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Recruiting NCT06901713

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

No phase Interventional Smoking Cessation; Tobacco Dependence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cognitive behaviour thearpy, mindfulness.
Who it may be relevant to
Registry conditions: Smoking Cessation; Tobacco Dependence. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Protocol for a Smoking Cessation Program With CBT Text and Mindfulness Audio Support: A Randomized Controlled Trial

Overview

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.

Interventions

  • Other cognitive behaviour thearpy
    Participants will access the CBT text materials through a dedicated platform
  • Other mindfulness
    Participants will access the mindfulness audio via a compatible device

Primary outcome measures

  • Biological Verification of Abstinence [Time frame: 6 Months]
Secondary outcome measures (3)
  • Smoking Frequency [Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.]
  • Craving Intensity [Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.]
  • Emotional Regulation [Time frame: Baseline, Week 12, and Week 26]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Sir Run Run Shaw Hospital — Hangzhou

Publications

  • Li S, Meng L, Chiolero A, Ma C, Xi B. Trends in smoking prevalence and attributable mortality in China, 1991-2011. Prev Med. 2016 Dec;93:82-87. doi: 10.1016/j.ypmed.2016.09.027. Epub 2016 Sep 24. PMID 27677441
  • Li Q, Hsia J, Yang G. Prevalence of smoking in China in 2010. N Engl J Med. 2011 Jun 23;364(25):2469-70. doi: 10.1056/NEJMc1102459. No abstract available. PMID 21696322
  • Chen R, Ye R, Liao Y. Smoking cessation with CBT and mindfulness: study protocol for a randomized controlled trial. Trials. 2026 Mar 19;27(1):325. doi: 10.1186/s13063-026-09611-9. PMID 41857743

Identifiers

NCT: NCT06901713 · 2024-2068-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