Interventional Study on Smoking Reduction in Psychiatry

NCT06926153 | Recruiting

• 2 other identifiers: 2024-A01474-43A19017HS
• Study Type: interventional
• Target: 6,500
• Locations: 3 countries
• Sites: 22

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.

Conditions

Tobacco Addiction

Keywords

Smoking reduction; People with mental disorders; Psychiatry

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (17)

• Motivation to stop smoking

  3 and 6 months

• Voluntary quit attempts lasting at least 24 hours in the last 3 months

  3 and 6 months

• Voluntary quit attempts lasting at least 7 days in the last 3 months

  3 and 6 months

• Tobacco consumption

  3 and 6 months

• Nicotine dependence

  3 and 6 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Sectors randomized to the intervention group will implement the 'Tabapsy' intervention.

Other: TABAPSY

Usual care

OTHER

Sectors randomized to the control group will continue implementing their usual smoking cessation promotion.

Other: Usual Care

Interventions

TABAPSY OTHER

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

Intervention arm

Usual Care OTHER

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.)

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• GCS-CCOMS: lead
• INSERM ECEVE 1123: collaborator

Study Sites (22)

Public mental health establishment of Lille Metropole (59G16-G17)

Armentières, 59280, France

RECRUITING

Public mental health establishment of Lille Metropole (59G21)

Armentières, 59280, France

RECRUITING

Flanders public mental health establishment (59G05/06)

Bailleul, 59270, France

RECRUITING

Barthelemy Durand public health establishment (91G05)

Étampes, 91150, France

RECRUITING

Psychotherapeutic center of Nancy (54G02-06)

Laxou, 54520, France

RECRUITING

University Hospital Center of Lille (59G08)

Lille, 59000, France

WITHDRAWN

Hospital Care Center of Nanterre (92G10)

Nanterre, 92014, France

RECRUITING

University Hospital Group Paris Neurosciences & Psychiatry (75G04)

Paris, 75014, France

RECRUITING

Hospital Center of Rouffach (68G02/03)

Rouffach, 68250, France

RECRUITING

Hospital Center of Rouffach (68G08/09)

Rouffach, 68250, France

RECRUITING

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

Rouffach, 68250, France

RECRUITING

Hospitals of Paris Est Val de Marne (94G01)

Saint-Maurice, 94410, France

RECRUITING

Hospitals of Paris Est Val de Marne (94G16)

Saint-Maurice, 94410, France

RECRUITING

Hospitals of Paris Est Val de Marne (Paris 11)

Saint-Maurice, 94410, France

RECRUITING

Hospitals of Paris Est Val de Marne (Paris 12)

Saint-Maurice, 94410, France

RECRUITING

Hospitals of Paris Est Val de Marne (Paris Centre)

Saint-Maurice, 94410, France

RECRUITING

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

Saint-Venant, 62350, France

RECRUITING

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

Saint-Venant, 62350, France

RECRUITING

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

Saint-Venant, 62350, France

RECRUITING

Public mental health establishment of Guadeloupe (96G01)

Saint-Claude, 97122, Guadeloupe

RECRUITING

Public mental health establishment of Guadeloupe (96G06)

Saint-Claude, 97122, Guadeloupe

RECRUITING

Public mental health establishment of Reunion Island (Pôle Nord)

Saint-Paul, 97460, Reunion

RECRUITING

MeSH Terms

Conditions

Smoking Reduction

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Study Officials

• Jean-Luc ROELANDT, MD

  GCS-CCOMS & INSERM ECEVE 1123

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Jean-Luc ROELANDT, MD

CONTACT

+33 3 20 43 71 00; jean-luc.roelandt@ghtpsy-npdc.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: April 13, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): November 14, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (19); RE (1); GU (2)