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Completed

NCT Number: NCT04421170

Efficacy of Smartphone App for Smoking Cessation in China

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

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yanhui Liao

Hangzhou, Zhejiang, 310016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

smartphone app for smoking cessation

Behavioral

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

Primary outcomes

  1. Biologically verified continuously smoking abstinence at week 26

    Time frame: 26 weeks

    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).

Secondary outcomes

  1. 7-day point prevalence smoking abstinence

    Time frame: 26 weeks

    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.

  2. Self-reported continuous smoking abstinence

    Time frame: 26 weeks

    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.

  3. Reductions in number of cigarettes smoked per day

    Time frame: 26 weeks

    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.

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2020
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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