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

Last updated: April 21, 2025
Sponsor: Sir Run Run Shaw Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tobacco Use Disorder

Treatment

cognitive behaviour thearpy

mindfulness

Clinical Study ID

NCT06901713
2024-2068-01
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 2000
Treatment Group(s): 2
Primary Treatment: cognitive behaviour thearpy
Phase:
Study Start date:
October 09, 2024
Estimated Completion Date:
November 01, 2026

Study 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.

Connect with a study center

  • Sir Run Run Shaw Hospital

    Hangzhou,
    China

    Active - Recruiting

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