Contributions of Health Psychology to Support Patients With Diabetes Through Online Tools

NCT06194240 | Completed

• 1 other identifier: ULFFD
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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. 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. 2.To offer professionals alternatives to the traditional care of diabetic patients with the toolbox cited above.
3. 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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 12-Item Short Form Health Survey

  Quality of life. The minimum score is 0 (bad quality of life) and the maximum score is 100 (good quality of life).

  Before the intervention and six weeks after (when the program is finished)

Secondary Outcomes (6)

• Multidimensional Psychological Flexibility Inventory

  Before the intervention and six weeks after (when the program is finished)

• Hospital Anxiety and Depression Scale

  Before and after the intervention

• Basic Psychological Need Satisfaction and Frustration Scale

  Before the intervention and six weeks after (when the program is finished)

• Treatment Self-Regulation Questionnaire

  Before the intervention and six weeks after (when the program is finished)

• Diabetes Acceptance

  Before the intervention and six weeks after (when the program is finished)

Study Arms (3)

Slow ACT

EXPERIMENTAL

This group will follow an intervention online based on Acceptance and Commitment Therapy (ACT).

Behavioral: DiabACT

Slow Diabète

EXPERIMENTAL

This group will follow an online Slow Diabète (Slow Diabetes) program created by the French Federation of Diabetics.

Behavioral: DiabACT

No program

NO INTERVENTION

This group will not follow an online program, in order to do the comparaison.

Interventions

DiabACT BEHAVIORAL

E-program proposed to diabetic patients based on ACT therapy.

Slow ACT; Slow Diabète

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lorraine: lead

Study Sites (2)

University of Lorraine

Metz, 57000, France

Location

French Federation of Diabetics

Paris, 75011, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 8, 2024
• Study Start: September 1, 2021
• Primary Completion: April 24, 2023
• Study Completion: June 6, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)