Efficacy of Smartphone App for Smoking Cessation in China

NCT ID: NCT04421170

Last Updated: 2023-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2023-04-15

Brief Summary

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

Detailed Description

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Conditions

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Cigarette Smoking Smartphone App-based Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

smartphone app for smoking cessation

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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smartphone app for smoking cessation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Run Run Shaw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yanhui Liao

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanhui Liao, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Yanhui Liao

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 38498030 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33441359 (View on PubMed)

Other Identifiers

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20200129-33

Identifier Type: -

Identifier Source: org_study_id

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