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

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: Completed
• Conditions: Stress; Anxiety; Mindfulness; Depression Chronic; Diabetes Mellitus (Type 2)
• Intervention / Treatment: Other: Mindfullness exercises; Behavioral: Behavioral

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Personal Information Form	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	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	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	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	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)	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)	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

• Sponsor: Emine Ergin

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2021
• Primary Completion (Actual): January 26, 2022
• Study Completion (Actual): March 26, 2022

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: depression; anxiety; mindfulness; stress; diabetes mellitus
• Additional Relevant MeSH Terms: Endocrine System Diseases; Mental Disorders; Metabolic Diseases; Behavioral Symptoms; Glucose Metabolism Disorders; Behavior; Nutritional and Metabolic Diseases; Anxiety Disorders; Diabetes Mellitus, Type 2; Depression; Diabetes Mellitus
• Other Study ID 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