Smoking Cessation Program With CBT and Mindfulness Audio Support: A Randomized Controlled Trial

Zhejiang University

Status: Enrolling

Conditions: Smoking Cessation; Tobacco Dependence

Treatments: Other: mindfulness; Other: cognitive behaviour thearpy

Study type: Interventional

Funder types: Other

Identifiers

NCT06901713

2024-2068-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

2,000 participants in 2 patient groups

CBT text-based program alone

Active Comparator group

Description:

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.

Treatment:

Other: cognitive behaviour thearpy

CBT text combined with mindfulness audio

Experimental group

Description:

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.

Treatment:

Other: cognitive behaviour thearpy

Other: mindfulness