Mindfulness-based Interventions on Stress, Anxiety, and Depression Symptoms in Diabetic Patients

NCT ID: NCT07272304

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-08

Study Completion Date

2022-03-26

Brief Summary

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The study was conducted at a private hospital in Istanbul, Turkey, as a randomized controlled experimental trial with a pretest-posttest approach. The study included 70 patients in each group, for a total of 140 patients. Necessary institutional and ethical approvals were obtained. Participants were assigned to the experimental and control groups according to a randomization list previously prepared by the researchers. Data collection was conducted online using Google Forms, and interviews were conducted using Zoom. Participant Information Form, Perceived Stress Scale, Beck Depression Inventory, and Beck Anxiety Inventory were used.

Detailed Description

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Conditions

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Mindfulness Anxiety Stress Depression Chronic Diabetes Mellitus (Type 2)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Participants were assigned to experimental and control groups based on a previously prepared randomization list prepared by the researchers. Before assignment, caregivers will be contacted online to inform them about the study and obtain their consent. Data collection was conducted online using Google Forms, and interviews were conducted using Zoom.

Study Groups

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Mindfullness exercise group

A 30-minute therapy session will be provided online by a therapist certified in mindfullness exercise. Following the session, participants will complete the Participant Information Form, Perceived Stress Scale, Beck Depression Inventory, and Beck Anxiety Inventory.

Group Type EXPERIMENTAL

Mindfullness exercises

Intervention Type OTHER

This 30-minute group therapy session will be provided online.

Behavioral

Intervention Type BEHAVIORAL

This group 30-minute therapy session will be provided online.

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfullness exercises

This 30-minute group therapy session will be provided online.

Intervention Type OTHER

Behavioral

This group 30-minute therapy session will be provided online.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Must be 18 years or older and agree to participate in the study.
* Must be cooperative and have no communication problems.
* Must have been diagnosed with diabetes for at least one month.
* Must not have taken or practiced any courses on coping with anxiety, tension, or stress.

Exclusion Criteria

* Refusing to participate in the study
* Having communication problems
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emine Ergin

OTHER

Sponsor Role lead

Responsible Party

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Emine Ergin

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Health Science University

Istanbul, Üsküdar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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SBU-EE2025-RCT

Identifier Type: -

Identifier Source: org_study_id

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