ClinicalTrials.gg
Active, not recruitingNCT07887217Updated Oct 21, 2026

THE EFFECT OF A TRANSTHEORETICAL MODEL-BASED CHATBOT SUPPORT INTERVENTION ON SMOKING BEHAVIOR IN UNIVERSITY STUDENTS

An interventional study of Dumansız (Transtheoretical Model-Based Chatbot Support Intervention) in Smoking ( Cigarette), Smoking (Tobacco) Addiction and Smoking Behaviors, sponsored by Seher DÖNER. Active, not recruiting at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Seher DÖNER · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jun 2026, registered Oct 2026).
Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Smoking ( Cigarette)
  • Smoking (Tobacco) Addiction
  • Smoking Behaviors
  • Smoking Cessation
  • Tobacco Smoking

Keywords

  • Smoking Behaviors
  • smoking addiction
  • Smoking cessation
  • Transtheoretical model
  • Nursing
  • Psychiatric nursing
03

In context

Cigarette Smoking

132 studies on the registry are indexed under Cigarette Smoking; 60 are open to participants now.

This study's enrollment of 100 is close to the median of 94 across 114 interventional studies indexed under Cigarette Smoking.

Browse Cigarette Smoking studies →

Lead sponsor

This is the only study on the registry with Seher DÖNER as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Transtheoretical Model-Based Chatbot 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.

    Behavioral: Dumansız (Transtheoretical Model-Based Chatbot Support Intervention)

  • No intervention
    No Chatbot Intervention (Control)

    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.

Interventions

  • BehavioralDumansız (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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline, immediately after the six-week intervention (Week 6)

  2. 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.

    Time frame: Baseline and Week 6

  3. 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.

    Time frame: Baseline and 3 Months After the 6-Week Intervention

  4. 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.

    Time frame: Baseline and 3 months after completion of the 6-week intervention

Secondary outcomes

  1. 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.

    Time frame: Baseline and Week 6

  2. 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.

    Time frame: Baseline and 3 Months After the 6-Week Intervention

  3. 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.

    Time frame: Baseline and Week 6

  4. 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.

    Time frame: Baseline and 3 Months After the 6-Week Intervention

  5. 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.

    Time frame: Baseline and Week 6

  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.

    Time frame: Baseline and 3 Months After the 6-Week Intervention

  7. 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.

    Time frame: Baseline and Week 6

  8. 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.

    Time frame: Baseline and 3 Months After the 6-Week Intervention

  9. 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).

    Time frame: Week 6

07

Study locations

1 site
  • Yozgat Bozok University
    Yozgat, Merkez 66100, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Nov 2026, 5 months after the start.

Of 64 non-industry interventional studies with no phase under Cigarette Smoking, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 53. This study's planned 5 months is below that.

Counting every sponsor, half of 66 studies reached it within 28 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2026
First posted
Oct 21, 2026
StartActual
Jun 25, 2026
Primary completionEst.
Nov 30, 2026
CompletionEst.
Feb 28, 2027
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07887217
Lead sponsor
Seher DÖNER
Responsible party
Seher DÖNER (Research Assistant, Istanbul University - Cerrahpasa) — Sponsor-investigator
First posted
Oct 21, 2026
Start date
Jun 25, 2026
Primary completion
Nov 30, 2026 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

Sevil Yılmaz, PhD
study chair · Istanbul University - Cerrahpasa

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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