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NCT Number: NCT07617766

Mindfulness Training in 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-Based Self-Management Education

Behavioral

A structured education program including mindfulness practices, diabetes self-management education, and group-based support sessions

Usual Care

Behavioral

Usual Care Control Group

Other names: Standard diabetes care as provided by the healthcare system.

Primary outcomes

  1. Change in self-management behavior score

    Time frame: Baseline to 8 weeks

    Measured using a validated self-management questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Esmanur Günal, MSc

CONTACT

[email protected]

+905537066125

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Effect of Mindfulness-Based Self-Management Education on Diabetes-Related Difficulties and Empowerment in Individuals With Type 2 Diabetes

Acronym: MindfulT2DCA

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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