Interventional Study on Smoking Reduction in Psychiatry

Not Applicable

Recruiting

• Conditions: Tobacco Addiction

• Registration Number: NCT06926153
• Lead Sponsor: GCS-CCOMS

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.

Study Timeline

• Study Start: 2025-01-15
• Study First Submitted: 2025-02-18
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-07
• Study First Posted: 2025-04-13
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-01-14
• Study Completion: 2026-07-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Short-term smoking cessation	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.

Secondary Outcome Measures

Name	Time	Method
Short-term smoking cessation	6 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.
Medium-term smoking cessation	At 3 and 6 months	Medium-term smoking cessation corresponds to a smoking cessation of at least 30 days, assessed among regular smoker (at least one cigarette a day) included in the study.
Level of mental well-being	3 and 6 months	Level of mental well-being assessed with a visual analog scale ranging from 1 to 10, 10 representing the highest level of mental well-being
Level of physical well-being	3 and 6 months	Level of physical well-being assessed with a visual analog scale ranging from 1 to 10, 10 representing the highest level of physical well-being
Motivation to stop smoking	3 and 6 months	The motivation to stop smoking will be assessed using the Q-Mat ("Questionnaire de motivation à l'arrêt du tabac") scale. The computed score ranges from 0 to 20, 20 representing the highest motivation.
Voluntary quit attempts lasting at least 24 hours in the last 3 months	3 and 6 months	Number of voluntary quit attempts assessed both as percentage of users reporting at least one quit attempt and mean number of quit attempts per use
Voluntary quit attempts lasting at least 7 days in the last 3 months	3 and 6 months	Number of voluntary quit attempts assessed both as percentage of users reporting at least one quit attempt and mean number of quit attempts per user.
Tobacco consumption	3 and 6 months	Number of cigarettes smoked per day
Nicotine dependence	3 and 6 months	Nicotine dependence will be measured by the 6-question Fagerström test.
Use of smoking cessation aids	3 and 6 months	Number of participants using smoking cessation aids (nicotine replacement therapy and other smoking cessation medications (varenicline or bupropion), electronic cigarettes, and health professionals, assessed together and separately
Knowledge and representations surrounding tobacco use	3 and 6 months	Knowledge and representations surrounding tobacco use will be assessed using a dedicated questionnaire addressed to all the included population as well as to patients who participated to a given workshop
Cost-effectiveness (short-term)	A 6 months	Incremental cost-effectiveness ratio in cost per additional weaning of at least 7 days.
Cost-effectiveness (long-term)	6 months	Incremental cost-effectiveness ratio in cost per life-year gained over the entire life of users, using extrapolated data and economic modeling (Markov model) to assess lifetime costs and effectiveness 'till all patients in the model are deceased.
Budgetary impact (costs)	5 years after hypothetical generalization	Direct costs will be calculated with and without the Tabapsy intervention to assess the budgetary impact of its generalization.
Budgetary impact (health benefits)	5 years after hypothetical generalization	The number of users who have stopped smoking for at least 7 days will be calculated with and without the Tabapsy intervention to assess the health gains associated with its generalization.
Implementation	6 months	The implementation of the intervention and its components will be assessed using qualitative methods through semi-structured interviews conducted with 25 mental health users et 25 mental health professionnals of the intervention group).
Satisfaction level	3 and 6 months	Users who participated in one of the components of the intervention will be asked to rate their satisfaction using a visual analog scale ranging from 0 to 10, with 10 corresponding to the highest satisfaction.

Trial Locations

Locations (22)

Public mental health establishment of Lille Metropole (59G16-G17); 🇫🇷 Armentières, France

Public mental health establishment of Lille Metropole (59G21); 🇫🇷 Armentières, France

Flanders public mental health establishment (59G05/06); 🇫🇷 Bailleul, France

Barthelemy Durand public health establishment (91G05); 🇫🇷 Etampes, France

Psychotherapeutic center of Nancy (54G02-06); 🇫🇷 Laxou, France

University Hospital Center of Lille (59G08); 🇫🇷 Lille, France

Hospital Care Center of Nanterre (92G10); 🇫🇷 Nanterre, France

University Hospital Group Paris Neurosciences & Psychiatry (75G04); 🇫🇷 Paris, France

Hospital Center of Rouffach (68G02/03); 🇫🇷 Rouffach, France

Hospital Center of Rouffach (68G08/09); 🇫🇷 Rouffach, France

Hospital Center of Rouffach (Pôle LTD - 68G04/05); 🇫🇷 Rouffach, France

Hospitals of Paris Est Val de Marne (94G01); 🇫🇷 Saint-Maurice, France

Hospitals of Paris Est Val de Marne (94G16); 🇫🇷 Saint-Maurice, France

Hospitals of Paris Est Val de Marne (Paris 11); 🇫🇷 Saint-Maurice, France

Hospitals of Paris Est Val de Marne (Paris 12); 🇫🇷 Saint-Maurice, France

Hospitals of Paris Est Val de Marne (Paris Centre); 🇫🇷 Saint-Maurice, France

Public mental health establishment of Val de Lys Artois (62G09); 🇫🇷 Saint-Venant, France

Public mental health establishment of Val de Lys Artois (62G12); 🇫🇷 Saint-Venant, France

Public mental health establishment of Val de Lys Artois (Pôle du Ternois); 🇫🇷 Saint-Venant, France

Public mental health establishment of Guadeloupe (96G01); 🇬🇵 Saint-Claude, Guadeloupe

Public mental health establishment of Guadeloupe (96G06); 🇬🇵 Saint-Claude, Guadeloupe

Public mental health establishment of Reunion Island (Pôle Nord); 🇷🇪 Saint-Paul, Réunion