Digital Mindfulness Training Programme for Smoking Cessation and Maintenance

NCT06500117 | Recruiting

• 1 other identifier: DEMINA IReSP/INCa 2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Smoking-related Disorder

Outcome Measures

Primary Outcomes (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.

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

Study Arms (1)

patient

EXPERIMENTAL

Other: eMind application; Other: questionnaires; Other: focus groupe

Interventions

eMind application OTHER

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

patient

questionnaires OTHER

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

patient

focus groupe OTHER

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.

patient

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 39977412 DERIVED

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Anastasia DEMINA

CONTACT

0380293524; anastasia.demina@chu-dijon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

FR (1)