- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04909320
Mobile-based Positive Psychological Support for Smoking Cessation Via "Quit to Win" Contest 2021 (QTW 2021)
Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2021: Mobile-based Positive Psychological Support on Smoking Cessation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Smoking is a leading cause of many diseases and deaths globally. Although Hong Kong has a relatively low overall smoking rate of 10.2% (in 2019), health and economic burdens due to smoking are still substantial. The practice of smoking might predispose smokers to COVID-19 infection and poor prognosis. Growing evidence has also suggested that smokers are at higher risk of developing serious respiratory and cardiovascular symptoms in the COVID-19 pandemic than non-smokers. Smoking cessation in the post-COVID-19 era is the key priority to meet the HKSAR Government's target of reducing smoking prevalence to 7.8% by 2025.
Mental health problems are commonly comorbid with smoking and related problems. Our population-based survey amidst the COVID-19 pandemic found current smokers were at higher risk of suffering from anxious symptoms (adjusted OR 1.84 95% CI 1.27, 2.67), depressive symptoms (adjusted OR 2.04 95% CI 1.40, 2.96), and stress symptoms (adjusted β 0.54 95% CI 0.26, 0.82) compared with non-smokers. We also observed mental health burden increased during the COVID-19 pandemic with approximately doubling of the prevalence of anxious symptoms (15.8 vs. 9.3) and depressive symptoms (14.8 vs. 6.3) compared with the pre-COVID-19 pandemic (2017). Mental health can be both precursors and consequences of smoking. Previous studies have suggested that depressive symptoms and low positive affect during and after SC attempts are associated with poor cessation outcomes. This implies that a combined intervention of behavioral and psychological SC intervention is needed, particularly under the circumstance of worsening mental health problems.
Therefore, our study aims to test the effectiveness of a combined intervention using brief cessation advice and personalized chat-based positive psychological support compared with the control group on current smokers who join the Quit to Win Contest.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Man Ping Wang, PhD
- Phone Number: +852 3917 6636
- Email: mpwang@hku.hk
Study Contact Backup
- Name: Ziqiu Guo, MMed
- Phone Number: +852 3917 6605
- Email: zqguo@hku.hk
Study Locations
-
-
Hong Kong
-
Hong Kong, Hong Kong, China, 852
- Recruiting
- Hong Kong Council on Smoking and Health (COSH)
-
Contact:
- Fung Wong
- Phone Number: +852 2180 5186
-
Principal Investigator:
- Man Ping Kelvin Wang, PhD
-
Sub-Investigator:
- Tai Hing Lam, MD, MSc
-
Sub-Investigator:
- Ho Cheung William Li, PhD
-
Sub-Investigator:
- Yee Tak Derek Cheung, PhD
-
Sub-Investigator:
- Xue Weng, PhD
-
Sub-Investigator:
- Ziqiu Guo, MMed
-
Sub-Investigator:
- Yuen Kwan Agnes Lai, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hong Kong residents aged 18 or above
- Smoke at least 1 tobacco stick (includes HTP) per day or use e-cigarette daily in the past 3-month
- Able to communicate in Chinese
- Saliva cotinine 30 ng/ml or above
- Intent to quit/reduce smoking
- Able to use the instant messaging tool (e.g., WhatsApp, WeChat) for communication
Exclusion Criteria:
- Smokers who have communication barrier (either physically or cognitively)
- Smokers who are currently participating in other SC programmes or services
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
|
Ask about smoking history; Warn about the high risk; Advise to quit; Refer smokers to smoking cessation services (with a referral card); Do it again
The contents of the leaflet include (1) highlights of the absolute risk of death due to smoking; (2) the whole list of diseases caused by active and second-hand smoking; (3) ten horrible pictorial warnings of health consequences of smoking and second-hand smoking in one page to maximize the impacts; (4) benefits of SC and (5) simple messages to encourage participants to quit smoking and remind them to call the Department of Health SC hotline 183 3183.
The contents consist of brief information and highlights of existing SC services, contact methods, motivation information, and strong supporting messages or slogans.
The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.
Each IM chat group will consist of a trained SC counselor (HKU staff), a peer supporter (former smoker), and a participant (smoker).
The 3-month group chat-based intervention will consist of regular messages and real-time support through group chat.
Regular messages will generally include goal setting, health warnings, abstinence support, positive psychological exercises, and encouragement and will be delivered in a tapering style.
