MindfulnessNCT07272304
Mindfulness-based Interventions on Stress, Anxiety, and Depression Symptoms in Diabetic Patients
A study testing Mindfullness exercises and Behavioral in people with Mindfulness and Anxiety, run by Emine Ergin at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mindfulness, Anxiety, Stress
- What is being tested?
- Mindfullness exercises and Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2021to 26 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Refusing to participate in the study
- Having communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Mindfulness, Anxiety, Stress, Depression Chronic, Diabetes Mellitus (Type 2)
- Being tested
- Mindfullness exercises, Behavioral
- Keywords
- anxiety, mindfulness, stress, depression, diabetes mellitus
- Medical subject headings
- Anxiety Disorders, Diabetes Mellitus, Type 2, Depression, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfullness exercisesOther
This 30-minute group therapy session will be provided online.
BehavioralBehavioural
This group 30-minute therapy session will be provided online.
| Study group | Role | What they receive |
|---|---|---|
| Mindfullness exercise group | Experimental | 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. Receives: Other: Mindfullness exercises; Behavioral: Behavioral |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
Personal Information Form: This form was developed based on literature. It includes sociodemographic data such as age, gender, educational status, etc.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 90. day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start8 Dec 2021
- Primary completion26 Jan 2022
- Study completion26 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emine Ergin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emine Ergin, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272304
- Sponsor's protocol ID
- SBU-EE2025-RCT
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-based Interventions on Stress, Anxiety, and Depression Symptoms in Diabetic Patients
- ClinicalTrials.gov ID
- NCT07272304
- Acronym / sponsor ID
- SBU-EE2025-RCT
- Conditions
- Mindfulness, Anxiety, Stress, Depression Chronic, Diabetes Mellitus (Type 2)
- Keywords
- anxiety, mindfulness, stress, depression, diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Emine ErginUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 26 Mar 2022 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfullness exercise group | Experimental | Other: Mindfullness exercises, Behavioral: BehavioralA 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. |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusing to participate in the study
- Having communication problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfullness exercisesThis 30-minute group therapy session will be provided online. | Other | Mindfullness exercise group |
| BehavioralThis group 30-minute therapy session will be provided online. | Behavioural | Mindfullness exercise group |
Primary outcome
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.
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).
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).
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.
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfullness exercises and Behavioral in people with Mindfulness and Anxiety, run by Emine Ergin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: 1. day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.