Protocol for a Smoking Cessation Program With CBT Text and Mindfulness Audio Support: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sir Run Run Shaw Hospital
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- Biological Verification of Abstinence
Study Overview
Brief Summary
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.
Detailed Description
Design: A randomized controlled trial (RCT) will be used to compare the outcomes of the two intervention groups.
Setting: The study will be conducted online. Participants will access the CBT text materials through a dedicated platform and the mindfulness audio via a compatible device. Recruitment will be done through social media, community outreach, and online advertisements.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
CBT text-based program alone
Participants in this group will receive CBT text messages focused on smoking cessation strategies, including identifying triggers, developing coping mechanisms, and setting goals. These messages will be sent at regular intervals over the course of the 8-week program.
Intervention: cognitive behaviour thearpy (Other)
CBT text combined with mindfulness audio
In addition to the CBT text messages similar to Group A, participants in this group will also have access to a series of mindfulness audio recordings. These recordings will guide participants through mindfulness exercises such as body scans, breath awareness, and meditation, designed to enhance self-awareness and emotion regulation in the context of smoking cessation. The audio will be provided weekly, corresponding to the weekly themes of the program. Participants in this group will receive emotional support and peer-related information from chatbots.
Intervention: mindfulness (Other)
CBT text combined with mindfulness audio
In addition to the CBT text messages similar to Group A, participants in this group will also have access to a series of mindfulness audio recordings. These recordings will guide participants through mindfulness exercises such as body scans, breath awareness, and meditation, designed to enhance self-awareness and emotion regulation in the context of smoking cessation. The audio will be provided weekly, corresponding to the weekly themes of the program. Participants in this group will receive emotional support and peer-related information from chatbots.
Intervention: cognitive behaviour thearpy (Other)
Outcomes
Primary Outcomes
Biological Verification of Abstinence
Time Frame: 6 Months
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.
Secondary Outcomes
- Smoking Frequency(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.)
- Craving Intensity(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.)
- Emotional Regulation(Baseline, Week 12, and Week 26)