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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: AWARD advice
* Other: Brief leaflet on health warning and smoking cessation
* Other: Referral card
* Other: Self-help smoking cessation booklet
* Behavioral: Positive psychological support through 3-people group chat using instant messaging apps
* Behavioral: E-messages via SMS


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Behavioral: AWARD advice<br>* 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<br>Other: Brief leaflet on health warning and smoking cessation<br>* 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.<br>Other: Referral card<br>* The contents consist of brief information and highlights of existing SC services, contact methods, motivation information, and strong supporting messages or slogans.<br>Other: Self-help smoking cessation booklet<br>* The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.<br>Behavioral: Positive psychological support through 3-people group chat using instant messaging apps<br>* 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.<br>|
| Active Comparator: Control group<br> | Behavioral: AWARD advice<br>* 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<br>Other: Brief leaflet on health warning and smoking cessation<br>* 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.<br>Other: Referral card<br>* The contents consist of brief information and highlights of existing SC services, contact methods, motivation information, and strong supporting messages or slogans.<br>Other: Self-help smoking cessation booklet<br>* The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.<br>Behavioral: E-messages via SMS<br>* Regular e-messages via SMS at twice per month within 3 months (total 6).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Self-reported reduction | Defined by at least 50% reduction in baseline daily number of cigarettes | 3-month follow-up | 
| Self-reported reduction | Defined by at least 50% reduction in baseline daily number of cigarettes | 6-month follow-up | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Self-reported use of smoking cessation service | Use of smoking cessation service at 3- and 6- month follow-up | 3-month follow-up | 
| Self-reported use of smoking cessation service | Use of smoking cessation service at 3- and 6- month follow-up | 6-month follow-up | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Self-reported quit attempts | Number of quit attempts from baseline at 3-month follow-up | 3-month follow-up | 
| Self-reported quit attempts | Number of quit attempts from baseline at 6-month follow-up | 6-month follow-up | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
smoking cessation, positive psychological support, mobile health, peer supporter