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Smoking CessationPSYTaBNCT06988644

Impact of a Counseling Consultation in the Workplace for Smoker Health Professionals

A study testing exhaled carbon monoxyde measurement in people with Smoking Cessation, run by Groupe Hospitalier Mutualiste de Grenoble at 1 site in France.

Recruiting

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

Sites and contacts
Official record
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Trial summary

Smoking is still a major cause of premature death in France (75,000 deaths a year). Health professionals also seem to be affected by smoking, but few studies have been carried out on this population of smokers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking Cessation
What is being tested?
exhaled carbon monoxyde measurement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
11 Nov 2024to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Age ≥ 18 years
  • Health professional
  • Daily smoker of at least 1 cigarette or joint per day and every day
  • Willingness to quit smoking
  • Patient physically able and willing to undertake a carbon monoxyde measurement
  • Patient affiliated to a social security scheme or beneficiary of such a scheme
  • Signature of informed consent

Who cannot join

  • Smoking via vaporizer exclusively
  • Occasional (i.e. not daily) smoker or exhaled carbon monoxyde at inclusion < 9 ppm
  • Resignation, transfer or end of employment contract during the study period (1 year)
  • Unable to undergo study follow-up for geographical, social or psychological reasons
  • Persons under legal protection or unable to express their consent.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Estelle Cotte-Raffour, Nursery contact

0033 476708995

estelle.cotte-raffour@avec.fr

Laurence Fabaron, Nursery contact

0033 4 76 56 48 37

lfabaron@ch-alpes-isere.fr

France1 site, 1 recruiting
  • Groupe Hospitalier Mutualiste Grenoble

    Grenoble, isere, 38000

    Adrien Monard, ARC, 0033 4 76 70 70 22, adrien.monard@avec.fr

    Corinne Camarada, ARC, 0033 476708995, corinne.camarada@avec.fr

    Recruiting

Other trials in France

About this study

Official title: Prospective Study Aimed at Evaluating the Effect of a Counseling Consultation in the Workplace for Smoker Employees in a Mental Health Establishment

Smoking is still a major cause of premature death in France (75,000 deaths a year). Health professionals also seem to be affected by smoking, but few studies have been carried out on this population of smokers. While having a job can be protective, certain working conditions are at risk: night shifts, stress, physical strain, burnout... In 2010, 23% of nurses and 40% of nursing auxiliaries were smokers. More recently, a study of 10,000 health professionals in a French health establishment in 2022 revealed a rate of 32% among nursing auxiliaries.

Data on smoking among health professionals is still scarce. Yet they seem essential, given that smoking among healthcare professionals seems to be an obstacle to dealing with patients' consumption and contributes to the erroneous representations that persist in psychiatry more than elsewhere, such as: "smoking with a patient makes an alliance with them", "smoking is a way of reducing psychological tension", "patients have other problems to deal with", "it won't work because they've been smoking for years". Smoking in mental health facilities is high among both patients and professionals.

Read more

Investigators now know that smoking has an impact on mood disorders and sleep. It aggravates all somatic and psychological pathologies and predisposes people to more diabetes, chronic bronchitis, cardiovascular disease, cancer, etc. It also interacts with many drugs.

Smoking screening and cessation assistance have become an indicator of quality somatic care in mental health institutions.

Investigators hypothesise that a consultation in the workplace can help employees to change their smoking habits.

The aims of this study are to assess the effect of a workplace smoking clinic on smokers employed in a mental health institution, and to describe their smoking habits and profiles according to occupational category, with a view to implementing appropriate preventive and treatment measures.

Read the detailed description

Smoking is still a major cause of premature death in France (75,000 deaths a year). Healthcare professionals also seem to be affected by smoking, and few studies have been carried out on this population of smokers.

In 2010, 23% of nurses and 40% of nursing auxiliaries in France said they smoked every day. In a more recent study on parisian hospitals, the prevalence of daily smoking was observed among 26.8% of nurse auxiliaries, 26.3% of nurses, 16.7% of physiotherapists, 27.6% of health managers and 27% of doctors. Among the 3,659 respondents to a study at the Hospices Civils de Lyon, the smoking rate among paramedics (nurses, nursing auxiliaries, and health managers) was 25.6%. Among doctors, pharmacists and dentists, the proportion of smokers is 17.3%, while it reaches 46% among technical and logistics staff. The same survey also showed that paramedical students are three times more likely to be smokers than medical students, and that night staff are 1.5 times more likely to be smokers, given the same age.

