Interventional Study on Smoking Reduction in Psychiatry (TABAPSY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Addiction
• Intervention / Treatment: Other: TABAPSY; Other: Usual Care

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 12 months, in 22 participating sectors.

• Study Type: Interventional
• Enrollment (Estimated): 6500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Luc ROELANDT, MD; Phone Number: +33 3 20 43 71 00; Email: jean-luc.roelandt@ghtpsy-npdc.fr

Study Locations

• France
  • Armentières, France, 59280
    • Recruiting
    • Public mental health establishment of Lille Metropole (59G16-G17)
    • Contact: Nicolas LALAUX, MD; Phone Number: * +33 3 20 28 98 51; Email: nicolas.lalaux@ghtpsy-npdc.fr
    • Principal Investigator: Nicolas LALAUX, MD
  • Armentières, France, 59280
    • Recruiting
    • Public mental health establishment of Lille Metropole (59G21)
    • Contact: Deborah SEBBANE, MD; Phone Number: + 33 3 20 61 75 57; Email: deborah.sebbane@ghtpsy-npdc.fr
    • Principal Investigator: Deborah SEBBANE, MD
  • Bailleul, France, 59270
    • Recruiting
    • Flanders public mental health establishment (59G05/06)
    • Contact: Bernard LEFEBVRE, MD; Phone Number: +33 3 28 42 24 33; Email: BERNARD.LEFEBVRE@ghtpsy-npdc.fr
    • Principal Investigator: Judith COUTURIER, MD
  • Laxou, France, 54520
    • Recruiting
    • Psychotherapeutic center of Nancy (54G02-06)
    • Contact: François LARUELLE, MD; Phone Number: + 33 3 83 91 64 79; Email: Francois.LARUELLE@cpn-laxou.com
    • Principal Investigator: François LARUELLE, MD
  • Lille, France, 59000
    • Withdrawn
    • University Hospital Center of Lille (59G08)
  • Nanterre, France, 92014
    • Recruiting
    • Hospital Care Center of Nanterre (92G10)
    • Contact: Hocine BOUNAR, MD; Phone Number: +33 1 47 21 40 00; Email: hocine.bounar@ch-nanterre.fr
    • Principal Investigator: Hocine BOUNAR, MD
  • Paris, France, 75014
    • Recruiting
    • University Hospital Group Paris Neurosciences & Psychiatry (75G04)
    • Contact: Alberto VELASCO, MD; Phone Number: +33 1 45 65 77 75; Email: a.velasco@ghu-paris.fr
    • Principal Investigator: Alberto VELASCO, MD
  • Rouffach, France, 68250
    • Recruiting
    • Hospital Center of Rouffach (68G02/03)
    • Contact: Marius SAMOILA, MD; Phone Number: +33 3 89 78 70 12; Email: marius-bogdan.samoila@ch-rouffach.fr
    • Principal Investigator: Marius SAMOILA, MD
  • Rouffach, France, 68250
    • Recruiting
    • Hospital Center of Rouffach (68G08/09)
    • Contact: Mihaela TOMSA, MD; Phone Number: + 33 3 89 78 70 18; Email: mihaela-ioana.tomsa@ch-rouffach.fr
    • Principal Investigator: Mihaela TOMSA, MD
  • Rouffach, France, 68250
    • Recruiting
    • Hospital Center of Rouffach (Pôle LTD - 68G04/05)
    • Contact: Joël OBERLIN, MD; Phone Number: +33 3 89 78 74 22; Email: joel.oberlin@ch-rouffach.fr
    • Principal Investigator: Isabelle HASSLER, MD
  • Saint-Maurice, France, 94410
    • Recruiting
    • Hospitals of Paris Est Val de Marne (94G01)
    • Contact: Mazen HAMDANE, MD; Phone Number: +33 1 45 93 71 82; Email: Mazen.HAMDANE@ght94n.fr
    • Principal Investigator: Mazen HAMDANE, MD
  • Saint-Maurice, France, 94410
    • Recruiting
    • Hospitals of Paris Est Val de Marne (94G16)
    • Contact: Alain CANTERO, MD; Phone Number: +33 1 43 96 61 75; Email: Alain.CANTERO@ght94n.fr
    • Principal Investigator: Thomas DAVID, MD
  • Saint-Maurice, France, 94410
    • Recruiting
    • Hospitals of Paris Est Val de Marne (Paris 11)
    • Contact: Marie-Liesse DE LANVERSIN, MD; Phone Number: +33 1 43 96 65 86; Email: marieliesse.delanversin@ght94n.fr
    • Principal Investigator: Wayne GUILLAUME, MD
    • Principal Investigator: Edgar PLANCHENAULT, MD
  • Saint-Maurice, France, 94410
    • Recruiting
    • Hospitals of Paris Est Val de Marne (Paris 12)
    • Contact: Nicolas PASTOUR, MD; Phone Number: + 33 1 43 96 62 00; Email: nicolas.pastour@ght94n.fr
    • Principal Investigator: Gilles FOCK YEE, MD
    • Principal Investigator: Quentin PILETTE, MD
  • Saint-Maurice, France, 94410
    • Recruiting
    • Hospitals of Paris Est Val de Marne (Paris Centre)
    • Contact: Frédéric KHIDICHIAN, MD; Phone Number: +33 1 43 96 61 12; Email: Frederic.KHIDICHIAN@ght94n.fr
    • Principal Investigator: Frédéric KHIDICHIAN, MD
