NCT07887217

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Jun 2026Feb 2027

Study Start

First participant enrolled

June 25, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

5 months

First QC Date

October 15, 2026

Last Update Submit

October 20, 2026

Conditions

Keywords

Smoking Behaviorssmoking addictionSmoking cessationTranstheoretical modelNursingPsychiatric nursing

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    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

    Baseline and Week 6

  • Change in Smoking Cessation Self-Efficacy from Baseline to 3 Months After the 6-Week Intervention

    Baseline and 3 Months After the 6-Week Intervention

  • Change in Decisional Balance for Smoking Cessation from Baseline to Week 6

    Baseline and Week 6

  • Change in Decisional Balance for Smoking Cessation from Baseline to 3 Months After the 6-Week Intervention

    Baseline and 3 Months After the 6-Week Intervention

  • Change in Cigarette Craving Scores from Baseline to Week 6

    Baseline and Week 6

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

"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.

Transtheoretical Model-Based Chatbot Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yozgat Bozok University

Yozgat, Merkez, 66100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cigarette SmokingSmokingBehavior, AddictiveSmoking CessationTobacco Smoking

Condition Hierarchy (Ancestors)

BehaviorTobacco UseCompulsive BehaviorImpulsive BehaviorHealth Behavior

Study Officials

  • Sevil Yılmaz, PhD

    Istanbul University - Cerrahpasa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 15, 2026

First Posted

October 21, 2026

Study Start

June 25, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

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.

Locations