In mental health establishments, smoking is prevalent among both patients and healthcare professionals. Investigators now know that smoking affects mood and sleep. It aggravates all pathologies (somatic and psychological) and predisposes people to more diabetes, chronic bronchitis, cardiovascular disease, cancer, etc. It interacts with many psychotropic and analgesic drugs. Smoking screening and cessation assistance have become a quality of care indicator in mental health institutions.

Investigators hypothesise that easier access to smoking cessation consultations in the workplace will improve uptake of this support and encourage smoker carers to change their smoking habits, and that experimenting with this support will increase smoker carers' confidence in their ability to manage their patients' smoking.

The issue of smoking in patients with psychiatric comorbidity is a major one. Smoking significantly reduces their life expectancy: an average of 25 years less, compared with 10 years for smokers without mental disorders. Cardiovascular disease and cancer are the leading causes of premature death. Smoking also affects their quality of life by increasing their metabolic risk (diabetes), reducing their respiratory capacity (chronic obstructive bronchitis) and increasing their risk of chronic disabling pain (arteritis of the lower limbs). Healthcare professionals are expected to play an active role in the fight against smoking and to act as role models for those receiving care, promoting appropriate lifestyles to maintain good health.

Smoking by health professionals does not appear to be more prevalent at the Centre Hospitalier Alpes-Isère than in the general population: 25.9% compared with 25.5%, but this is still significant and probably contributes to the erroneous representations of smoking in psychiatry.

Today, the recommendations of the Haute Autorité de Santé specify that psychological support and assistance are the basis of treatment. Nicotine substitutes supplement this support if the smoker shows signs of nicotine dependence. For smoker health professionals, the offer of smoking counselling in the workplace is likely to encourage them to use these aids and to succeed.

In previous studies, investigators found cessation rates at 12 months of 33% in an intensive intervention group (NST, intensive advice and outpatient telephone follow-up) compared with 20% in a control group (minimal advice) (RR = 1.7; 95% CI: 1.1 to 2.7).

In a study of hospital smoking clinics, 29.5% of patients (schizophrenic patients were excluded) maintained cessation at 1 year: female gender and prematurely interrupted follow-up were significantly associated with the risk of relapse at 1 year.

With regard to smoker healthcare professionals, a meta-analysis published in 2020 of ten studies (6 cohort studies and 4 clinical trials) measured a one-year cessation rate of 21% following the application of pharmacological or behavioural interventions. Hajek et al. showed in a randomised trial that the vaporiser could double the success rate at 1 year compared with treatment with nicotine replacement therapy alone, if accompanied by behavioural support.

Invesigators therefore believe it is possible to achieve a one-year cessation rate of 30% with workplace consultations combining support, nicotine replacement therapy and/or a vapour device where appropriate.

Doctors' smoking status and attitudes towards smoking are known to influence their enthusiasm for advising their patients against smoking.

As the Nagahapitye et al. study made clear: 'It is reasonable to assume that a healthcare professional who is not a smoker or is a former smoker will be more committed and more convincing in spreading messages about smoking and cessation. Health professionals smoking habits are therefore an important factor in the prevention of tobacco-related diseases.

The hypotheses of PSYTaB are :

  • To improve cessation and reduction rates among smokers working in mental health,
  • To improve the management of their patients' smoking and representations of smoking.

This study may also highlight benefits for the healthcare establishment and society, notably in terms of reduction in sick leave rates.

This study involves no risk for the subject.

Being tested
exhaled carbon monoxyde measurement
Keywords
Smoking Cessation, Smoking consultation, carbon monoxyde measurement
Medical subject headings
Smoking Cessation

What participants receive

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

  • exhaled carbon monoxyde measurementDiagnostic test

    At the initial tobacco consultation: measurement of exhaled carbon monoxyde. At the tobaccology consultation at 12 months, measurement of the cessation rate: no tobacco smoked in the last 7 days (self-reported), confirmed by a measurement of exhaled carbon monoxyde < 9 ppm.

Study groups in NCT06988644
Study groupRoleWhat they receive
consultation tabaccoExperimentalAt the first T0 consultation, the tobacco nurse : * Carries out a monoxyde carbon measurement, In order to assess the patient's smoking profile and find out their degree of nicotine dependency, what might be holding them back from quitting, what might be motivating them, their psychological state, their fears and their medical history. * Define a programme for smoking cessation : the planned date for cessation, the treatment chosen, any additional specific therapy or consultations, and the date of the next appointments. During the 6-month follow-up sessions, the nurse assesses the patient's mood and anxiety, with a view to adapting the treatment if necessary. At the final consultation at T12 months, the nurse assesses the patient's withdrawal and the effect of the follow-up tobacco consultations.
Receives: Diagnostic Test: exhaled carbon monoxyde measurement

What is being measured

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

  1. Evalue the effectiveness of a counseling consultation in the workplace among smoker health professionals.

    Cessation rate at 12 months: At the 12-month visit, no smoking in the last 7 days (self-reported) confirmed by a measurement of exhaled carbon monoxyde < 9 ppm.

