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Efficacy of Smartphone App for Smoking Cessation in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04421170
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
Yanhui Liao, Sir Run Run Shaw Hospital

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.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Smartphone App-based Smoking Cessation Behavioral: smartphone app for smoking cessation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Cognitive Behavioral Therapy-based Smartphone App for Smoking Cessation in China: a Study Protocol of a Randomized Controlled Trial
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
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.
Behavioral: smartphone app for smoking cessation
Paticipants will receive 12-week app-based smoking cessation intervention with follow-up to 26 weeks.

No Intervention: Control group
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04421170


Contacts
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Contact: Yanhui Liao, MD 8615116225099 tangliaoyanhui@163.com

Locations
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China, Zhejiang
Yanhui Liao Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Yanhui Liao, MD    8615116225099    liaoyanhui@zju.edu.cn   
Sponsors and Collaborators
Sir Run Run Shaw Hospital
Investigators
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Principal Investigator: Yanhui Liao, MD Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yanhui Liao, Principal Investigator, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT04421170    
Other Study ID Numbers: 20200129-33
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD, all IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Starting 1 month after publication.
Access Criteria: Yanhui Liao will review requests and criteria for reviewing requests

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No