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临床试验/NCT06575673
NCT06575673招募中不适用

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

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Biochemically validated 7-day PPA (an exhaled CO test and a salivary cotinine test)

研究概览

简要总结

  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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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)

干预措施: Internet-based dialectical behaviour therapy-informed skills training (Behavioral)

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).

干预措施: Monthly health education (Behavioral)

结局指标

主要结局

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

时间窗: 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

时间窗: Baseline, 3-month post-intervention

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

次要结局

  • Quit attempts(Baseline, 3-month post-intervention)
  • Distress tolerance(Baseline, 3-month post-intervention)
  • Self-reported smoking reduction of at least 50%(3-month post-intervention)
  • Emotion dysregulation(Baseline, 3-month post-intervention)
  • Self-reported 7-day PPA(Baseline, 3-month post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ho Long Kwan

Assistant Professor

Chinese University of Hong Kong

研究点 (2)

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