During the real-time chatting, SC counsellors and peer supporters will provide real-time chat-based support, and peer supporters will share their quitting experience as appropriate.
|
|
Active Comparator: Control group
|
Ask about smoking history; Warn about the high risk; Advise to quit; Refer smokers to smoking cessation services (with a referral card); Do it again
The contents of the leaflet include (1) highlights of the absolute risk of death due to smoking; (2) the whole list of diseases caused by active and second-hand smoking; (3) ten horrible pictorial warnings of health consequences of smoking and second-hand smoking in one page to maximize the impacts; (4) benefits of SC and (5) simple messages to encourage participants to quit smoking and remind them to call the Department of Health SC hotline 183 3183.
The contents consist of brief information and highlights of existing SC services, contact methods, motivation information, and strong supporting messages or slogans.
The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.
Regular e-messages via SMS at twice per month within 3 months (total 6).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biochemically validated abstinence
Time Frame: 6-month follow-up
|
Defined as exhaled CO level <4ppm and saliva cotinine level ≤30 ng/ml Note
|
6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biochemically validated abstinence
Time Frame: 3-month follow-up
|
Defined as exhaled CO level <4ppm and saliva cotinine level ≤30 ng/ml Note
|
3-month follow-up
|
|
Self-reported 7-day point prevalence quit rate
Time Frame: 3-month follow-up
|
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
|
3-month follow-up
|
|
Self-reported 7-day point prevalence quit rate
Time Frame: 6-month follow-up
|
Smokers who did not smoke even a puff in the 7 days preceding the follow-up
|
6-month follow-up
|
|
Self-reported reduction
Time Frame: 3-month follow-up
|
Defined by at least 50% reduction in baseline daily number of cigarettes
|
3-month follow-up
|
|
Self-reported reduction
Time Frame: 6-month follow-up
|
Defined by at least 50% reduction in baseline daily number of cigarettes
|
6-month follow-up
|
|
Self-reported depressive symptoms
Time Frame: 3-month follow-up
|
Measured by Patient Health Questionnaire-2 (PHQ-2).
PHQ-2 ranges from 0-6, a higher score indicates a severer depressive symptom.
|
3-month follow-up
|
|
Self-reported depressive symptoms
Time Frame: 6-month follow-up
|
Measured by Patient Health Questionnaire-2 (PHQ-2).
PHQ-2 ranges from 0-6, a higher score indicates a severer depressive symptom.
|
6-month follow-up
|
|
Self-reported anxious symptoms
Time Frame: 6-month follow-up
|
Measured by Generalized Anxiety Disorder-2 (GAD-2).
GAD-2 ranges from 0-6, a higher score indicates a severer anxious symptom.
|
6-month follow-up
|
|
Self-reported anxious symptoms
Time Frame: 3-month follow-up
|
Measured by Generalized Anxiety Disorder-2 (GAD-2).
GAD-2 ranges from 0-6, a higher score indicates a severer anxious symptom.
|
3-month follow-up
|
|
Self-reported use of smoking cessation service
Time Frame: 3-month follow-up
|
Use of smoking cessation service at 3- and 6- month follow-up
|
3-month follow-up
|
|
Self-reported use of smoking cessation service
Time Frame: 6-month follow-up
|
Use of smoking cessation service at 3- and 6- month follow-up
|
6-month follow-up
|
|
Self-rated health
Time Frame: 3-month follow-up
|
Self-rated health will be measured as a single item with the response items "excellent", "very good", "good", "fair", or "poor".
|
3-month follow-up
|
|
Self-rated health
Time Frame: 6-month follow-up
|
Self-rated health will be measured as a single item with the response items "excellent", "very good", "good", "fair", or "poor".
|
6-month follow-up
|
|
Self-reported happiness
Time Frame: 3-month follow-up
|
A single item will measure self-reported happiness with an answer on an 11-point scale (0-10).
A higher score indicates a higher level of happiness.
|
3-month follow-up
|
|
Self-reported happiness
Time Frame: 6-month follow-up
|
A single item will measure self-reported happiness with an answer on an 11-point scale (0-10).
A higher score indicates a higher level of happiness.
|
6-month follow-up
|
|
Self-reported quit attempts
Time Frame: 3-month follow-up
|
Number of quit attempts from baseline at 3-month follow-up
|
3-month follow-up
|
|
Self-reported quit attempts
Time Frame: 6-month follow-up
|
Number of quit attempts from baseline at 6-month follow-up
|
6-month follow-up
|
|
Self-reported resilience
Time Frame: 3-month follow-up
|
A single item will measure self-reported resilience with an answer on an 11-point scale (0-10).
