Mindfulness Training in Type 2 Diabetes (MindfulT2DCA)

May 24, 2026 updated by: Seda Karaman, Ataturk University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Based Self-Management Education Group
Participants will receive a structured mindfulness-based self-management education program in addition to usual care.
Behavioral: Mindfulness-Based Self-Management Education
A structured education program including mindfulness practices, diabetes self-management education, and group-based support sessions
Active Comparator: Usual Care Control Group
Participants will receive standard diabetes care without additional intervention.
Behavioral: Usual Care
Usual Care Control Group
Other Names:
  • Standard diabetes care as provided by the healthcare system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-management behavior score
Time Frame: Baseline to 8 weeks
Measured using a validated self-management questionnaire
Baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Principal Investigator: Seda Başak, PhD, Atatürk University, Faculty of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

May 24, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 24, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AtaturkUnurse

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to confidentiality considerations and institutional data protection policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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