Type 2 Diabetes Mellitus (T2DM)MindfulT2DCANCT07617766
Mindfulness Training in Type 2 Diabetes
A study testing Mindfulness-Based Self-Management Education in people with Type 2 Diabetes Mellitus (T2DM), run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of mindfulness-based self-management education on diabetes-related difficulties and empowerment in individuals with type 2 diabetes. Participants will receive a structured education program designed to improve self-care behaviors, emotional well-being, and confidence in managing… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Mindfulness-Based Self-Management Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65 years.
- Diagnosed with Type 2 diabetes mellitus.
- Literate (able to read and write).
- Has access to and is able to actively use a smartphone or internet.
- No diagnosed mental or cognitive impairment.
- Willing to participate voluntarily and provide informed consent.
Who cannot join
- Previously received structured education related to their diabetes.
- Pregnant.
- Currently participating in another research study.
- Hospitalized due to diabetes-related complications.
- Unable to complete the education program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Tortum State Hospital
Erzurum, Tortum, 25430
Esmanur Günal, MSc, +905537066125, esmanurgunal2001@gmail.com
About this study
Official title: The Effect of Mindfulness-Based Self-Management Education on Diabetes-Related Difficulties and Empowerment in Individuals With Type 2 Diabetes
This study aims to evaluate the effects of mindfulness-based self-management education on diabetes-related difficulties and empowerment in individuals with type 2 diabetes. Participants will receive a structured education program designed to improve self-care behaviors, emotional well-being, and confidence in managing their condition.
The program includes mindfulness practices, diabetes self-management education, and supportive group sessions. Outcomes such as diabetes distress, self-management behaviors, and patient empowerment will be measured before and after the intervention.
The findings of this study are expected to contribute to improving patient-centered care and supporting individuals with type 2 diabetes in managing their health more effectively.
Read the detailed description
Type 2 diabetes is a chronic condition that requires continuous self-management, including medication adherence, lifestyle modification, and emotional coping. Many individuals experience diabetes-related difficulties, reduced motivation, and challenges in maintaining long-term self-care behaviors. Mindfulness-based approaches have been shown to improve emotional regulation, stress management, and self-efficacy in individuals with chronic illnesses.
This study is designed as a randomized controlled trial to evaluate the effectiveness of a mindfulness-based self-management education program in individuals with type 2 diabetes. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured program consisting of mindfulness practices, diabetes education, and group-based support sessions. The control group will receive usual care.
Primary outcomes include diabetes-related difficulties and patient empowerment. Secondary outcomes include self-care behaviors, emotional well-being, and perceived quality of life. Data will be collected at baseline and after completion of the intervention using validated assessment tools.
This study aims to provide evidence on whether integrating mindfulness into diabetes self-management education can improve both psychological and behavioral outcomes, thereby enhancing overall diabetes care and patient well-being.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Mindfulness-Based Self-Management Education, Usual Care
- Keywords
- Mindfulness, Type 2 diabetes, Self-management education, Patient empowerment, Behavioral intervention, Diabetes difficulties
- Medical subject headings
- Diabetes Mellitus, Type 2, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Self-Management EducationBehavioural
A structured education program including mindfulness practices, diabetes self-management education, and group-based support sessions
Usual CareBehavioural
Also called Standard diabetes care as provided by the healthcare system.
Usual Care Control Group
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Self-Management Education Group | Experimental | Participants will receive a structured mindfulness-based self-management education program in addition to usual care. Receives: Behavioral: Mindfulness-Based Self-Management Education |
| Usual Care Control Group | Active comparator | Participants will receive standard diabetes care without additional intervention. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-management behavior score
Measured using a validated self-management questionnaire
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startMay 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either a mindfulness-based self-management education group or a usual care control group.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Karaman, Ataturk University
- Investigators
- Seda Başak, PhD, Principal investigator, Atatürk University, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617766
- Sponsor's protocol ID
- AtaturkUnurse
- Acronym
- MindfulT2DCA
- Status last verified
- May 2026
- First submitted
- 11 Feb 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to confidentiality considerations and institutional data protection policies.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Self-Management Education on Diabetes-Related Difficulties and Empowerment in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07617766
- Acronym / sponsor ID
- MindfulT2DCA / AtaturkUnurse
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Mindfulness, Type 2 diabetes, Self-management education, Patient empowerment, Behavioral intervention, Diabetes difficulties
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Jun 2026 (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.
This study aims to evaluate the effects of mindfulness-based self-management education on diabetes-related difficulties and empowerment in individuals with type 2 diabetes. Participants will receive a structured education program designed to improve self-care behaviors, emotional well-being, and confidence in managing their condition.
The program includes mindfulness practices, diabetes self-management education, and supportive group sessions. Outcomes such as diabetes distress, self-management behaviors, and patient empowerment will be measured before and after the intervention.
The findings of this study are expected to contribute to improving patient-centered care and supporting individuals with type 2 diabetes in managing their health more effectively.
Detailed description
Type 2 diabetes is a chronic condition that requires continuous self-management, including medication adherence, lifestyle modification, and emotional coping. Many individuals experience diabetes-related difficulties, reduced motivation, and challenges in maintaining long-term self-care behaviors. Mindfulness-based approaches have been shown to improve emotional regulation, stress management, and self-efficacy in individuals with chronic illnesses.
This study is designed as a randomized controlled trial to evaluate the effectiveness of a mindfulness-based self-management education program in individuals with type 2 diabetes. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured program consisting of mindfulness practices, diabetes education, and group-based support sessions. The control group will receive usual care.
Primary outcomes include diabetes-related difficulties and patient empowerment. Secondary outcomes include self-care behaviors, emotional well-being, and perceived quality of life. Data will be collected at baseline and after completion of the intervention using validated assessment tools.
This study aims to provide evidence on whether integrating mindfulness into diabetes self-management education can improve both psychological and behavioral outcomes, thereby enhancing overall diabetes care and patient well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either a mindfulness-based self-management education group or a usual care control group.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Self-Management Education Group | Experimental | Behavioral: Mindfulness-Based Self-Management EducationParticipants will receive a structured mindfulness-based self-management education program in addition to usual care. |
| Usual Care Control Group | Active comparator | Behavioral: Usual CareParticipants will receive standard diabetes care without additional intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 65 years.
- Diagnosed with Type 2 diabetes mellitus.
- Literate (able to read and write).
- Has access to and is able to actively use a smartphone or internet.
- No diagnosed mental or cognitive impairment.
Key exclusion criteria (5 listed)
- Previously received structured education related to their diabetes.
- Pregnant.
- Currently participating in another research study.
- Hospitalized due to diabetes-related complications.
- Unable to complete the education program.
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 |
|---|---|---|
| Mindfulness-Based Self-Management EducationA structured education program including mindfulness practices, diabetes self-management education, and group-based support sessions | Behavioural | Mindfulness-Based Self-Management Education Group |
| Usual CareAlso: Standard diabetes care as provided by the healthcare system.Usual Care Control Group | Behavioural | Usual Care Control Group |
Primary outcome
Change in self-management behavior score
Time frame: Baseline to 8 weeks
Measured using a validated self-management questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to confidentiality considerations and institutional data protection policies.
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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.
Seda Başak, PhD principal investigator
Atatürk University, Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Self-Management Education in people with Type 2 Diabetes Mellitus (T2DM), run by Ataturk University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esmanur Günal, MSc (+905537066125, esmanurgunal2001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-management behavior score (time frame: Baseline to 8 weeks). 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 1 Jun 2026.