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NCT Number: NCT06575673

An Internet-based Dialectical Behaviour Therapy-informed Skills Training for Promoting Smoking Cessation and Improving Psychological Distress of Adult Smokers.

1. To determine the feasibility, acceptability, and preliminary effects of an internet-based DBT-ST for promoting smoking abstinence/reduction and improving psychological distress/emotional regulation in adult smokers 2. To explore the participants' experiences and perceptions (e.g., perceived benefits/weaknesses) towards the proposed intervention

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Key information

Conditions

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Authority, Tai Po, New Territories, Hong Kong

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Hong Kong Chinese aged 18-64 years
  • Had smoked at least one cigarette per day over the previous three months
  • Indicate psychological distress as measured by the Depression, Anxiety, and Stress Scale-21
  • Have an intention to stop smoking
  • Have an electronic device and are willing to receive interventions via the internet

Exclusion criteria

  • Experiencing psychotic disorders/cognitive impairment/communication problems
  • Participating in other smoking cessation programs or related psychosocial interventions

Treatment and study plan

Internet-based dialectical behaviour therapy-informed skills training

Behavioral

Adaptive applications of DBT-ST for smokers with psychological distress

Monthly health education

Behavioral

General health information and sharing sessions

Primary outcomes

  1. Biochemically validated 7-day PPA (an exhaled CO test and a salivary cotinine test)

    Time frame: Baseline, 3-month post-intervention

    Participants who self-reported not smoking within the past seven days will be invited to attend a biochemical verification test of smoking abstinence

  2. Level of psychological distress

    Time frame: Baseline, 3-month post-intervention

    Symptoms of depression, anxiety and stress measured by the Chinese version of Depression, Anxiety, and Stress Scale-21

Secondary outcomes

  1. Self-reported 7-day PPA

    Time frame: Baseline, 3-month post-intervention

    Self-reporting of complete abstinence for at least seven days prior to assessment

  2. Self-reported smoking reduction of at least 50%

    Time frame: 3-month post-intervention

    Participants will report the number of cigarette they consume and the number will be compared to the number at baseline

  3. Quit attempts

    Time frame: Baseline, 3-month post-intervention

    The number of times that the participant engage in a period of intentional abstinence of more than 24 hours in the previous three months

  4. Emotion dysregulation

    Time frame: Baseline, 3-month post-intervention

    Levels of emotion dysregulation measured by the Chinese version of the Difficulties in Emotion Regulation Scale (DERS)

  5. Distress tolerance

    Time frame: Baseline, 3-month post-intervention

    Perceived ability to tolerate emotional distress measured by the Chinese version of the Distress Tolerance Scale (DTS)

Other outcomes

  1. Acceptability

    Time frame: 3-month post-intervention

    Client Satisfaction measured by the 8-item Client Satisfaction Questionnaire-8

  2. Feasibility of the intervention

    Time frame: 3-month post-intervention

    Recruitment rate

  3. Feasibility of the intervention

    Time frame: 3-month post-intervention

    Intervention engagement in terms of time spent on each session and participation rates

  4. Feasibility of the intervention

    Time frame: 3-month post-intervention

    Attrition rates

  5. Semi-structured interview

    Time frame: 3-month post-intervention

    Individual semi-structured interviews will be conducted at post-intervention to explore participants' experiences/perceptions of the internet-based DBT-ST, as well as their comments on the appropriateness/comprehensiveness of the content/frequency of the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Hiu Nam Naomi Wu, Bachelor

CONTACT

[email protected]

39438167

Long Kwan Ho, PhD

CONTACT

[email protected]

39430664

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Effect of an Internet-based Dialectical Behaviour Therapy-informed Skills Training for Promoting Smoking Cessation and Improving Psychological Distress of Smokers: A Pilot Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Sep 22, 2025

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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