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

Sir Run Run Shaw Hospital2,000 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

2,000

Conditions

Smoking Cessation; Tobacco Dependence

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 6 Months

Secondary Outcomes

Smoking Frequency

Measured by the number of cigarettes smoked per day at baseline

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

Craving Intensity

Assessed using a visual analog scale (VAS)

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

Emotional Regulation

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

Time frame: Baseline, Week 12, and Week 26