Efficacy of Smartphone App for Smoking Cessation in China

Cigarette Smoking Clinical Trial

Official title:

Efficacy of Cognitive Behavioral Therapy-based Smartphone App for Smoking Cessation in China: a Study Protocol of a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421170
• Other study ID #: 20200129-33
• Status: Completed
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: April 15, 2023

Study information

• Verified date: November 2023
• Source: Sir Run Run Shaw Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1289
• Est. completion date: April 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking
• Smartphone App-based Smoking Cessation

Intervention

Behavioral:
• smartphone app for smoking cessation
Paticipants will receive 12-week app-based smoking cessation intervention with follow-up to 26 weeks.

Locations

Country	Name	City	State
China	Yanhui Liao	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biologically verified continuously smoking abstinence at week 26	Participants in this study will be considered to be biologically verified continuously smoking abstinence if they report smoking no more than 5 cigarettes since the quit date and have an expired carbon monoxide concentration of less than 10 ppm (for local participants who will be able to go to the PI affiliated hospital) or a urine cotinine cutoff point of 200 ng/ml (cotinine urine dipsticks will be mailed to each participant's address, and test will be confirmed by video call and by family members) at week 26 (6 months) after quit date. This abstinence has been applied by the Society for Research on Nicotine and Tobacco (SRNT) (Hughes, Keely et al. 2003) and the 'Russell Standard' (West, Hajek et al. 2005).	26 weeks
Secondary	7-day point prevalence smoking abstinence	7-day Point prevalence of smoking abstinence: not even a puff of smoke, for the last seven consecutive days, at 1, 2, 3, 4, 8, 12, 16, 20 and 26 weeks.	26 weeks
Secondary	Self-reported continuous smoking abstinence	Self-reported continuous smoking abstinence: a self-report of smoking = 5 cigarettes from the past 1, 2, 3, 4, 8, 12, 16, 20 and 26 weeks.	26 weeks
Secondary	Reductions in number of cigarettes smoked per day	Reductions in number of cigarettes smoked per day: will be assessed by comparing the number of cigarettes smoked per day at baseline and at 26 weeks. Cigarettes smoked per day: number of cigarettes smoked per day within seven days or the approximate total number of smoked cigarettes within seven days if not smoked daily.	26 weeks