Protocol for a Smoking Cessation Program With CBT Text and Mindfulness Audio Support: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Biological Verification of Abstinence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: cognitive behaviour thearpy (Other)
结局指标
主要结局
Biological Verification of Abstinence
时间窗: 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.
次要结局
- 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)