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Completed

NCT Number: NCT04409496

Chat-based Support for Preventing Smoking Relapse

This pilot trial aims to evaluate the effectiveness of chat-based instant messaging support in preventing smoking relapse in recent tobacco abstainers.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation

Hong Kong

About this study

Smoking cessation is one of the most cost-effective health interventions, which can add up to 10 years of life expectancy (Jha et al., 2013). However, it is very difficult to quit smoking because of the addictive effect of nicotine presents in tobacco products, and smokers typically make multiple attempts before successfully quit smoking. Providing evidence-based treatment could substantially increase the chance of successful quitting.

The Coronavirus Disease 2019 (COVID-19) provided new opportunities and challenges in promoting smoking cessation. A growing literature has shown that smoking is linked to poor progression of COVID-19 (Patanavanich & Glantz, 2020), which can be a new warning for motivating smokers to quit smoking. However, social distancing measures and increased stress and anxiety related to fear of contracting COVID-19 may increase the risk of smoking relapse in people who recently quit smoking (Patwardhan, 2020). There are also misinformation or unproven claims that smoking can protect against COVID-19. The social distancing measures also become a barrier for smokers who are interested in quitting to receive treatment from smoking cessation clinics. Therefore, implementing new interventions that can address the challenges in the context of the COVID-19 pandemic is needed.

Advance in mobile technologies provides a new avenue for delivering smoking cessation support. A qualitative interview of 21 current smokers in Hong Kong has found that mobile instant messaging app (e.g., WhatsApp) is an acceptable and feasible platform for providing chat support for smoking cessation (Luk et al., 2019). Chat-based support allows a registered nurse or trained counsellor to interact with a smoker individually through mobile instant messaging apps (e.g., WhatsApp and WeChat) and provide real-time, continuous, and personalized smoking cessation information and advice. A randomised trial of 1185 smokers found that the chat-based intervention integrated with brief intervention was effective in increasing smoking cessation (Wang et al., 2019). The trial also provided initial evidence that the intervention can be delivered as a stand-alone treatment or in combination with use of existing cessation treatment, to increase the chance of successful quitting. This study aims to adapt the chat intervention for smoking relapse prevention and evaluate its feasibility and effectiveness in recent tobacco abstainers enrolled in a clinic-based smoking cessation service in Hong Kong.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hong Kong residents aged 18 years or older
  • Enrolled in a smoking cessation programme under Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
  • Daily tobacco use before service intake
  • Not using any tobacco product for 3 to 30 days
  • Own a mobile phone with a mobile instant messaging app (WhatsApp or WeChat) installed
  • Able to communicate in Chinese (Cantonese or Mandarin)

Exclusion criteria

  • Subjects with communication barriers owing to physical or cognitive conditions will be excluded.

Treatment and study plan

Chat-based instant messaging support

Behavioral

Subjects will receive personalised instant messaging support for 12 weeks after baseline, address the five problems that contributed to smoking relapse:

(1) lack of support for cessation, (2) negative mood or depression, (3) strong or prolonged withdrawal symptoms, (4) weight gain, and (5) smoking lapses. Updated information about the negative effect of smoking on risk of COVID-19 infection and prognosis will also be delivered.

SMS message support

Behavioral

Subjects will receive regular SMS on generic smoking cessation for 3 months.

Self-help booklet

Behavioral

Subjects will receive a standard self-help booklet on smoking relapse prevention.

Primary outcomes

  1. Biochemically-validated tobacco abstinence

    Time frame: Assessed at 6 months after randomisation

    Defined by an exhaled carbon monoxide level of 3 parts per million or below

Secondary outcomes

  1. Self-reported 6-month prolonged tobacco abstinence

    Time frame: Assessed at 6 months after randomisation

    Not more than five lapses permitted for 6 months after baseline

  2. Self-reported 7-day point-prevalence tobacco abstinence

    Time frame: Assessed at 3 months after randomisation

    Being completely smoke-free in the past 7 days

  3. Self-reported 7-day point-prevalence tobacco abstinence

    Time frame: Assessed at 6 months after randomisation

    Being completely smoke-free in the past 7 days

  4. Self-reported relapse rate

    Time frame: Assessed at 3 months after randomisation

    Defined as use of tobacco products for 7 consecutive days or longer

  5. Self-reported relapse rate

    Time frame: Assessed at 6 months after randomisation

    Defined as use of tobacco products for 7 consecutive days or longer

Other outcomes

  1. Change in self-efficacy to quit smoking

    Time frame: Assessed at 3 months after randomisation

    Assessed by the Chinese version of the Smoking Self-efficacy Questionnaire (SEQ-12), which contains 12 Likert items ranging from 1 (not certain at all) to 5 (very certain) with higher scores indicating greater perceived confidence in resisting smoking.

  2. Change in self-efficacy to quit smoking

    Time frame: Assessed at 6 months after randomisation

    Assessed by the Chinese version of the Smoking Self-efficacy Questionnaire (SEQ-12), which contains 12 Likert items ranging from 1 (not certain at all) to 5 (very certain) with higher scores indicating greater perceived confidence in resisting smoking.

  3. Nicotine withdrawal

    Time frame: Assessed at 3 months after randomisation

    Assessed by the Chinese verion of the Minnesota Nicotine Withdrawal Scale (MNWS), which contains 9 Likert items ranging from 0 (not at all) to 4 (very severe) with higher scores indicating greater nicotine withdrawal.

  4. Nicotine withdrawal

    Time frame: Assessed at 6 months after randomisation

    Assessed by the Chinese verion of the Minnesota Nicotine Withdrawal Scale (MNWS), which contains 9 Likert items ranging from 0 (not at all) to 4 (very severe) with higher scores indicating greater nicotine withdrawal.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Chat-based Instant Messaging Support for Preventing Smoking Relapse in the Context of COVID-19 Outbreak: a Pilot Randomised Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2020
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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