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Not yet recruiting NCT07617766

Mindfulness Training in Type 2 Diabetes

No phase Interventional Type 2 Diabetes Mellitus (T2DM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness-Based Self-Management Education, Usual Care.
Who it may be relevant to
Registry conditions: Type 2 Diabetes Mellitus (T2DM). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Mindfulness-Based Self-Management Education
    A structured education program including mindfulness practices, diabetes self-management education, and group-based support sessions
  • Behavioral Usual Care
    Usual Care Control Group

Primary outcome measures

  • Change in self-management behavior score [Time frame: Baseline to 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Tortum State Hospital — Erzurum

Identifiers

NCT: NCT07617766 · AtaturkUnurse

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