)Behavioural
"Dumansız" is a six-week, Transtheoretical Model (TTM)-based chatbot support intervention delivered via Telegram. The chatbot is scenario-based, semi-interactive, and rule-based; it does not use artificial intelligence or analyze free-text responses. Standardized responses are provided through predefined message flows and response options. Content is tailored to participants in the precontemplation, contemplation, or preparation stage of change. The intervention includes one interactive text-based session (approximately 5-10 minutes) and two brief informational or motivational messages per week, which may include text, videos, or educational materials. Stage of change is reassessed every two weeks, and message flows are adjusted when a participant's stage changes. The intervention draws on TTM processes of change and uses communication principles and techniques from motivational interviewing to support awareness, motivation, decisional balance, and self-efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Transtheoretical Model-Based Chatbot Intervention | Experimental | Participants assigned to this arm will receive a six-week, Transtheoretical Model-based, scenario-based, semi-interactive, rule-based chatbot intervention delivered via Telegram to support smoking behavior change. The intervention includes weekly interactive sessions and two brief informational or motivational messages per week. The chatbot content is designed to address participants' stage of change, smoking-related triggers, barriers to quitting, coping strategies, and self-efficacy. Receives: Behavioral: Dumansız (Transtheoretical Model-Based Chatbot Support Intervention) |
| No Chatbot Intervention (Control) | No intervention | Participants assigned to this arm will not receive the chatbot intervention during the study period. They will complete the same assessments as the intervention group at baseline, immediately after the six-week intervention period, and at three-month follow-up. Smoking cessation educational material will be provided after completion of the final follow-up assessment. In addition, participants who wish to receive the chatbot intervention may be offered access to it after the study has ended. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Reporting Smoking Cessation at Week 6
Smoking cessation status will be assessed by participant self-report. The outcome is the proportion of participants who report having stopped smoking cigarettes at Week 6, compared between the intervention and control groups.
Measured: At baseline, immediately after the six-week intervention (Week 6)
Change in Stage of Change for Smoking Cessation from Baseline to Week 6
Stage of change will be assessed using the Stage of Change Questionnaire based on the Transtheoretical Model. Participants will be classified into precontemplation, contemplation, preparation, action, or maintenance. Change in stage from baseline to Week 6 will be evaluated and compared between the intervention and control groups.
Measured: Baseline and Week 6
Proportion of Participants Reporting Smoking Cessation at 3 Months After the 6-Week Intervention
The proportion of participants who report having stopped smoking 3 months after completion of the 6-week intervention.
Measured: Baseline and 3 Months After the 6-Week Intervention
Change in Stage of Change for Smoking Cessation from Baseline to 3 Months After the 6-Week Intervention
Change in participants' stage of change for smoking cessation, classified as precontemplation, contemplation, preparation, action, or maintenance, from baseline to 3 months after completion of the 6-week intervention.
Measured: Baseline and 3 months after completion of the 6-week intervention
Secondary outcomes (9)
Change in Smoking Cessation Self-Efficacy from Baseline to Week 6
Change in participants' smoking cessation self-efficacy scores, measured using the Self-Efficacy Scale, from baseline to the end of the 6-week intervention period.
Measured: Baseline and Week 6
Change in Smoking Cessation Self-Efficacy from Baseline to 3 Months After the 6-Week Intervention
Change in participants' smoking cessation self-efficacy scores, measured using the Self-Efficacy Scale, from baseline to 3 months after completion of the 6-week intervention.
Measured: Baseline and 3 Months After the 6-Week Intervention
Change in Decisional Balance for Smoking Cessation from Baseline to Week 6
Change in participants' decisional balance scores regarding smoking cessation, measured using the Decisional Balance Scale, from baseline to Week 6.
Measured: Baseline and Week 6
Change in Decisional Balance for Smoking Cessation from Baseline to 3 Months After the 6-Week Intervention
Change in participants' decisional balance scores regarding smoking cessation, measured using the Decisional Balance Scale, from baseline to 3 months after completion of the 6-week intervention.
Measured: Baseline and 3 Months After the 6-Week Intervention
Change in Cigarette Craving Scores from Baseline to Week 6
Change in participants' cigarette craving scores, measured using the Cigarette Craving Scale, from baseline to Week 6.
Measured: Baseline and Week 6
Change in Cigarette Craving Scores from Baseline to 3 Months After the 6-Week Intervention
Change in participants' cigarette craving scores, measured using the Cigarette Craving Scale, from baseline to 3 months after completion of the 6-week intervention.
