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

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

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

Study Overview

• Status: Recruiting
• Conditions: Smoking
• Intervention / Treatment: Behavioral: Monthly health education; Behavioral: Internet-based dialectical behaviour therapy-informed skills training

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Long Kwan Ho, PhD; Phone Number: 39430664; Email: longkwanho@cuhk.edu.hk
• Study Contact Backup: Name: Hiu Nam Naomi Wu, Bachelor; Phone Number: 39438167; Email: hiunamnaomiwu@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Not yet recruiting
    • Hospital Authority
    • Contact: Long Kwan Ho; Phone Number: 852-3943-0664; Email: longkwanho@cuhk.edu.hk
    • Principal Investigator: Long Kwan Ho, Phd
  • New Territories
    • Tai Po, New Territories, Hong Kong
      • Recruiting
      • Hospital Authority
      • Contact: Long Kwan Ho; Phone Number: 39430664; Email: longkwanho@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Adaptive applications of DBT-ST for smokers with psychological distress
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; General health information and sharing sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported 7-day PPA	Self-reporting of complete abstinence for at least seven days prior to assessment	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	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	Baseline, 3-month post-intervention
Emotion dysregulation	Levels of emotion dysregulation measured by the Chinese version of the Difficulties in Emotion Regulation Scale (DERS)	Baseline, 3-month post-intervention
Distress tolerance	Perceived ability to tolerate emotional distress measured by the Chinese version of the Distress Tolerance Scale (DTS)	Baseline, 3-month post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Client Satisfaction measured by the 8-item Client Satisfaction Questionnaire-8	3-month post-intervention
Feasibility of the intervention	Recruitment rate	3-month post-intervention
Feasibility of the intervention	Intervention engagement in terms of time spent on each session and participation rates	3-month post-intervention
Feasibility of the intervention	Attrition rates	3-month post-intervention
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.	3-month post-intervention

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Smoking; Psychological distress; Internet-based intervention; Adult smokers; Skills training; Dialectical behaviour therapy
• Additional Relevant MeSH Terms: Behavior; Smoking
• Other Study ID Numbers: 07210048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No