An Internet-based Dialectical Behaviour Therapy-informed Skills Training for Reducing Alcohol Consumption and Improving Psychological Distress of Adult Smokers.
NCT Number: NCT06575673
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking
Interventions: BEHAVIORAL: Internet-based dialectical behaviour therapy-informed skills training|BEHAVIORAL: Monthly health education
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09
Completion Date: 2025-12
Locations: Hospital Authority, Hong Kong, Hong Kong

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

Primary Outcome Measures: 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: 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: 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