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RecruitingNCT06575673Updated Sep 22, 2025

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

An interventional study of Internet-based dialectical behaviour therapy-informed skills training and Monthly health education in Smoking, sponsored by Chinese University of Hong Kong. Recruiting at 2 sites in Hong Kong. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

  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
02

Conditions studied

  • Smoking

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Keywords

  • Dialectical behaviour therapy
  • Skills training
  • Internet-based intervention
  • Psychological distress
  • Adult smokers
  • Smoking
03

In context

Smoking

268 studies on the registry are indexed under Smoking; 136 are open to participants now.

This study's planned enrollment of 60 is below the median of 120 across 211 interventional studies indexed under Smoking.

Browse Smoking studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Experiencing psychotic disorders/cognitive impairment/communication problems
  • Participating in other smoking cessation programs or related psychosocial interventions
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    DBT-ST group

    Participants in the intervention group will receive the DBT-ST by means of a free video-communication app. Over the next 14 weeks from the baseline, participants will receive two individual sessions (30-45 mins) and 12 group therapy sessions (120-minute)

    Behavioral: Internet-based dialectical behaviour therapy-informed skills training

  • Other
    TAU

    Participants in the control group will receive a smoking cessation booklet published by the Hong Kong Council on Smoking and Health that provided information on the negative health consequences of smoking, reasons to quit, strategies for quitting, smoking cessation services available in Hong Kong, and a public Quitline number (usual care). Participants will also receive a monthly health education for three months that provides general health information and sharing sessions, which is one of the routine care for smokers during the first 3-4 months after they seek help for smoking problem (waiting period for further intervention).

    Behavioral: Monthly health education

Interventions

  • BehavioralInternet-based dialectical behaviour therapy-informed skills training

    Adaptive applications of DBT-ST for smokers with psychological distress

  • BehavioralMonthly health education

    General health information and sharing sessions

06

What researchers measure

Primary outcomes

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

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

    Time frame: Baseline, 3-month post-intervention

  2. Level of psychological distress

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

    Time frame: Baseline, 3-month post-intervention

Secondary outcomes

  1. Self-reported 7-day PPA

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

    Time frame: Baseline, 3-month post-intervention

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

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

    Time frame: 3-month post-intervention

  3. Quit attempts

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

    Time frame: Baseline, 3-month post-intervention

  4. Emotion dysregulation

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

    Time frame: Baseline, 3-month post-intervention

  5. Distress tolerance

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

    Time frame: Baseline, 3-month post-intervention

Other outcomes

  1. Acceptability

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

    Time frame: 3-month post-intervention

  2. Feasibility of the intervention

    Recruitment rate

    Time frame: 3-month post-intervention

  3. Feasibility of the intervention

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

    Time frame: 3-month post-intervention

  4. Feasibility of the intervention

    Attrition rates

    Time frame: 3-month post-intervention

  5. Semi-structured interview

    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.

    Time frame: 3-month post-intervention

07

Study locations

1 of 2 sites recruiting
  • Hospital Authority
    Tai Po, New Territories, Hong Kong
    Recruiting
  • Hospital Authority
    Hong Kong, Hong Kong
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06575673
Lead sponsor
Chinese University of Hong Kong
Responsible party
Ho Long Kwan (Assistant Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Aug 28, 2024
Start date
Sep 4, 2024
Primary completion
Sep 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Sep 22, 2025

Study contacts

Long Kwan Ho, PhD
Contact
longkwanho@cuhk.edu.hk
39430664
Hiu Nam Naomi Wu, Bachelor
Contact
hiunamnaomiwu@cuhk.edu.hk
39438167

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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