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NCT Number: NCT06901713

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

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.

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Key information

Conditions

Smoking Cessation; Tobacco Dependence Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cognitive behaviour thearpy

Other

Participants will access the CBT text materials through a dedicated platform

Mindfulness

Other

Participants will access the mindfulness audio via a compatible device

Primary outcomes

  1. 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

  1. Smoking Frequency

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.

    Measured by the number of cigarettes smoked per day at baseline

  2. Craving Intensity

    Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.

    Assessed using a visual analog scale (VAS)

  3. Emotional Regulation

    Time frame: Baseline, Week 12, and Week 26

    Evaluated using the Depression, Anxiety, and Stress Scale (DASS-21)

Study contacts

Contact information is provided by the study sponsor or research team.

Yanhui Liao

CONTACT

[email protected]

86 18814898844

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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