Smoking Cessation Program With CBT and Mindfulness Audio Support: A Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSir Run Run Shaw Hospital
About this trial
This protocol describes a randomized controlled trial evaluating the effectiveness of a smoking cessation program with two intervention methods. One method provides only CBT text messages (Group A), while the other combines CBT text with mindfulness audio (Group B). The study aims to compare the two approaches in reducing smoking frequency, managing cravings, and improving emotional regulation.
This study investigates the effects of two different smoking cessation interventions: (1) CBT text-based program alone (Group A), and (2) CBT text combined with mindfulness audio (Group B). The primary outcomes include reductions in smoking frequency and cravings, as well as improvements in emotional regulation and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Who smoke at least 5 cigarettes per day.
Express a desire to quit or reduce smoking.
Who has the ability to access and use the provided digital materials.
Disqualifiers
Those currently enrolled in other smoking cessation programs.
Individuals with severe psychiatric disorders that may interfere with participation.
Those without access to the necessary digital devices.
Trial design
Design model
Parallel
Treatments tested in this trial
cognitive behaviour thearpy
Other interventionParticipants will access the CBT text materials through a dedicated platform
mindfulness
Other interventionParticipants will access the mindfulness audio via a compatible device
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: CBT text-based program aloneActive comparator 1 intervention
Group B: CBT text combined with mindfulness audioExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Biological Verification of Abstinence
Confirmation of smoking abstinence at the end of the study period using cotinine test strips. This will be the main measure to assess the effectiveness of the smoking cessation interventions.
Time frame
6 MonthsSecondary outcomes
1
Smoking Frequency
Measured by the number of cigarettes smoked per day at baseline
Time frame
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.2
Craving Intensity
Assessed using a visual analog scale (VAS)
Time frame
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.3
Emotional Regulation
Evaluated using the Depression, Anxiety, and Stress Scale (DASS-21)
Time frame
Baseline, Week 12, and Week 26Sponsors and contacts
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Source ClinicalTrials.gov