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Smoking-related DisorderHowToMindNCT06500117

Digital Mindfulness Training Programme for Smoking Cessation and Maintenance

A study testing eMind application, questionnaires and focus groupe in people with Smoking-related Disorder, run by Centre Hospitalier Universitaire Dijon 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

Although there are several effective medicinal approaches for smoking cessation, relapses are frequent and the proportion of people who remain abstinent is low (around 15-25% 6 months after withdrawal). New approaches are therefore needed to make it easier to stop smoking. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking-related Disorder
What is being tested?
eMind application, questionnaires and focus groupe
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteFrance
Study dates
1 Jul 2024to Oct 2027
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

  • Person who has given oral consent
  • Adult aged 18 and over
  • Smoker with a smoking-related disorder according to DSM-5 criteria
  • Motivated to stop smoking
  • With daily access to a smartphone
  • Able to understand spoken and written French

Who cannot join

  • Person subject to a legal protection measure (curatorship, guardianship)
  • Persons under court order
  • People with cognitive problems that prevent mindfulness training
  • Currently using other smoking cessation treatments (burpropion, varenicline) except NRT
  • suffering from an acute psychiatric or somatic disorder requiring hospitalisation / not stabilised
  • With a contraindication to nicotine replacement therapy
Show all 9Show fewer
  • With an alcohol use disorder or using illicit substances
  • Anyone who is pregnant, breastfeeding or planning to become pregnant in the next 6 months
  • Not affiliated to national health insurance

Trial locations and contacts

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

France1 site, 1 recruiting
  • Chu Dijon Bourgogne

    Dijon, 21000

    Anastasia DEMINA, 0380293524 ext. +33, anastasia.demina@chu-dijon.fr

    Recruiting

Other trials in France

About this study

Official title: Digital Mindfulness Training Programme for Smoking Cessation and Maintenance A Mixed-method Pilot Study

Although there are several effective medicinal approaches for smoking cessation, relapses are frequent and the proportion of people who remain abstinent is low (around 15-25% 6 months after withdrawal). New approaches are therefore needed to make it easier to stop smoking.

Mindfulness-based interventions (MBIs) are effective in depression, stress reduction and chronic pain (Goldberg et al., 2017, Khoury et al., 2015, Hilton et al., 2017). There is also evidence of efficacy in smoking cessation with a relative risk of 1.88 95% CI [1.04; 3.40] of abstinence at 17 to 24 weeks after MBI (Oikonomou, 2016).

Read more

Typically, MBIs take the form of 8-week programmes with weekly group sessions. However, many patients are not able to attend a full 8-week programme. In addition, these programmes are only accessible to a small number of patients due to the lack of trained professionals and the out-of-pocket costs.

In response to these limitations, smartphone applications have been developed and evaluated, but none has been shown to be effective in smoking cessation. What's more, none of the evaluated applications offered the equivalent of a conventional 8-week MBI.

Furthermore, it has now been demonstrated in the international literature that involving patients, service users and relatives in the development and conduct of health research projects has become a means of achieving effective, high-quality integration of healthcare (Fusco, 2020) as well as improving the overall quality of health research (Shen, 2017). When PUPs are involved not as research subjects but as research partners in the health research process, this can lead to "significant changes in outcomes for patients and health systems, and the realignment of research processes and outcomes to be patient-centred" (Bird, 2020).

The involvement of PUPs has become a requirement of many funding programmes and journals, as well as an international health policy priority.

We are therefore developing an eMind application - the first electronic MBI for smoking cessation that allows patients to follow a complete 8-week programme and that recreates the conditions of a classic MBI as closely as possible. The application will be available on the EXOLIS platform. This platform is offered by the Agence Régionale de Santé Bourgogne - Franche Comté in partnership with GRADeS (Groupement Régional d'Appui au Développement de la eSanté).

The eMind application will be co-constructed: it will be based on a research partnership involving patients. An initial version of the content has been created in the university hospital addictionology department by healthcare professionals trained in mindfulness. This first version of the application - a beta version - will be modified according to the feedback received from patients. To reward their contribution to the final version of the application, patients will be compensated in the form of a gift card. Once the changes have been taken into account, a feedback session will be organised to present the results of the study and the new version of eMind.

Being tested
eMind application, questionnaires, focus groupe

What participants receive

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

  • eMind applicationOther

    learning phase accompanied by application for 8 weeks, then independent practical application phases

  • questionnairesOther

    Visual Analogue Scale VAS ("craving") and Mobile Application Rating Scale MARS-F

  • focus groupeOther

    Patients who so wish will be able to give us more detailed feedback on the application. The focus groups will be carried out between visit 3 and visit 4.

Study groups in NCT06500117
Study groupRoleWhat they receive
patientExperimentalNot described
Receives: Other: eMind application; Other: questionnaires; Other: focus groupe

What is being measured

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

  1. The acceptability of the beta version of eMind will be assessed by how regularly it is used.

    Based on the rhythm of the videos and audio provided by the application, we will define people who use eMind at least 4 times a week for 8 weeks as active users, those who use the application 1 to 3 times a week as occasional users, and those who no longer use the application after 8 weeks as users who have given up using the application.

    Measured: Usability will be assessed after 8 weeks' use of the application.

Timeline

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

  1. First posted15 Jul 2024
  2. Study start1 Jul 2024
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2027 (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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06500117
Sponsor's protocol ID
DEMINA IReSP/INCa 2023
Acronym
HowToMind
Status last verified
Apr 2026
First submitted
8 Jul 2024
Last updated
29 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Demina A, Soudry-Faure A, Petit B, Meunier-Beillard N, Trojak B. Usability of a digital mindfulness training program for smoking cessation: A mixed-method single-center pilot study protocol (HowToMind). PLoS One. 2025 Feb 20;20(2):e0318686. doi: 10.1371/journal.pone.0318686. eCollection 2025.

    PubMed 39977412

Questions about this trial

What is this clinical trial studying?

A study testing eMind application, questionnaires and focus groupe in people with Smoking-related Disorder, run by Centre Hospitalier Universitaire Dijon 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 6 inclusion and 9 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 Apr 2026. 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 Anastasia DEMINA (0380293524 ext. +33, anastasia.demina@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The acceptability of the beta version of eMind will be assessed by how regularly it is used. (time frame: Usability will be assessed after 8 weeks' use of the application.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06500117, which also lists 1 linked publication.

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 Apr 2026.

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