Interventional Study on Smoking Reduction in Psychiatry
ConditionTobacco Addiction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS-CCOMS
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Users under guardianship or legal protection,
Psychological state incompatible with completing the questionnaire,
Persons with no command or understanding of the French language
Trial design
Design model
Parallel
Treatments tested in this trial
TABAPSY
Other interventionThe 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
Other interventionUsual 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.)
Treatment groups
6,500 Participants
are divided into 2 treatment groupsGroup A: Intervention armExperimental treatment 1 intervention
Group B: Usual careOther 1 intervention
Trial outcomes
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.
Time frame
3 monthsSecondary outcomes
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.
Time frame
3 and 6 months2
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 months3
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 months4
Tobacco consumption
Number of cigarettes smoked per day
Time frame
3 and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
GCS-CCOMS
Lead sponsor
INSERM ECEVE 1123
Collaborator
Source ClinicalTrials.gov