DiabetesDiabACTNCT06194240
Contributions of Health Psychology to Support Patients With Diabetes Through Online Tools
A study testing DiabACT in people with Diabetes, run by University of Lorraine at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes
- What is being tested?
- DiabACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2021to 6 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
France2 sites
University of Lorraine
Metz, 57000
French Federation of Diabetics
Paris, 75011
About this study
Official title: Development of an E-program to Improve the Quality of Life of People With Diabetes Based on Acceptance and Commitment Therapy (ACT)
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.
Read more
This research project aims to:
- 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.
- To offer professionals alternatives to the traditional care of diabetic patients with the toolbox cited above.
- 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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- DiabACT
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiabACTBehavioural
E-program proposed to diabetic patients based on ACT therapy.
| Study group | Role | What they receive |
|---|---|---|
| Slow ACT | Experimental | This group will follow an intervention online based on Acceptance and Commitment Therapy (ACT). Receives: Behavioral: DiabACT |
| Slow Diabète | Experimental | This group will follow an online Slow Diabète (Slow Diabetes) program created by the French Federation of Diabetics. Receives: Behavioral: DiabACT |
| No program | No intervention | This group will not follow an online program, in order to do the comparaison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before the intervention and six weeks after (when the program is finished)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Before the intervention and six weeks after (when the program is finished)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Sep 2021
- Primary completion24 Apr 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Coline Hehn, University of Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194240
- Sponsor's protocol ID
- ULFFD
- Acronym
- DiabACT
- Status last verified
- Jan 2024
- First submitted
- 5 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an E-program to Improve the Quality of Life of People With Diabetes Based on Acceptance and Commitment Therapy (ACT)
- ClinicalTrials.gov ID
- NCT06194240
- Acronym / sponsor ID
- DiabACT / ULFFD
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of LorraineUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To offer professionals alternatives to the traditional care of diabetic patients with the toolbox cited above.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Slow ACT | Experimental | Behavioral: DiabACTThis group will follow an intervention online based on Acceptance and Commitment Therapy (ACT). |
| Slow Diabète | Experimental | Behavioral: DiabACTThis group will follow an online Slow Diabète (Slow Diabetes) program created by the French Federation of Diabetics. |
| No program | No intervention | –This group will not follow an online program, in order to do the comparaison. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiabACTE-program proposed to diabetic patients based on ACT therapy. | Behavioural | Slow ACT, Slow Diabète |
Primary outcome
12-Item Short Form Health Survey
Time frame: Before the intervention and six weeks after (when the program is finished)
Quality of life. The minimum score is 0 (bad quality of life) and the maximum score is 100 (good quality of life).
6 secondary outcomes
Multidimensional Psychological Flexibility Inventory
Time frame: Before the intervention and six weeks after (when the program is finished)
Hospital Anxiety and Depression Scale
Time frame: Before and after the intervention
Basic Psychological Need Satisfaction and Frustration Scale
Time frame: Before the intervention and six weeks after (when the program is finished)
Treatment Self-Regulation Questionnaire
Time frame: Before the intervention and six weeks after (when the program is finished)
Diabetes Acceptance
Time frame: Before the intervention and six weeks after (when the program is finished)
Generic Adherence Profile for Chronic Diseases
Time frame: Before the intervention and six weeks after (when the program is finished)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DiabACT in people with Diabetes, run by University of Lorraine at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-Item Short Form Health Survey (time frame: Before the intervention and six weeks after (when the program is finished)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024.