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

NCT06901713 | Recruiting

• 1 other identifier: 2024-2068-01
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Tobacco Dependence

Outcome Measures

Primary Outcomes (1)

• Biological Verification of Abstinence

  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.

  6 Months

Secondary Outcomes (3)

• 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

Study Arms (2)

CBT text-based program alone

ACTIVE COMPARATOR

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.

Other: cognitive behaviour thearpy

CBT text combined with mindfulness audio

EXPERIMENTAL

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.

Other: cognitive behaviour thearpy; Other: mindfulness

Interventions

cognitive behaviour thearpy OTHER

Participants will access the CBT text materials through a dedicated platform

CBT text combined with mindfulness audio; CBT text-based program alone

mindfulness OTHER

Participants will access the mindfulness audio via a compatible device

CBT text combined with mindfulness audio

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, China

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Yanhui Liao

CONTACT

86 18814898844; liaoyanhui@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: October 9, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)