    Measured: At 12 month

Secondary outcomes (11)
  1. Prevalence of anxiety and depressive disorders

    Mean Hospital Anxiety and Depression Scale scores To screen for anxiety and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D) Total Score [0;21]

    • 7 or less: no symptoms
    • 8 to 10: doubtful symptomatology
    • 11 or more: definite symptomatology

    Measured: at inclusion

  2. Prevalence of chronic pain

    Pain numerical scale > 3/10 for 3 months or more

    Measured: at inclusion

  3. Prevalence of chronic fatigue

    Pichot scale, cut-off = 22

    Measured: at inclusion

  4. Effectiveness of counseling consultation on anxiety and depressive disorders

    Mean Hospital Anxiety and Depression Scale scores To screen for anxiety and depressive symptoms, the following interpretation can be proposed for each of the scores (A and D), Total score [0;21]

    • 7 or less: no symptoms
    • 8 to 10: doubtful symptomatology
    • 11 or more: definite symptomatology

    Measured: at inclusion, 6 months and 12 months

  5. Effectiveness of counseling consultation on pain

    Mean Pain Numerical Scale in the last 24 hours. Numerical scale from 0 to 10. Note 0 corresponds to "no pain". Note 10 corresponds to "maximum imaginable pain".

    Measured: at inclusion, 6 months and 12 months

  6. Effectiveness of counseling consultation on chronic fatigue

    Pichot scale score Total Score [0; 32] A total > 22 indicates excessive fatigue

    Measured: at inclusion, 6 months and 12 months

  7. Effectiveness of counseling consultation on the sense of personal efficacy with consumption and management of patients' smoking habits

    Numerical scale from 0 to 10 (0 means 'I'm absolutely sure I won't make it' and 10 means 'I'm absolutely sure I'll make it')

    Measured: at inclusion , 12 months.

  8. Effectiveness of counseling consultation on use of ancillary products

    Rate of subjects using ancillary products and search for other uses and intentions (cessation or reduction)

    Measured: at inclusion, 12 months

  9. Medico-economic impact of counseling consultation

    Number of sick leave days

    Measured: between inclusion and 12-month follow-up

  10. Prevalence of burnouts

    Maslach scale score

    The questionnaire thus yields 3 scores:

    • Professional Exhaustion Score (SEP) Total Score [0;54] A SEP < 17 reflects a low degree of burnout. A SEP between 18 and 29 indicates a moderate degree of burnout. A SEP over 30 indicates a high degree of burnout (red zone).
    • Depersonalization/Loss of Empathy Score (SD) Total Score [0;30] An SD < 5 reflects a low degree of depersonalization. An SD between 6 and 11 indicates a moderate degree of depersonalization. An SD greater than 12 indicates a high degree of loss of empathy (red zone).
    • Personal Accomplishment Score (SAP). Total Score [0;48] A SAP < 33 reflects a low degree of personal fulfillment (red zone). An SAP between 34 and 39 reflects a moderate degree of personal fulfillment. An SAP above 40 indicates a high degree of personal fulfillment.

    If both SAP and SD scores are in the red, the risk of Burn-out is very high, especially if the degree of personal fulfillment is also in the red.

    Measured: at inclusion

  11. Determine the profile of the smoker health professionals

    Data collection: gender, age, profession; level of dependence (Fagerstrom score); level of motivation to smoke and to use cannabis, if applicable (Richmond scale); and level of confidence in managing their patients' tobacco dependence.

    Measured: at inclusion

Timeline

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

  1. First posted25 May 2025
  2. Study start11 Nov 2024
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
* Interventional study * Prospective * Non-randomised * Comparative with historical cohort * Monocentric
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06988644
Sponsor's protocol ID
PSYTaB
Other IDs
2024-A01826-41
Acronym
PSYTaB
Status last verified
May 2025
First submitted
16 May 2025
Last updated
29 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing exhaled carbon monoxyde measurement in people with Smoking Cessation, run by Groupe Hospitalier Mutualiste de Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Estelle Cotte-Raffour, Nursery (0033 476708995, estelle.cotte-raffour@avec.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evalue the effectiveness of a counseling consultation in the workplace among smoker health professionals. (time frame: At 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.

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