Measured: Baseline and 3 Months After the 6-Week Intervention
Change in Nicotine Dependence Scores from Baseline to Week 6
Change in participants' nicotine dependence scores, measured using the Fagerström Test for Nicotine Dependence (FTND), from baseline to Week 6.
Measured: Baseline and Week 6
Change in Nicotine Dependence Scores from Baseline to 3 Months After the 6-Week Intervention
Change in participants' nicotine dependence scores, measured using the Fagerström Test for Nicotine Dependence (FTND), from baseline to 3 months after completion of the 6-week intervention.
Measured: Baseline and 3 Months After the 6-Week Intervention
Participant Satisfaction with the Chatbot Intervention
Participants' satisfaction with the chatbot intervention will be assessed using a 5-point rating question ranging from 1 (not at all satisfied) to 5 (very satisfied). Participants' likelihood of recommending the intervention to a friend will be assessed using a rating scale ranging from 0 (not at all likely) to 10 (extremely likely).
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start25 Jun 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking ( Cigarette)Studies 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
- Participants will be randomly assigned to two parallel groups. The intervention group will receive a six-week Transtheoretical Model-based chatbot intervention to support smoking behavior change. The control group will receive no chatbot intervention during the study period. Both groups will complete assessments at the same time points, including baseline, post-intervention, and three-month follow-up.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seher DÖNER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seher DÖNER, Istanbul University - Cerrahpasa
- Investigators
- Sevil Yılmaz, PhD, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887217
- Sponsor's protocol ID
- TTMCHAT2026
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers due to participant confidentiality and data protection considerations. Study results will be reported in aggregate form, without identifying individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF A TRANSTHEORETICAL MODEL-BASED CHATBOT SUPPORT INTERVENTION ON SMOKING BEHAVIOR IN UNIVERSITY STUDENTS
- ClinicalTrials.gov ID
- NCT07887217
- Acronym / sponsor ID
- TTMCHAT2026
- Conditions
- Smoking ( Cigarette), Smoking (Tobacco) Addiction, Smoking Behaviors, Smoking Cessation, Tobacco Smoking
- Keywords
- Smoking Behaviors, smoking addiction, Smoking cessation, Transtheoretical model, Nursing, Psychiatric nursing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seher DÖNERUniversity, hospital or other
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 21 Oct 2026 (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 purpose of this clinical trial is to examine the impact of a chatbot-supported intervention based on the Transtheoretical Model (TTM) on smoking behavior, self-efficacy, decisional balance, and the urge to smoke among university students. The main questions it aims to answer are:
- Does the chatbot-based support intervention, grounded in the Transtheoretical Model (TTM), have an effect on smoking behavior?
- Does the chatbot-based support intervention, grounded in the Transtheoretical Model (TTM), have an effect on self-efficacy levels?
- Does the chatbot-based support intervention, grounded in the Transtheoretical Model (TTM), have an effect on decisional balance?
- Does the chatbot-based support intervention, grounded in the Transtheoretical Model (TTM), have an effect on the urge to smoke? The researchers will compare the experimental group with a group that received no intervention to determine whether the chatbot is effective in influencing smoking behavior.
Participants will:
- Complete the preliminary assessment questionnaire.
- If you are in the experimental group, access the Telegram chatbot via the provided link and exchange messages with the bot once a week for a total of 6 weeks (each session will take approximately 10 minutes). Additionally, read the informational messages sent twice a week and try to incorporate the suggestions into your daily life.
- Complete the follow-up questionnaires that will be sent after 6 weeks and again after 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two parallel groups. The intervention group will receive a six-week Transtheoretical Model-based chatbot intervention to support smoking behavior change. The control group will receive no chatbot intervention during the study period. Both groups will complete assessments at the same time points, including baseline, post-intervention, and three-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Transtheoretical Model-Based Chatbot Intervention | Experimental | Behavioral: Dumansız (Transtheoretical Model-Based Chatbot Support Intervention)Participants assigned to this arm will receive a six-week, Transtheoretical Model-based, scenario-based, semi-interactive, rule-based chatbot intervention delivered via Telegram to support smoking behavior change. The intervention includes weekly interactive sessions and two brief informational or motivational messages per week. The chatbot content is designed to address participants' stage of change, smoking-related triggers, barriers to quitting, coping strategies, and self-efficacy. |
| No Chatbot Intervention (Control) | No intervention | –Participants assigned to this arm will not receive the chatbot intervention during the study period. They will complete the same assessments as the intervention group at baseline, immediately after the six-week intervention period, and at three-month follow-up. Smoking cessation educational material will be provided after completion of the final follow-up assessment. In addition, participants who wish to receive the chatbot intervention may be offered access to it after the study has ended. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Being a student enrolled at Yozgat Bozok University in the 2025-2026 academic year,
- Being an active smoker (smoking at least one cigarette a day),
- Being in the 'Pre-contemplation', 'Contemplation' or 'Preparation' stages of the behavioural change process,
- Using a personal smartphone.
