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.
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
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Anastasia DEMINA, 0380293524 ext. +33, anastasia.demina@chu-dijon.fr
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.
- Conditions
- Smoking-related Disorder
- 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 group | Role | What they receive |
|---|---|---|
| patient | Experimental | Not 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.
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.
- First posted15 Jul 2024
- Study start1 Jul 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking-related DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Mindfulness Training Programme for Smoking Cessation and Maintenance A Mixed-method Pilot Study
- ClinicalTrials.gov ID
- NCT06500117
- Acronym / sponsor ID
- HowToMind / DEMINA IReSP/INCa 2023
- Conditions
- Smoking-related Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Other: eMind application, Other: questionnaires, Other: focus groupe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eMind applicationlearning phase accompanied by application for 8 weeks, then independent practical application phases | Other | patient |
| questionnairesVisual Analogue Scale VAS ("craving") and Mobile Application Rating Scale MARS-F | Other | patient |
| focus groupePatients 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. | Other | patient |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 39977412Demina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.