跳至主要内容
临床试验/NCT06926153
NCT06926153招募中不适用

Evaluation of an Intervention to Reduce Smoking Among Mental Health Users Treated in Ambulatory Psychiatry

GCS-CCOMS22 个研究点 分布在 3 个国家目标入组 6,500 人开始时间: 2025年1月15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
发起方
入组人数
6,500
试验地点
22
主要终点
Short-term smoking cessation

研究概览

简要总结

The smoking rate among people with mental disorders is higher than in the general population. Greater exposure to the harmful effects of tobacco partly explains the major inequality in life expectancy observed among people with mental disorders who, depending on the disorder and the study, live 10 to 25 years less than the general population, a gap mainly due to the occurrence of cardiovascular and respiratory pathologies, notably bronchial cancers. However, tobacco reduction actions specifically targeting these people remain insufficiently developed, particularly in psychiatry where this addiction is often banalized and its treatment neglected.

The objective of this study is to evaluate an intervention ('Tabapsy') co-constructed with mental health services users, mental health professionals, and general practitioners and targeting adult patients followed in ambulatory psychiatry. The main objective is to evaluate the effectiveness of the intervention on short-term smoking cessation (cessation for at least 7 days) among regular smokers at 3 months. Secondary objectives include evaluation of its cost-effectiveness and implementation. To this end, a national cluster-randomized controlled study will be carried out, supplemented by qualitative interviews to study the implementation of the intervention.

详细描述

The smoking rate among people with mental disorders is higher than in the general population. Greater exposure to the harmful effects of tobacco partly explains the major inequality in life expectancy observed among people with mental disorders who, depending on the disorder and the study, live 10 to 20 years less than the general population, a gap mainly due to the occurrence of cardiovascular and respiratory pathologies, notably bronchial cancers.

While studies found that people under psychiatric care are as motivated as others to stop smoking, the literature also shows that psychiatric care systems tolerate, underestimate and even encourage smoking among users, despite the fact that psychiatric care, whether at hospital or in an ambulatory setting, is conducive to changes in smoking behaviour and to the implementation of a smoking cessation approach, notably because of anti-smoking regulations in hospitals. In addition, withdrawal symptoms is stronger in this population and smoking cessation would therefore need to be adapted.

Against this backdrop, a smoking cessation intervention ('Tabapsy') was co-constructed with the various stakeholders (users with mental disorders, mental health professionals and general practitioners). Its aim is to encourage and support smoking cessation among people with mental disorders followed in ambulatory psychiatry by medical psychological centers (CMP). It consists of two parts: a campaign to promote smoking cessation within the CMP, and the setting up of an intervention to help people stop smoking. The latter comprises of:

  1. A general information meeting, to encourage motivation to start smoking cessation;
  2. An assessment workshop, to evaluate level of dependence using validated tests and establish a personalized cessation program based on the results obtained;
  3. Five thematic workshops to support cessation, covering 1/ nicotine replacement treatments, electronic cigarettes and other drug treatments available for smoking cessation, 2/ emotional management, 3/ weight gain, 4/ physical activities, and 5/ manual occupations;
  4. Peer support groups, based on the sharing of experiences, to encourage mutual aid and solidarity between people with mental disorders who are trying to quit smoking.

The intervention also relies on a facilitator specifically recruited to set up the intervention and run the various workshops in the CMP. It is complemented by a website that will contain all the resources and information presented during the meetings/workshops.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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
否

入选标准

  • •Regular smokers (at least one cigarette per day)
  • •Followed in psychiatric ambulatory care at one of the participating sectors' CMPs
  • •Adults (18 years or older)
  • •Covered by the statuary health insurance
  • •Who gave their informed consent to participate to the study

排除标准

  • •Users under guardianship or legal protection,
  • •Psychological state incompatible with completing the questionnaire,
  • •Persons with no command or understanding of the French language

研究组 & 干预措施

Intervention arm

Experimental

Sectors randomized to the intervention group will implement the 'Tabapsy' intervention.

干预措施: TABAPSY (Other)

Usual care

Other

Sectors randomized to the control group will continue implementing their usual smoking cessation promotion.

干预措施: Usual Care (Other)

结局指标

主要结局

Short-term smoking cessation

时间窗: 3 months

Short-term smoking cessation corresponds to a smoking cessation of at least 7 days, assessed among regular smoker (at least one cigarette a day) included in the study.

次要结局

  • Short-term smoking cessation(6 months)
  • Medium-term smoking cessation(At 3 and 6 months)
  • Level of mental well-being(3 and 6 months)
  • Level of physical well-being(3 and 6 months)
  • Motivation to stop smoking(3 and 6 months)
  • Voluntary quit attempts lasting at least 24 hours in the last 3 months(3 and 6 months)
  • Voluntary quit attempts lasting at least 7 days in the last 3 months(3 and 6 months)
  • Tobacco consumption(3 and 6 months)
  • Nicotine dependence(3 and 6 months)
  • Use of smoking cessation aids(3 and 6 months)
  • Knowledge and representations surrounding tobacco use(3 and 6 months)
  • Cost-effectiveness (short-term)(A 6 months)
  • Cost-effectiveness (long-term)(6 months)
  • Budgetary impact (costs)(5 years after hypothetical generalization)
  • Budgetary impact (health benefits)(5 years after hypothetical generalization)
  • Implementation(6 months)
  • Satisfaction level(3 and 6 months)

研究者

发起方
GCS-CCOMS
申办方类型
Other
责任方
Sponsor

研究点 (22)

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