An interventional study of DiabACT in Diabetes, sponsored by University of Lorraine. Completed at 2 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-01-08.
Sponsored by University of Lorraine · Not applicable, Interventional, and Health services research
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:
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 300 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Lorraine is the lead sponsor of 12 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
This group will follow an intervention online based on Acceptance and Commitment Therapy (ACT).
Behavioral: DiabACT
This group will follow an online Slow Diabète (Slow Diabetes) program created by the French Federation of Diabetics.
Behavioral: DiabACT
This group will not follow an online program, in order to do the comparaison.
E-program proposed to diabetic patients based on ACT therapy.
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).
Time frame: Before the intervention and six weeks after (when the program is finished)
Multidimensional Psychological Flexibility Inventory
Psychological Flexibility. This scale is divided into twelve categories, based on functional and dysfunctional processes. For functional processes, the closer the average score is to 7, the more correct is the participant's process. On the other hand, for dysfunctional processes, if the average score is close to 7, then the process is truly dysfunctional.
Time frame: Before the intervention and six weeks after (when the program is finished)
Hospital Anxiety and Depression Scale
Anxiety and Depression. The total score ranges from 0 to 21 for each category (depression or anxiety). A score of 10 or more indicates definite symptomatology.
Time frame: Before and after the intervention
Basic Psychological Need Satisfaction and Frustration Scale
Basic psychological needs. The score is divided into six categories, according to the satisfaction or frustration of one of the three basic psychological needs. When it comes to satisfaction, the closer the score is to seven, the better it is. If the score is close to seven for frustration items, then the latter will be high.
Time frame: Before the intervention and six weeks after (when the program is finished)
Treatment Self-Regulation Questionnaire
Motivation towards treatments. Two scores are given for this 19-item scale. One for autonomous motivation, with average scores ranging from 0 (no autonomous motivation) to 7 (strong autonomous motivation) with 8 items. And another for controlled motivation, with average scores ranging from 0 (no controlled motivation) to 7 (high controlled motivation) on 11 items.
Time frame: Before the intervention and six weeks after (when the program is finished)
Diabetes Acceptance
Diabetes Acceptance and Action Scale - revised. The scale is a 9-point measure of diabetes acceptance. It is based on a five-point Likert scale ranging from never true (0) to always true (4). Higher scores mean greater acceptance and greater ability to adapt to diabetes.
Time frame: Before the intervention and six weeks after (when the program is finished)
Generic Adherence Profile for Chronic Diseases
Therapeutic adherence. The questionnaire consists of 32 items covering three components of health adherence: medication and/or medical adherence, lifestyle adherence and diet adherence. Some items measure non-adherence to therapy (items 2 and 6 to 16) and others measure adherence to therapy. Responses to the items were rated on a 4-point Likert-type scale (1, never, to 4, all the time).
Time frame: Before the intervention and six weeks after (when the program is finished)
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of Lorraine