An interventional study of TABAPSY and Usual Care in Tobacco Addiction, sponsored by GCS-CCOMS. Recruiting at 22 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by GCS-CCOMS · Not applicable, Interventional, and Prevention
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.
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:
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 12 months, in 22 participating sectors.
56 studies on the registry are indexed under Smoking Reduction; 13 are open to participants now.
This study's planned enrollment of 6,500 is above the median of 222 across 48 interventional studies indexed under Smoking Reduction.
Browse Smoking Reduction studies →GCS-CCOMS is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sectors randomized to the intervention group will implement the 'Tabapsy' intervention.
Other: TABAPSY
Sectors randomized to the control group will continue implementing their usual smoking cessation promotion.
Other: Usual Care
The Tabapsy intervention consists in a campaign to promote smoking cessation within the CMP, and an intervention to help people stop smoking which comprises of a) A general information meeting; b) An assessment workshop, to evaluate level of dependence using validated tests and establish a personalized cessation program based on the results obtained; c) 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; d) 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 relies on a facilitator specifically recruited to implement and run the intervention in the CMP. It is complemented by a website that will contain all the resources and information presented dur
Usual care corresponds to usual practices regarding smoking cessation activities in participating sectors. Those practices may vary (enquiring whether a patient is a smoker or not, offering smoking cessation if they are or only if the patient asks, etc.)
Short-term smoking cessation
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.
Time frame: 3 months
Motivation to stop smoking
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.
Time frame: 3 and 6 months
Voluntary quit attempts lasting at least 24 hours in the last 3 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
Time frame: 3 and 6 months
Voluntary quit attempts lasting at least 7 days in the last 3 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.
Time frame: 3 and 6 months
Tobacco consumption
Number of cigarettes smoked per day
Time frame: 3 and 6 months
Nicotine dependence
Nicotine dependence will be measured by the 6-question Fagerström test.
Time frame: 3 and 6 months
Short-term smoking cessation
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.
Time frame: 6 months
Medium-term smoking cessation
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.
Time frame: At 3 and 6 months
Use of smoking cessation aids
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
Time frame: 3 and 6 months
Level of mental well-being
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
Time frame: 3 and 6 months
Level of physical well-being
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
Time frame: 3 and 6 months
Knowledge and representations surrounding tobacco use
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
Time frame: 3 and 6 months
Cost-effectiveness (short-term)
Incremental cost-effectiveness ratio in cost per additional weaning of at least 7 days.
Time frame: A 6 months
Cost-effectiveness (long-term)
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.
Time frame: 6 months
Budgetary impact (costs)
Direct costs will be calculated with and without the Tabapsy intervention to assess the budgetary impact of its generalization.
Time frame: 5 years after hypothetical generalization
Budgetary impact (health benefits)
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.
Time frame: 5 years after hypothetical generalization
Implementation
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).
Time frame: 6 months
Satisfaction level
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.
Time frame: 3 and 6 months
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2025 to primary completion in Jul 2026, 18 months.
Of 24 interventional studies with no phase under Smoking Reduction, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 44. This study's 18 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GCS-CCOMS