SmokingNCT06575673
An Internet-based Dialectical Behaviour Therapy-informed Skills Training for Promoting Smoking Cessation and Improving Psychological Distress of Adult Smokers.
A study testing Internet-based dialectical behaviour therapy-informed skills training and Monthly health education in people with Smoking, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Internet-based dialectical behaviour therapy-informed skills training and Monthly health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesHong Kong
- Study dates
- 4 Sep 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Experiencing psychotic disorders/cognitive impairment/communication problems
- Participating in other smoking cessation programs or related psychosocial interventions
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Not yet recruiting
Hospital Authority
Hong Kong
Long Kwan Ho, 852-3943-0664, longkwanho@cuhk.edu.hk
Long Kwan Ho, Phd
- Recruiting
Hospital Authority
Tai Po, New Territories
Long Kwan Ho, 39430664, longkwanho@cuhk.edu.hk
About this study
Official 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
- 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
- To explore the participants' experiences and perceptions (e.g., perceived benefits/weaknesses) towards the proposed intervention
- Conditions
- Smoking
- Being tested
- Internet-based dialectical behaviour therapy-informed skills training, Monthly health education
- Keywords
- Dialectical behaviour therapy, Skills training, Internet-based intervention, Psychological distress, Adult smokers, Smoking
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based dialectical behaviour therapy-informed skills trainingBehavioural
Adaptive applications of DBT-ST for smokers with psychological distress
Monthly health educationBehavioural
General health information and sharing sessions
| Study group | Role | What they receive |
|---|---|---|
| DBT-ST group | Experimental | 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) Receives: Behavioral: Internet-based dialectical behaviour therapy-informed skills training |
| TAU | Other | 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). Receives: Behavioral: Monthly health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 3-month post-intervention
Level of psychological distress
Symptoms of depression, anxiety and stress measured by the Chinese version of Depression, Anxiety, and Stress Scale-21
Measured: Baseline, 3-month post-intervention
Secondary outcomes (5)
Self-reported 7-day PPA
Self-reporting of complete abstinence for at least seven days prior to assessment
Measured: Baseline, 3-month post-intervention
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
Measured: 3-month post-intervention
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
Measured: Baseline, 3-month post-intervention
Emotion dysregulation
Levels of emotion dysregulation measured by the Chinese version of the Difficulties in Emotion Regulation Scale (DERS)
Measured: Baseline, 3-month post-intervention
Distress tolerance
Perceived ability to tolerate emotional distress measured by the Chinese version of the Distress Tolerance Scale (DTS)
Measured: Baseline, 3-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start4 Sep 2024
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Long Kwan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575673
- Sponsor's protocol ID
- 07210048
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06575673
- Acronym / sponsor ID
- 07210048
- Conditions
- Smoking
- Keywords
- Dialectical behaviour therapy, Skills training, Internet-based intervention, Psychological distress, Adult smokers, Smoking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- To explore the participants' experiences and perceptions (e.g., perceived benefits/weaknesses) towards the proposed intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBT-ST group | Experimental | Behavioral: Internet-based dialectical behaviour therapy-informed skills trainingParticipants 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) |
| TAU | Other | Behavioral: Monthly health educationParticipants 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). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Experiencing psychotic disorders/cognitive impairment/communication problems
- Participating in other smoking cessation programs or related psychosocial interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based dialectical behaviour therapy-informed skills trainingAdaptive applications of DBT-ST for smokers with psychological distress | Behavioural | DBT-ST group |
| Monthly health educationGeneral health information and sharing sessions | Behavioural | TAU |
Primary outcome
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
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
5 secondary outcomes
Self-reported 7-day PPA
Time frame: Baseline, 3-month post-intervention
Self-reported smoking reduction of at least 50%
Time frame: 3-month post-intervention
Quit attempts
Time frame: Baseline, 3-month post-intervention
Emotion dysregulation
Time frame: Baseline, 3-month post-intervention
Distress tolerance
Time frame: Baseline, 3-month post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based dialectical behaviour therapy-informed skills training and Monthly health education in people with Smoking, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Long Kwan Ho, PhD (39430664, longkwanho@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically validated 7-day PPA (an exhaled CO test and a salivary cotinine test) (time frame: Baseline, 3-month post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.