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

April 21, 2025 updated by: Sir Run Run Shaw Hospital

Protocol for a Smoking Cessation Program With CBT Text 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hangzhou, China
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: cognitive behaviour thearpy
Participants will access the CBT text materials through a dedicated platform
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Assessed using a visual analog scale (VAS)
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 26.
Emotional Regulation
Time Frame: Baseline, Week 12, and Week 26
Evaluated using the Depression, Anxiety, and Stress Scale (DASS-21)
Baseline, Week 12, and Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Run Run Shaw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-2068-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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