Efficacy of Smartphone App for Smoking Cessation in China

Zhejiang University

Status: Completed

Conditions: Cigarette Smoking; Smartphone App-based Smoking Cessation

Treatments: Behavioral: smartphone app for smoking cessation

Study type: Interventional

Funder types: Other

Identifiers

NCT04421170

20200129-33

Details and patient eligibility

About

This study aims to evaluate the efficacy of cognitive behavioral therapy (CBT)-based cigarette smoking cessation smartphone app for treatment seeking smokers in China.

Enrollment: 1,289 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Cigarette smokers (smoked more than 100 cigarettes in their lifetime, and currently smoke five or more cigarettes a day)
2. 25 years of age or older
3. Being able to read and write in Chinese
4. Owning a smartphone
5. Have experience of using apps
6. Expressing an interest in quitting smoking within the next month
7. Willing to provide informed consent to participate in the study

Exclusion criteria

1. Nonsmokers
2. Only use electronic cigarettes
3. Smokers without attempts to quit smoking
4. Participants with severe mental illness
5. Participants who had already started their quit attempt or using any smoking cessation treatment at the time of registration
6. Unable to use smartphone and apps
7. Unable to read and write in Chinese

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,289 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Participants from the intervention group will receive CBT based smoking cessation. It provides both mandatory information of evidence-based and guideline-based smoking cessation interventions, and optional information about quitting benefits, tips for quitting et al. The app will be available for the participants in the intervention group until 26-week post-quit date follow-up. After this period, the app will automatically stop the data collection, but they can continue to use it if they want. As the participants progressed through the study, smoking cessation related information will be gradually reduced until 12 weeks after quit date, and follow-up messages will be sent at 16, 20 and 26 weeks after quit date. Participants from intervention group can also seek for help at any time by text or WeChat, or make a phone call.

Treatment:

Behavioral: smartphone app for smoking cessation

Control group

No Intervention group

Description:

Participants from the control group will only receive information of thanking them for being in the study and reminding them of the time until their free month at the end of follow up. In order to measure the outcomes between two groups, continuous smoking abstinence, point prevalence of abstinence, how many cigarettes per day during the last week if they are still smoking will be checked at week 1, 2, 3, 4, 8, 12, 16, 20 and 26 points after quit date by ePRO software. Biochemically verified continuously abstinence will also be checked if they have reported continuous smoking abstinence at week 26 points after quit date.