Mindfulness Training in Type 2 Diabetes

NCT07617766 | Not Yet Recruiting

• 1 other identifier: AtaturkUnurse
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

Mindfulness; Type 2 diabetes; Self-management education; Patient empowerment; Behavioral intervention; Diabetes difficulties

Outcome Measures

Primary Outcomes (1)

• Change in self-management behavior score

  Measured using a validated self-management questionnaire

  Baseline to 8 weeks

Study Arms (2)

Mindfulness-Based Self-Management Education Group

EXPERIMENTAL

Participants will receive a structured mindfulness-based self-management education program in addition to usual care.

Behavioral: Mindfulness-Based Self-Management Education

Usual Care Control Group

ACTIVE COMPARATOR

Participants will receive standard diabetes care without additional intervention.

Behavioral: Usual Care

Interventions

Mindfulness-Based Self-Management Education BEHAVIORAL

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

Mindfulness-Based Self-Management Education Group

Usual Care BEHAVIORAL

Usual Care Control Group

Also known as: Standard diabetes care as provided by the healthcare system.

Usual Care Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Tortum State Hospital

Erzurum, Tortum, 25430, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Patient Participation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Seda Başak, PhD

  Atatürk University, Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esmanur Günal, MSc

CONTACT

+905537066125; esmanurgunal2001@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to either a mindfulness-based self-management education group or a usual care control group.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: June 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)