跳至主要内容
临床试验/NCT05045326
NCT05045326招募中不适用

Effectiveness of a Smoking Cessation Intervention in a Mental Health Day Hospital

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
Tobacco use changes from baseline to post-intervention

研究概览

简要总结

Background: Nicotine contained in tobacco is highly addictive and tobacco use is a major risk factor for cardiovascular and respiratory diseases. Every year, more than 8 million people die from tobacco use.

Smoking-related mortality is significantly higher in people with serious mental illness. Is estimated that half of all deaths among individuals with mental illnesses are attributable to tobacco use. People with serious mental illness have greater daily tobacco consumption, nicotine dependence, and smoking relapse. While significant progress has been made in reducing tobacco use within the general population, rates of tobacco use remain high among individuals with mental illness. Smoking cessation often requires numerous attempts by these people. Thus, smokers with mental health illnesses may find it more difficult to quit, although highly motivated to quit.

Smoking cessation during hospitalization (total or partial) is cost-effective, as it reduces hospital readmissions, and mortality, and improves smokers' quality of life. Available quitting aids are both safe and effective in supporting cessation in tobacco users with mental illness and stopping smoking is associated with an improvement in mental health.

The investigators aimed to evaluate the feasibility and efficacy of adding an intensive smoking intervention to the usual treatment for patients with psychiatric disorders attending a day hospital of a tertiary hospital.

详细描述

The investigators will perform a quasi-experimental, longitudinal, and prospective study in the mental health day hospital of the Hospital Clinic of Barcelona.

Adults attending the day hospital and willing to participate, under informed consent, will be invited to participate. Consecutive eligible individuals will be recruited and will be assigned to two groups, the control group, and the experimental group. Initially, patients will be recruited for the control group, once the control group is completed the experimental group will begin.

An assessment will be conducted at baseline (admission) and in the discharge. Sociodemographic and clinical data will be obtained.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mental health day hospital inpatient.
  • Smoker of at least 1 cigarette per day, electronic cigarette, or heated tobacco product daily for at least 1 month.
  • Individuals who accept to participate in the study and give informed consent.

排除标准

  • Cognitive impairment, dementia, or brain damage.
  • Medically unstable.
  • Explicitly demanding tobacco treatment.
  • Trying to quit smoking using another intervention.
  • Insufficient comprehension skills in Spanish or Catalan.

结局指标

主要结局

Tobacco use changes from baseline to post-intervention

时间窗: An average of 2 months

Number of cigarettes smoked in past 24 hours.

Motivation to quit smoking changes from baseline to post-intervention

时间窗: An average of 2 months

Individuals will be assessed with the Richmond test.

Cotinine levels in urine changes from baseline to post-intervention

时间窗: An average of 2 months

Urine cotinine levels

次要结局

  • Nicotine dependence changes from baseline to post-intervention(An average of 2 months)
  • Self-efficacy to quit smoking changes from baseline to post-intervention(An average of 2 months)
  • Depressive symptoms changes from baseline to post-intervention(An average of 2 months)
  • Smoking knowledge changes from baseline to post-intervention(An average of 2 months)
  • Trait and state anxiety changes from baseline to post-intervention(An average of 2 months)
  • Self-reported clinically relevant psychological symptoms changes from baseline to post-intervention(An average of 2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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