Clinical trial NCT06926153: Interventional Study on Smoking Reduction in Psychiatry
Official title: Evaluation of an Intervention to Reduce Smoking Among Mental Health Users Treated in Ambulatory Psychiatry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Addiction
Keywords: Smoking reduction
People with mental disorders
Psychiatry
Lead sponsor: GCS-CCOMS
Sponsor class: OTHER
Collaborators: name: INSERM ECEVE 1123
First posted: 2025-04-13
Enrollment: 6500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

The primary objective of the study is to evaluate the effectiveness of the "Tabapsy" intervention on short-term smoking cessation (cessation for at least 7 days) at 3 months among regular smokers followed by adult psychiatric CMPs. Secondary objectives include assessing its cost-effectiveness and implementation.

A cluster-randomized controlled trial will be carried out to evaluate the intervention. The cluster is the "psychiatric sector", i.e., the public care entity responsible for organizing the mental health care of a population within a pre-specified geographical area (including hospital and ambulatory care) in France. A psychiatric sector may include one or multiple CMPs depending on the size of the population it serves. Psychiatric sectors will be randomized into one of two groups (intervention or usual practice).

It will be supplemented by a qualitative study to study the implementation of the intervention.

All regular smokers (at least one cigarette a day) who agree to participate will be asked to complete questionnaires on a WebApp at inclusion, and again at 3 and 6 months. Additional questionnaires will be available in the intervention group. Questions will focus on user characteristics, tobacco consumption, level of nicotine dependence, motivation to quit, use of cessation aids, level of mental and physical well-being, smoking-related knowledge and representations, and in the intervention group, participation in the intervention and satisfaction.

6,250 participants will be included over 6 months, in 22 participating sectors.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Short-term smoking cessation
timeFrame: 3 months
Secondary outcomes:
measure: Motivation to stop smoking
timeFrame: 3 and 6 months
measure: Voluntary quit attempts lasting at least 24 hours in the last 3 months
timeFrame: 3 and 6 months
measure: Voluntary quit attempts lasting at least 7 days in the last 3 months
timeFrame: 3 and 6 months
measure: Tobacco consumption
timeFrame: 3 and 6 months
measure: Nicotine dependence
timeFrame: 3 and 6 months
measure: Short-term smoking cessation
timeFrame: 6 months
measure: Medium-term smoking cessation
timeFrame: At 3 and 6 months
measure: Use of smoking cessation aids
timeFrame: 3 and 6 months
measure: Level of mental well-being
timeFrame: 3 and 6 months
measure: Level of physical well-being
timeFrame: 3 and 6 months
measure: Knowledge and representations surrounding tobacco use
timeFrame: 3 and 6 months
measure: Cost-effectiveness (short-term)
timeFrame: A 6 months
measure: Cost-effectiveness (long-term)
timeFrame: 6 months
measure: Budgetary impact (costs)
timeFrame: 5 years after hypothetical generalization
measure: Budgetary impact (health benefits)
timeFrame: 5 years after hypothetical generalization
measure: Implementation
timeFrame: 6 months
measure: Satisfaction level
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Armentières
country: France
facility: Public mental health establishment of Lille Metropole (59G16-G17)
city: Armentières
country: France
facility: Public mental health establishment of Lille Metropole (59G21)
city: Bailleul
country: France
facility: Flanders public mental health establishment (59G05/06)
city: Etampes
country: France
facility: Barthelemy Durand public health establishment (91G05)
city: Laxou
country: France
facility: Psychotherapeutic center of Nancy (54G02-06)
city: Lille
country: France
facility: University Hospital Center of Lille (59G08)
city: Nanterre
country: France
facility: Hospital Care Center of Nanterre (92G10)
city: Paris
country: France
facility: University Hospital Group Paris Neurosciences & Psychiatry (75G04)
city: Rouffach
country: France
facility: Hospital Center of Rouffach (68G02/03)
city: Rouffach
country: France
facility: Hospital Center of Rouffach (68G08/09)
city: Rouffach
country: France
facility: Hospital Center of Rouffach (Pôle LTD - 68G04/05)
city: Saint-Maurice
country: France
facility: Hospitals of Paris Est Val de Marne (94G01)
city: Saint-Maurice
country: France
facility: Hospitals of Paris Est Val de Marne (94G16)
city: Saint-Maurice
country: France
facility: Hospitals of Paris Est Val de Marne (Paris 11)
city: Saint-Maurice
country: France
facility: Hospitals of Paris Est Val de Marne (Paris 12)
city: Saint-Maurice
country: France
facility: Hospitals of Paris Est Val de Marne (Paris Centre)
city: Saint-Venant
country: France
facility: Public mental health establishment of Val de Lys Artois (62G09)
city: Saint-Venant
country: France
facility: Public mental health establishment of Val de Lys Artois (62G12)
city: Saint-Venant
country: France
facility: Public mental health establishment of Val de Lys Artois (Pôle du Ternois)
city: Saint-Claude
country: Guadeloupe
facility: Public mental health establishment of Guadeloupe (96G01)
city: Saint-Claude
country: Guadeloupe
facility: Public mental health establishment of Guadeloupe (96G06)
city: Saint-Paul
country: Réunion
facility: Public mental health establishment of Reunion Island (Pôle Nord)
Study officials:
affiliation: GCS-CCOMS & INSERM ECEVE 1123
name: Jean-Luc ROELANDT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Evaluation and research in health services and policies for vulnerable populations, French National Institute for Health and Medical Research (INSERM ECEVE 11 23)
name: Karine CHEVREUL, MD and Pr of public health
role: STUDY_DIRECTOR
References: