Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06194240
Status:
COMPLETED
Last Update Posted:
2024-01-08
First Post:
2023-12-05
Brief Title:
Contributions of Health Psychology to Support Patients With Diabetes Through Online Tools
Sponsor:
University of Lorraine
Organization:
University of Lorraine
Study Overview
Official Title:
Development of an E-program to Improve the Quality of Life of People With Diabetes Based on Acceptance and Commitment Therapy ACT
Status:
COMPLETED
Status Verified Date:
2024-01
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:
DiabACT
Brief Summary:
With over 4 million people living with diabetes in France ie 6 of the general population it is necessary to consider both their physical and mental health Indeed recent studies have shown that with a good quality of life patients have better disease management improved physical health and social life and reduced anxiety and depressive symptoms
Quality of life is at the heart of this research project In order to improve it several psychotherapies can be used notably those that include mindfulness Of all those proposed in the literature Acceptance and Commitment Therapy ACT developed by Hayes appears to be ideally suited to this objective The aim of this psychotherapy is to improve the patients psychological flexibility According to the scientific literature ACT therapy has been shown to improve the quality of life of patients living with diabetes as well as their ability to manage their condition and reduce anxiety and depressive symptoms
This research project aims to
1 To help patients cope better with their illness through learning the different dimensions of ACT therapy in order to obtain a toolbox to use on a daily basis when necessary
2 To offer professionals alternatives to the traditional care of diabetic patients with the toolbox cited above
3 To enable health authorities to take advantage of this program and these different exercises to reduce complications in the medium and long term for people with diabetes and change health behaviors
In 2020 the French Diabetics Federation created the Slow Diabetes movement The initial objective of which was to help people with diabetes to better cope with their isolation linked to the Covid-19 pandemic Since its launch this movement has taken the form of several programs lasting three or six weeks and developed to improve the general well-being of people with diabetes
The research proposed here seeks to improve the quality of life of diabetic patients through online ACT therapy based on the Slow Diabetes model
Quality of life is at the heart of this research project In order to improve it several psychotherapies can be used notably those that include mindfulness Of all those proposed in the literature Acceptance and Commitment Therapy ACT developed by Hayes appears to be ideally suited to this objective The aim of this psychotherapy is to improve the patients psychological flexibility According to the scientific literature ACT therapy has been shown to improve the quality of life of patients living with diabetes as well as their ability to manage their condition and reduce anxiety and depressive symptoms
This research project aims to
1 To help patients cope better with their illness through learning the different dimensions of ACT therapy in order to obtain a toolbox to use on a daily basis when necessary
2 To offer professionals alternatives to the traditional care of diabetic patients with the toolbox cited above
3 To enable health authorities to take advantage of this program and these different exercises to reduce complications in the medium and long term for people with diabetes and change health behaviors
In 2020 the French Diabetics Federation created the Slow Diabetes movement The initial objective of which was to help people with diabetes to better cope with their isolation linked to the Covid-19 pandemic Since its launch this movement has taken the form of several programs lasting three or six weeks and developed to improve the general well-being of people with diabetes
The research proposed here seeks to improve the quality of life of diabetic patients through online ACT therapy based on the Slow Diabetes model
Detailed Description:
The aim of this detailed description is to present the research protocol of a controlled randomized trial to evaluate the impact of an e-program based on Acceptance and Commitment Therapy ACT for people living with diabetes in France on the quality of life and the psychological flexibility
The recruitment of participants is done through a call for participation launched by the French Federation of Diabetics during which patients have access to a Patient Information Notice PIN presenting the project This PIN enable diabetic patients to find out about the different possible groups of the study and the planned randomization In this way they will know that they can belong to three different groups 1 The Slow ACT intervention group which will follow an intervention based on acceptance and commitment therapy duration 6 weeks 2 The Slow Diabetes control group which will follow a Slow Diabète Summer program duration 5 weeks - launched by the French Federation of Diabetics 3 The No program control group which will not follow either of the two interventions and will be able to compare the data from the two groups presented above
Finally 15 of the people in the ACT intervention group were voluntarily recruited to a Single Case protocol This took place over 14 weeks with 14 measures psychological flexibility and quality of life
The content of the e-program ACT in which not all patients have participated is sent to all of the participants of the study at the end of it for reasons of ethics and fairness
The recruitment of participants is done through a call for participation launched by the French Federation of Diabetics during which patients have access to a Patient Information Notice PIN presenting the project This PIN enable diabetic patients to find out about the different possible groups of the study and the planned randomization In this way they will know that they can belong to three different groups 1 The Slow ACT intervention group which will follow an intervention based on acceptance and commitment therapy duration 6 weeks 2 The Slow Diabetes control group which will follow a Slow Diabète Summer program duration 5 weeks - launched by the French Federation of Diabetics 3 The No program control group which will not follow either of the two interventions and will be able to compare the data from the two groups presented above
Finally 15 of the people in the ACT intervention group were voluntarily recruited to a Single Case protocol This took place over 14 weeks with 14 measures psychological flexibility and quality of life
The content of the e-program ACT in which not all patients have participated is sent to all of the participants of the study at the end of it for reasons of ethics and fairness
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