Clinical trial NCT06194240: Contributions of Health Psychology to Support Patients With Diabetes Through Online Tools
Official title: Development of an E-program to Improve the Quality of Life of People With Diabetes Based on Acceptance and Commitment Therapy (ACT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: University of Lorraine
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: With over 4 million people living with diabetes in France, i.e. 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 patient's 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.

Eligibility criteria: Inclusion Criteria:

* Participants must be aged 18 and over,
* To live with type 1 diabetes (T1D) or type 2 diabetes (T2D),
* Be French,
* Living in France
* Understand and accept the constraints of the study,
* Have given their consent after having read the terms of the study,
* Be affiliated to social security.

Exclusion Criteria:

* Lack of autonomy making it impossible to complete the online questionnaire,
* Members of the "Slow Diabetes" group cannot have benefited from the "Slow ACT" program,
* Persons deprived of their rights, persons under guardianship.

Age, type of diabetes or gender are not inclusion criteria, but will be controlled for in the statistical analyses, along with other socio-demographic variables (i.e. level of education, socio-economic level).

Primary outcomes:
measure: 12-Item Short Form Health Survey
timeFrame: Before the intervention and six weeks after (when the program is finished)
Secondary outcomes:
measure: Multidimensional Psychological Flexibility Inventory
timeFrame: Before the intervention and six weeks after (when the program is finished)
measure: Hospital Anxiety and Depression Scale
timeFrame: Before and after the intervention
measure: Basic Psychological Need Satisfaction and Frustration Scale
timeFrame: Before the intervention and six weeks after (when the program is finished)
measure: Treatment Self-Regulation Questionnaire
timeFrame: Before the intervention and six weeks after (when the program is finished)
measure: Diabetes Acceptance
timeFrame: Before the intervention and six weeks after (when the program is finished)
measure: Generic Adherence Profile for Chronic Diseases
timeFrame: Before the intervention and six weeks after (when the program is finished)
Other outcomes:
Locations:
city: Metz
country: France
facility: University of Lorraine
city: Paris
country: France
facility: French Federation of Diabetics
Study officials:
References: