Efficacy of Smartphone App for Smoking Cessation in China

NCT04421170 | Completed DMC

• 1 other identifier: 20200129-33
• Study Type: interventional
• Target: 1,289
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking; Smartphone App-based Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 7-day point prevalence smoking abstinence

  26 weeks

• Self-reported continuous smoking abstinence

  26 weeks

• Reductions in number of cigarettes smoked per day

  26 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

smartphone app for smoking cessation BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cigarette smokers (smoked more than 100 cigarettes in their lifetime, and currently smoke five or more cigarettes a day)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Yanhui Liao

Hangzhou, Zhejiang, 310016, China

Location

Related Publications (2)

• Chen S, Tang J, Wu C, Zhang G, Zhang J, Liao Y. Preliminary Efficacy of a Cognitive Behavioral Therapy-Based Smartphone App for Smoking Cessation in China: Randomized Controlled Pilot Trial. JMIR Form Res. 2024 Mar 18;8:e48050. doi: 10.2196/48050.

  PMID: 38498030 DERIVED

• Liao Y, Tang J. Efficacy of cognitive behavioural therapy-based smartphone app for smoking cessation in China: a study protocol of a randomised controlled trial. BMJ Open. 2021 Jan 13;11(1):e041985. doi: 10.1136/bmjopen-2020-041985.

  PMID: 33441359 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Yanhui Liao, MD

  Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: February 23, 2021
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 1 month after publication.
• Access Criteria: Yanhui Liao will review requests and criteria for reviewing requests

Locations

CN (1)