A higher score indicates a higher level of resilience.
|
3-month follow-up
|
|
Self-reported resilience
Time Frame: 6-month follow-up
|
A single item will measure self-reported resilience with an answer on an 11-point scale (0-10).
A higher score indicates a higher level of resilience.
|
6-month follow-up
|
|
Self-reported optimistic
Time Frame: 3-month follow-up
|
A single item will measure self-reported optimistic with an answer on an 11-point scale (0-10).
A higher score indicates a higher level of optimistic.
|
3-month follow-up
|
|
Self-reported optimistic
Time Frame: 6-month follow-up
|
A single item will measure self-reported optimistic with an answer on an 11-point scale (0-10).
A higher score indicates a higher level of optimistic.
|
6-month follow-up
|
|
Self-reported loneliness
Time Frame: 3-month follow-up
|
A single item will measure self-reported loneliness with an answer on an 11-point scale (0-10).
A higher score indicates a higher level of loneliness.
|
3-month follow-up
|
|
Self-reported loneliness
Time Frame: 6-month follow-up
|
A single item will measure self-reported loneliness with an answer on an 11-point scale (0-10).
A higher score indicates a higher level of loneliness.
|
6-month follow-up
|
|
Self-reported stress
Time Frame: 6-month follow-up
|
A single item will measure self-reported stress with an answer on an 11-point scale (0-10).
A higher score indicates a higher level of stress.
|
6-month follow-up
|
|
Self-reported stress
Time Frame: 3-month follow-up
|
A single item will measure self-reported stress with an answer on an 11-point scale (0-10).
A higher score indicates a higher level of stress.
|
3-month follow-up
|
|
Self-reported social support
Time Frame: 3-month follow-up
|
A single item will measure self-reported social support with an answer on an 11-point scale (0-10).
A higher score indicates a higher level of social support.
|
3-month follow-up
|
|
Self-reported social support
Time Frame: 6-month follow-up
|
A single item will measure self-reported social support with an answer on an 11-point scale (0-10).
A higher score indicates a higher level of social support.
|
6-month follow-up
|
|
Self-reported positive affect
Time Frame: 3-month follow-up
|
The subscale of the Chinese version International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) will measure self-reported positive affect.
The I-PANAS-SF uses a 5-point scale, a higher score indicates a higher level of self-reported positive affect.
|
3-month follow-up
|
|
Self-reported positive affect
Time Frame: 6-month follow-up
|
The subscale of the Chinese version International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) will measure self-reported positive affect.
The I-PANAS-SF uses a 5-point scale, a higher score indicates a higher level of self-reported positive affect.
|
6-month follow-up
|
|
Self-reported negative affect
Time Frame: 6-month follow-up
|
The subscale of the Chinese version International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) will measure self-reported negative affect.
The I-PANAS-SF uses a 5-point scale, a higher score indicates a higher level of self-reported negative affect.
|
6-month follow-up
|
|
Self-reported negative affect
Time Frame: 3-month follow-up
|
The subscale of the Chinese version International Positive and Negative Affect Schedule Short Form (I-PANAS-SF) will measure self-reported negative affect.
The I-PANAS-SF uses a 5-point scale, a higher score indicates a higher level of self-reported negative affect.
|
3-month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- QTW 2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking Cessation
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
National University of SingaporeRecruitingSmoking &Amp; Tobacco CessationSingapore
-
Nabi BiopharmaceuticalsNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco CessationUnited States
-
Claremont Graduate UniversityNational Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, CigaretteUnited States
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Heidelberg UniversityPfizerTerminatedSmoking | Smoking Cessation | Tobacco Use CessationGermany
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedSmoking &Amp; Tobacco CessationUnited States
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Sultan Qaboos UniversityCompletedSmoking Cessation | Tobacco Use Cessation | Smoking PreventionOman
-
University of VermontMayo Clinic; Alaska Native Tribal Health ConsortiumTerminatedSmoking | Smoking CessationUnited States
Clinical Trials on AWARD advice
-
The University of Hong KongHong Kong Council on Smoking and HealthActive, not recruiting
-
The University of Hong KongCompleted
-
The University of Hong KongCompleted
-
The University of Hong KongHong Kong Council on Smoking and HealthCompleted
-
The University of Hong KongHong Kong Council on Smoking and HealthActive, not recruiting
-
The University of Hong KongHong Kong Council on Smoking and HealthCompletedSmoking CessationHong Kong
-
The University of Hong KongFood and Health Bureau, Hong KongCompletedSmoking Cessation | Tobacco Use CessationHong Kong
-
The University of Hong KongActive, not recruiting
-
Chinese University of Hong KongRecruiting