Efficacy of Smartphone App for Smoking Cessation in China

Sponsor

Sir Run Run Shaw Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04421170

Collaborator

(none)

1,200

Enrollment

Location

Arms

24.1

Anticipated Duration (Months)

49.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Feb 23, 2021

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Biologically verified continuously smoking abstinence at week 26 [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

7-day point prevalence smoking abstinence [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.
Self-reported continuous smoking abstinence [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.
Reductions in number of cigarettes smoked per day [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yanhui Liao	Hangzhou	Zhejiang	China	310016

Sponsors and Collaborators

Sir Run Run Shaw Hospital

Investigators

Principal Investigator: Yanhui Liao, MD, Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yanhui Liao, Principal Investigator, Sir Run Run Shaw Hospital

ClinicalTrials.gov Identifier:

NCT04421170

Other Study ID Numbers:

20200129-33

First Posted:

Jun 9, 2020

Last Update Posted:

Jan 24, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 24, 2022