Mobile-based Positive Psychological Support for Smoking Cessation Via "Quit to Win" Contest 2021 (QTW 2021)

Smoking Cessation Clinical Trial

Official title:

Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2021: Mobile-based Positive Psychological Support on Smoking Cessation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909320
• Other study ID #: QTW 2021
• Status: Recruiting
• Phase: N/A
• Start date: June 12, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: The University of Hong Kong
• Contact: Man Ping Wang, PhD
• Phone: +852 3917 6636
• Email: mpwang[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to explore 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1094
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• AWARD advice
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

Other:
• Brief leaflet on health warning and smoking cessation
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.
• Referral card
The contents consist of brief information and highlights of existing SC services, contact methods, motivation information, and strong supporting messages or slogans.
• Self-help smoking cessation booklet
The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.

Behavioral:
• Positive psychological support through 3-people group chat using instant messaging apps
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.
• E-messages via SMS
Regular e-messages via SMS at twice per month within 3 months (total 6).

Locations

Country	Name	City	State
China	Hong Kong Council on Smoking and Health (COSH)	Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hong Kong Council on Smoking and Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically validated abstinence	Defined as exhaled CO level <4ppm and saliva cotinine level =30 ng/ml; Note; If participants refuse to have a face-to-face exhaled carbon monoxide test due to the COVID-19 pandemic in Hong Kong. In that case, the outcome will only be validated by a saliva cotinine test device.; If participants use NRT, the outcome will be validated by exhaled carbon monoxide only.	6-month follow-up
Secondary	Biochemically validated abstinence	Defined as exhaled CO level <4ppm and saliva cotinine level =30 ng/ml; Note; If participants refuse to have a face-to-face exhaled carbon monoxide test due to the COVID-19 pandemic in Hong Kong. In that case, the outcome will only be validated by a saliva cotinine test device.; If participants use NRT, the outcome will be validated by exhaled carbon monoxide only.	3-month follow-up
Secondary	Self-reported 7-day point prevalence quit rate	Smokers who did not smoke even a puff in the 7 days preceding the follow-up	3-month follow-up
Secondary	Self-reported 7-day point prevalence quit rate	Smokers who did not smoke even a puff in the 7 days preceding the follow-up	6-month follow-up
Secondary	Self-reported reduction	Defined by at least 50% reduction in baseline daily number of cigarettes	3-month follow-up
Secondary	Self-reported reduction	Defined by at least 50% reduction in baseline daily number of cigarettes	6-month follow-up
Secondary	Self-reported depressive symptoms	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
Secondary	Self-reported depressive symptoms	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
Secondary	Self-reported anxious symptoms	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
Secondary	Self-reported anxious symptoms	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
Secondary	Self-reported use of smoking cessation service	Use of smoking cessation service at 3- and 6- month follow-up	3-month follow-up
Secondary	Self-reported use of smoking cessation service	Use of smoking cessation service at 3- and 6- month follow-up	6-month follow-up
Secondary	Self-rated health	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
Secondary	Self-rated health	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
Secondary	Self-reported happiness	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
Secondary	Self-reported happiness	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
Secondary	Self-reported quit attempts	Number of quit attempts from baseline at 3-month follow-up	3-month follow-up
Secondary	Self-reported quit attempts	Number of quit attempts from baseline at 6-month follow-up	6-month follow-up
Secondary	Self-reported resilience	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
Secondary	Self-reported resilience	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
Secondary	Self-reported optimistic	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
Secondary	Self-reported optimistic	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
Secondary	Self-reported loneliness	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
Secondary	Self-reported loneliness	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
Secondary	Self-reported stress	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
Secondary	Self-reported stress	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
Secondary	Self-reported social support	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
Secondary	Self-reported social support	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
Secondary	Self-reported positive affect	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
Secondary	Self-reported positive affect	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
Secondary	Self-reported negative affect	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
Secondary	Self-reported negative affect	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