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Efficacy of Smartphone App for Smoking Cessation in China

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04421170
Enrollment
1289
Registered
2020-06-09
Start date
2021-02-23
Completion date
2023-04-15
Last updated
2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking, Smartphone App-based Smoking Cessation

Brief 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.

Interventions

BEHAVIORALsmartphone app for smoking cessation

Paticipants will receive 12-week app-based smoking cessation intervention with follow-up to 26 weeks.

Sponsors

Sir Run Run Shaw Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Biologically verified continuously smoking abstinence at week 2626 weeksParticipants 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).

Secondary

MeasureTime frameDescription
7-day point prevalence smoking abstinence26 weeks7-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.
Self-reported continuous smoking abstinence26 weeksSelf-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.
Reductions in number of cigarettes smoked per day26 weeksReductions 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026