Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500117
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Digital Mindfulness Training Programme for Smoking Cessation and Maintenance
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
Official Title:
Digital Mindfulness Training Programme for Smoking Cessation and Maintenance A Mixed-method Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HowToMind
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 188 95 CI 104 340 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 Whats 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 dAppui 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
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 188 95 CI 104 340 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 Whats 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 dAppui 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None