  • Saint-Venant, France, 62350
    • Recruiting
    • Public mental health establishment of Val de Lys Artois (62G09)
    • Contact: Dany WAMBERGUE, MD; Phone Number: +33 3 21 63 73 53; Email: dany.wambergue@ghtpsy-npdc.fr
    • Principal Investigator: Dany WAMBERGUE, MD
  • Saint-Venant, France, 62350
    • Recruiting
    • Public mental health establishment of Val de Lys Artois (62G12)
    • Contact: Dany WAMBERGUE, MD; Phone Number: +33 3 21 63 73 53; Email: dany.wambergue@ghtpsy-npdc.fr
    • Principal Investigator: Dany WAMBERGUE, MD
  • Saint-Venant, France, 62350
    • Recruiting
    • Public mental health establishment of Val de Lys Artois (Pôle du Ternois)
    • Contact: Aurélie GREBERT, MD; Phone Number: +33 3 21 41 36 88; Email: aurelie.grebert@ghtpsy-npdc.fr
    • Principal Investigator: Benoît BARATTO, MD
  • Étampes, France, 91150
    • Recruiting
    • Barthelemy Durand public health establishment (91G05)
    • Contact: Amina AMRANDI, MD; Phone Number: + 33 1 69 46 86 66; Email: amina.amrandi@eps-etampes.fr
    • Principal Investigator: Amina AMRANDI, MD
• Guadeloupe
  • Saint-Claude, Guadeloupe, 97122
    • Recruiting
    • Public mental health establishment of Guadeloupe (96G06)
    • Contact: Isabelle DELAROZIERE, MD; Phone Number: +590 5 90 41 48 68; Email: isabelle.delaroziere@epsm-guadeloupe.fr
    • Principal Investigator: Isabelle DELAROZIERE, MD
  • Saint-Claude, Guadeloupe, 97122
    • Recruiting
    • Public mental health establishment of Guadeloupe (96G01)
    • Contact: Daniel CAPERET, MD; Phone Number: +590 5 90 80 52 62; Email: Daniel.CAPERET@epsm-guadeloupe.fr
    • Principal Investigator: Magloire MPEMBI, MD
• Reunion
  • Saint-Paul, Reunion, 97460
    • Recruiting
    • Public mental health establishment of Reunion Island (Pôle Nord)
    • Contact: Nasima KARJANIA, MD; Phone Number: +262 2 62 74 01 40; Email: n.karjania@epsmr.org
    • Principal Investigator: Eugène BAJYANA SONGA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Sectors randomized to the intervention group will implement the 'Tabapsy' intervention.	Other: TABAPSY; 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
Other: Usual care; Sectors randomized to the control group will continue implementing their usual smoking cessation promotion.	Other: Usual Care; 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.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	3 and 6 months
Tobacco consumption	Number of cigarettes smoked per day	3 and 6 months
Nicotine dependence	Nicotine dependence will be measured by the 6-question Fagerström test.	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.	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.	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	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	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	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	3 and 6 months
Cost-effectiveness (short-term)	Incremental cost-effectiveness ratio in cost per additional weaning of at least 7 days.	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.	6 months
Budgetary impact (costs)	Direct costs will be calculated with and without the Tabapsy intervention to assess the budgetary impact of its generalization.	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.	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).	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.	3 and 6 months

Collaborators and Investigators

• Sponsor: GCS-CCOMS
• Collaborators: INSERM ECEVE 1123
• Investigators: Principal Investigator: Jean-Luc ROELANDT, MD, GCS-CCOMS & INSERM ECEVE 1123; Study Director: Karine CHEVREUL, MD and Pr of public health, Evaluation and research in health services and policies for vulnerable populations, French National Institute for Health and Medical Research (INSERM ECEVE 11 23)

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): November 14, 2026

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Psychiatry; Smoking reduction; People with mental disorders
• Additional Relevant MeSH Terms: Behavior; Smoking; Health Behavior; Smoking Reduction
• Other Study ID Numbers: 2024-A01474-43; A19017HS (Other Identifier: Institute for Public Health Research (IRESP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No