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

November 26, 2025 updated by: Emine Ergin

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Turkey (Türkiye)
    • Üsküdar
      • Istanbul, Üsküdar, Turkey (Türkiye)
        • Health Science University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control group
Experimental: 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.
Other: Mindfullness exercises
This 30-minute group therapy session will be provided online.
Behavioral: Behavioral
This group 30-minute therapy session will be provided online.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Personal Information Form
Time Frame: 1. day
Personal Information Form: This form was developed based on literature. It includes sociodemographic data such as age, gender, educational status, etc.
1. day
he Perceived Stress Scale
Time Frame: 1. day
The Perceived Stress Scale was developed by Cohen, Kamarck, and Mermelstein (1983). The Perceived Stress Level Scale, consisting of 14 items, is designed to measure the degree to which a person perceives certain situations in their life as stressful. The scale is a 5-point Likert-type scale, with each item ranging from "Never (0)" to "Very often (4)." Seven of the items are positively worded and are reverse-scored. Standardization studies for the scale's use in Turkey were conducted by Baltaş et al. (1998). The total score obtained from the scale indicates an individual's stress level. Scores between 11 and 26 indicate low stress, scores between 27 and 41 indicate moderate stress, and scores between 42 and 56 indicate high stress (Baltaş et al., 1998).
1. day
The Perceived Stress Scale
Time Frame: 90. day
The Perceived Stress Scale was developed by Cohen, Kamarck, and Mermelstein (1983). The Perceived Stress Level Scale, consisting of 14 items, is designed to measure the degree to which a person perceives certain situations in their life as stressful. The scale is a 5-point Likert-type scale, with each item ranging from "Never (0)" to "Very often (4)." Seven of the items are positively worded and are reverse-scored. Standardization studies for the scale's use in Turkey were conducted by Baltaş et al. (1998). The total score obtained from the scale indicates an individual's stress level. Scores between 11 and 26 indicate low stress, scores between 27 and 41 indicate moderate stress, and scores between 42 and 56 indicate high stress (Baltaş et al., 1998).
90. day
Beck Depression Inventory
Time Frame: 1. day
Beck Depression Inventory: Developed by Beck, this scale is used to determine individuals' risk for depression and to measure the level and severity of depression symptoms. The Turkish validity and reliability of the scale was conducted by Hisli. The 21-item scale provides a four-point Likert-type measurement. Each item on the scale receives a progressively increasing score from 0 to 3, and the total score ranges from 0 to 63. A higher total score is considered an indicator of more severe depression. In the validity and reliability study of the BDI, scores obtained from the BDI were interpreted as follows: 0-13 points indicating no depression; 14-19 points indicating low depression; 20-18 points indicating moderate depression; and 29-63 points indicating high depression.
1. day
Beck Depression Inventory
Time Frame: 90. day
Beck Depression Inventory: Developed by Beck, this scale is used to determine individuals' risk for depression and to measure the level and severity of depression symptoms. The Turkish validity and reliability of the scale was conducted by Hisli. The 21-item scale provides a four-point Likert-type measurement. Each item on the scale receives a progressively increasing score from 0 to 3, and the total score ranges from 0 to 63. A higher total score is considered an indicator of more severe depression. In the validity and reliability study of the BDI, scores obtained from the BDI were interpreted as follows: 0-13 points indicating no depression; 14-19 points indicating low depression; 20-18 points indicating moderate depression; and 29-63 points indicating high depression.
90. day
Beck Anxiety Inventory (BAI)
Time Frame: 1. day
Beck Anxiety Inventory (BAI): Developed by Beck et al., the Beck Anxiety Inventory (BAI) is a self-report instrument used to determine the frequency of anxiety symptoms experienced by individuals. The 21-item scale is a 4-point Likert-type scale scored from 0 to 3. Based on BAI scores, patients' anxiety levels are classified as follows: 0-17 points indicate low anxiety, 18-24 points indicate moderate anxiety, and 25 and above indicate high anxiety. Higher values from the total scale indicate higher anxiety levels, while lower values indicate lower anxiety levels. Adapted to Turkish by Ulusoy, the original version of the scale reported a Cronbach's alpha internal consistency coefficient of 0.92, and test-retest reliability coefficients of r=0.75 and r=0.67. In the adaptation study conducted in Turkey, the Cronbach's alpha internal consistency coefficient was reported as 0.93, and test-retest reliability was reported as 0.57. It is stated that the item total correlation coefficients
1. day
Beck Anxiety Inventory (BAI)
Time Frame: 90. day
Beck Anxiety Inventory (BAI): Developed by Beck et al., the Beck Anxiety Inventory (BAI) is a self-report instrument used to determine the frequency of anxiety symptoms experienced by individuals. The 21-item scale is a 4-point Likert-type scale scored from 0 to 3. Based on BAI scores, patients' anxiety levels are classified as follows: 0-17 points indicate low anxiety, 18-24 points indicate moderate anxiety, and 25 and above indicate high anxiety. Higher values from the total scale indicate higher anxiety levels, while lower values indicate lower anxiety levels. Adapted to Turkish by Ulusoy, the original version of the scale reported a Cronbach's alpha internal consistency coefficient of 0.92, and test-retest reliability coefficients of r=0.75 and r=0.67. In the adaptation study conducted in Turkey, the Cronbach's alpha internal consistency coefficient was reported as 0.93, and test-retest reliability was reported as 0.57. It is stated that the item total correlation coefficients
90. day

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emine Ergin

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SBU-EE2025-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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