Key exclusion criteria (5 listed)
- Receiving professional support for smoking cessation,
- Being in the 'Action' and 'Maintenance' stages of the behavioural change process,
- Having a diagnosis of a serious mental health condition,
- Failure to comply with the research protocol (failing to reply to or read messages),
- Incomplete completion of data collection forms and scales.
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 |
|---|---|---|
| Dumansız (Transtheoretical Model-Based Chatbot Support Intervention)"Dumansız" is a six-week, Transtheoretical Model (TTM)-based chatbot support intervention delivered via Telegram. The chatbot is scenario-based, semi-interactive, and rule-based; it does not use artificial intelligence or analyze free-text responses. Standardized responses are provided through predefined message flows and response options. Content is tailored to participants in the precontemplation, contemplation, or preparation stage of change. The intervention includes one interactive text-based session (approximately 5-10 minutes) and two brief informational or motivational messages per week, which may include text, videos, or educational materials. Stage of change is reassessed every two weeks, and message flows are adjusted when a participant's stage changes. The intervention draws on TTM processes of change and uses communication principles and techniques from motivational interviewing to support awareness, motivation, decisional balance, and self-efficacy. | Behavioural | Transtheoretical Model-Based Chatbot Intervention |
Primary outcome
Proportion of Participants Reporting Smoking Cessation at Week 6
Time frame: At baseline, immediately after the six-week intervention (Week 6)
Smoking cessation status will be assessed by participant self-report. The outcome is the proportion of participants who report having stopped smoking cigarettes at Week 6, compared between the intervention and control groups.
Change in Stage of Change for Smoking Cessation from Baseline to Week 6
Time frame: Baseline and Week 6
Stage of change will be assessed using the Stage of Change Questionnaire based on the Transtheoretical Model. Participants will be classified into precontemplation, contemplation, preparation, action, or maintenance. Change in stage from baseline to Week 6 will be evaluated and compared between the intervention and control groups.
Proportion of Participants Reporting Smoking Cessation at 3 Months After the 6-Week Intervention
Time frame: Baseline and 3 Months After the 6-Week Intervention
The proportion of participants who report having stopped smoking 3 months after completion of the 6-week intervention.
Change in Stage of Change for Smoking Cessation from Baseline to 3 Months After the 6-Week Intervention
Time frame: Baseline and 3 months after completion of the 6-week intervention
Change in participants' stage of change for smoking cessation, classified as precontemplation, contemplation, preparation, action, or maintenance, from baseline to 3 months after completion of the 6-week intervention.
9 secondary outcomes
Change in Smoking Cessation Self-Efficacy from Baseline to Week 6
Time frame: Baseline and Week 6
Change in Smoking Cessation Self-Efficacy from Baseline to 3 Months After the 6-Week Intervention
Time frame: Baseline and 3 Months After the 6-Week Intervention
Change in Decisional Balance for Smoking Cessation from Baseline to Week 6
Time frame: Baseline and Week 6
Change in Decisional Balance for Smoking Cessation from Baseline to 3 Months After the 6-Week Intervention
Time frame: Baseline and 3 Months After the 6-Week Intervention
Change in Cigarette Craving Scores from Baseline to Week 6
Time frame: Baseline and Week 6
Change in Cigarette Craving Scores from Baseline to 3 Months After the 6-Week Intervention
Time frame: Baseline and 3 Months After the 6-Week Intervention
Change in Nicotine Dependence Scores from Baseline to Week 6
Time frame: Baseline and Week 6
Change in Nicotine Dependence Scores from Baseline to 3 Months After the 6-Week Intervention
Time frame: Baseline and 3 Months After the 6-Week Intervention
Participant Satisfaction with the Chatbot Intervention
Time frame: Week 6
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 21 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers due to participant confidentiality and data protection considerations. Study results will be reported in aggregate form, without identifying individual participants.
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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.
Sevil Yılmaz, PhD study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dumansız (Transtheoretical Model-Based Chatbot Support Intervention) in people with Smoking ( Cigarette) and Smoking (Tobacco) Addiction, run by Seher DÖNER 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. 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?
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?
Proportion of Participants Reporting Smoking Cessation at Week 6 (time frame: At baseline, immediately after the six-week intervention (Week 6)). The study lists 4 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 21 Oct 2026.