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

NCT06575673 | Recruiting

• 1 other identifier: 07210048
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

1. 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. 2.To explore the participants' experiences and perceptions (e.g., perceived benefits/weaknesses) towards the proposed intervention

Conditions

Smoking

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Baseline, 3-month post-intervention

Secondary Outcomes (5)

• Self-reported 7-day PPA

  Baseline, 3-month post-intervention

• Self-reported smoking reduction of at least 50%

  3-month post-intervention

• Quit attempts

  Baseline, 3-month post-intervention

• Emotion dysregulation

  Baseline, 3-month post-intervention

• Distress tolerance

  Baseline, 3-month post-intervention

Other Outcomes (5)

• Acceptability

  3-month post-intervention

• Feasibility of the intervention

  3-month post-intervention

• Feasibility of the intervention

  3-month post-intervention

Study Arms (2)

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)

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).

Behavioral: Monthly health education

Interventions

Internet-based dialectical behaviour therapy-informed skills training BEHAVIORAL

Adaptive applications of DBT-ST for smokers with psychological distress

DBT-ST group

Monthly health education BEHAVIORAL

General health information and sharing sessions

TAU

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Hospital Authority

Tai Po, New Territories, Hong Kong

RECRUITING

Hospital Authority

Hong Kong, Hong Kong

NOT YET RECRUITING

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Long Kwan Ho, PhD

CONTACT

39430664; longkwanho@cuhk.edu.hk

Hiu Nam Naomi Wu, Bachelor

CONTACT

39438167; hiunamnaomiwu@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 28, 2024
• Study Start: September 4, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

HK (2)