AzTrials
AzTrials

Tobacco AddictionTABAPSYNCT06926153

Interventional Study on Smoking Reduction in Psychiatry

A study testing TABAPSY in people with Tobacco Addiction, run by GCS-CCOMS at 22 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tobacco Addiction
What is being tested?
TABAPSY
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,500 participants
Where
22 sitesin 3 countries
Study dates
15 Jan 2025to 14 Nov 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

22 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

22 sites in 3 countries

France19 sites, 1 recruiting
  • Public mental health establishment of Lille Metropole (59G16-G17)

    Armentières, 59280

    Completed
  • Public mental health establishment of Lille Metropole (59G21)

    Armentières, 59280

    Completed
  • Flanders public mental health establishment (59G05/06)

    Bailleul, 59270

    Completed
  • Barthelemy Durand public health establishment (91G05)

    Étampes, 91150

    Amina AMRANDI, MD, + 33 1 69 46 86 66, amina.amrandi@eps-etampes.fr

    Amina AMRANDI, MD

    Recruiting
  • Psychotherapeutic center of Nancy (54G02-06)

    Laxou, 54520

    Completed
  • University Hospital Center of Lille (59G08)

    Lille, 59000

    Withdrawn
  • Hospital Care Center of Nanterre (92G10)

    Nanterre, 92014

    Completed
  • University Hospital Group Paris Neurosciences & Psychiatry (75G04)

    Paris, 75014

    Completed
  • Hospital Center of Rouffach (68G02/03)

    Rouffach, 68250

    Completed
  • Hospital Center of Rouffach (68G08/09)

    Rouffach, 68250

    Completed
  • Hospital Center of Rouffach (Pôle LTD - 68G04/05)

    Rouffach, 68250

    Completed
  • Hospitals of Paris Est Val de Marne (94G01)

    Saint-Maurice, 94410

    Completed
  • Hospitals of Paris Est Val de Marne (94G16)

    Saint-Maurice, 94410

    Completed
  • Hospitals of Paris Est Val de Marne (Paris 11)

    Saint-Maurice, 94410

    Completed
  • Hospitals of Paris Est Val de Marne (Paris 12)

    Saint-Maurice, 94410

    Completed
  • Hospitals of Paris Est Val de Marne (Paris Centre)

    Saint-Maurice, 94410

    Completed
  • Public mental health establishment of Val de Lys Artois (62G09)

    Saint-Venant, 62350

    Completed
  • Public mental health establishment of Val de Lys Artois (62G12)

    Saint-Venant, 62350

    Completed
  • Public mental health establishment of Val de Lys Artois (Pôle du Ternois)

    Saint-Venant, 62350

    Completed

Other trials in France

Guadeloupe2 sites, 2 recruiting
  • Public mental health establishment of Guadeloupe (96G01)

    Saint-Claude, 97122

    Daniel CAPERET, MD, +590 5 90 80 52 62, Daniel.CAPERET@epsm-guadeloupe.fr

    Magloire MPEMBI, MD

    Recruiting
  • Public mental health establishment of Guadeloupe (96G06)

    Saint-Claude, 97122

    Isabelle DELAROZIERE, MD, +590 5 90 41 48 68, isabelle.delaroziere@epsm-guadeloupe.fr

    Isabelle DELAROZIERE, MD

    Recruiting

Other trials in Guadeloupe

Reunion1 site
  • Public mental health establishment of Reunion Island (Pôle Nord)

    Saint-Paul, 97460

    Completed

Other trials in Reunion

About this study

Official title: 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.

Read the 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.

Being tested
TABAPSY, Usual Care
Keywords
Smoking reduction, People with mental disorders, Psychiatry
Medical subject headings
Smoking Reduction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TABAPSYOther

    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 CareOther

    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.)

Study groups in NCT06926153
Study groupRoleWhat they receive
Intervention armExperimentalSectors randomized to the intervention group will implement the 'Tabapsy' intervention.
Receives: Other: TABAPSY
Usual careOtherSectors randomized to the control group will continue implementing their usual smoking cessation promotion.
Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

Secondary outcomes (17)
  1. 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.

    Measured: 3 and 6 months

  2. 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

    Measured: 3 and 6 months

  3. 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.

    Measured: 3 and 6 months

  4. Tobacco consumption

    Number of cigarettes smoked per day

    Measured: 3 and 6 months

  5. Nicotine dependence

    Nicotine dependence will be measured by the 6-question Fagerström test.

    Measured: 3 and 6 months

  6. 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.

    Measured: 6 months

  7. 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.

    Measured: At 3 and 6 months

  8. 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

    Measured: 3 and 6 months

  9. 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

    Measured: 3 and 6 months

  10. 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

    Measured: 3 and 6 months

  11. 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

    Measured: 3 and 6 months

  12. Cost-effectiveness (short-term)

    Incremental cost-effectiveness ratio in cost per additional weaning of at least 7 days.

    Measured: A 6 months

  13. 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.

    Measured: 6 months

  14. Budgetary impact (costs)

    Direct costs will be calculated with and without the Tabapsy intervention to assess the budgetary impact of its generalization.

    Measured: 5 years after hypothetical generalization

  15. 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.

    Measured: 5 years after hypothetical generalization

  16. 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).

    Measured: 6 months

  17. 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.

    Measured: 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study start15 Jan 2025
  3. Primary completion15 Jul 2026
  4. Study completion14 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06926153
Sponsor's protocol ID
2024-A01474-43
Other IDs
A19017HS
Acronym
TABAPSY
Status last verified
Oct 2026
First submitted
18 Feb 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in