Ireland
--:--IST
Recruiting Not applicable

Interventional Study on Smoking Reduction in Psychiatry

NCT06926153 · tracked via the Priya Life Science France tracker
Sponsor
GCS-CCOMS
Phase
Not applicable
Started
2025-01-15
Last updated
2026-10-08

Condition(s) studied

Tobacco Addiction

Investigational drug(s) / intervention(s)

TABAPSYUsual Care

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

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.)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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.

Trial sites (22)

FacilityCityRegionStatus
Public mental health establishment of Lille Metropole (59G16-G17) Armentières France Completed
Public mental health establishment of Lille Metropole (59G21) Armentières France Completed
Flanders public mental health establishment (59G05/06) Bailleul France Completed
Barthelemy Durand public health establishment (91G05) Étampes France Recruiting
Psychotherapeutic center of Nancy (54G02-06) Laxou France Completed
University Hospital Center of Lille (59G08) Lille France Withdrawn
Hospital Care Center of Nanterre (92G10) Nanterre France Completed
University Hospital Group Paris Neurosciences & Psychiatry (75G04) Paris France Completed
Hospital Center of Rouffach (68G02/03) Rouffach France Completed
Hospital Center of Rouffach (68G08/09) Rouffach France Completed
Hospital Center of Rouffach (Pôle LTD - 68G04/05) Rouffach France Completed
Hospitals of Paris Est Val de Marne (94G01) Saint-Maurice France Completed
Hospitals of Paris Est Val de Marne (94G16) Saint-Maurice France Completed
Hospitals of Paris Est Val de Marne (Paris 11) Saint-Maurice France Completed
Hospitals of Paris Est Val de Marne (Paris 12) Saint-Maurice France Completed
Hospitals of Paris Est Val de Marne (Paris Centre) Saint-Maurice France Completed
Public mental health establishment of Val de Lys Artois (62G09) Saint-Venant France Completed
Public mental health establishment of Val de Lys Artois (62G12) Saint-Venant France Completed
Public mental health establishment of Val de Lys Artois (Pôle du Ternois) Saint-Venant France Completed
Public mental health establishment of Guadeloupe (96G01) Saint-Claude Guadeloupe Recruiting
Public mental health establishment of Guadeloupe (96G06) Saint-Claude Guadeloupe Recruiting
Public mental health establishment of Reunion Island (Pôle Nord) Saint-Paul Reunion Completed

More GCS-CCOMS trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06926153 on ClinicalTrials.gov ↗ ← All trials in France