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

NCT ID: NCT06901713

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-09

Study Completion Date

2026-11-01

Brief Summary

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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

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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.

Conditions

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Smoking Cessation; Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CBT text-based program alone

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.

Group Type ACTIVE_COMPARATOR

cognitive behaviour thearpy

Intervention Type OTHER

Participants will access the CBT text materials through a dedicated platform

CBT text combined with mindfulness audio

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.

Group Type EXPERIMENTAL

cognitive behaviour thearpy

Intervention Type OTHER

Participants will access the CBT text materials through a dedicated platform

mindfulness

Intervention Type OTHER

Participants will access the mindfulness audio via a compatible device

Interventions

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cognitive behaviour thearpy

Participants will access the CBT text materials through a dedicated platform

Intervention Type OTHER

mindfulness

Participants will access the mindfulness audio via a compatible device

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Run Run Shaw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sir Run Run Shaw Hospital

Hangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanhui Liao

Role: CONTACT

86 18814898844

Facility Contacts

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Yanhui Liao

Role: primary

+86 18814898844

References

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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.

Reference Type BACKGROUND
PMID: 27677441 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21696322 (View on PubMed)

Other Identifiers

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2024-2068-01

Identifier Type: -

Identifier Source: org_study_id

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