Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT07272304
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2025-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mindfulness-based Interventions on Stress, Anxiety, and Depression Symptoms in Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '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.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2022-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Personal Information Form', 'timeFrame': '1. day', 'description': 'Personal Information Form: This form was developed based on literature. It includes sociodemographic data such as age, gender, educational status, etc.'}, {'measure': 'he Perceived Stress Scale', 'timeFrame': '1. day', 'description': '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).'}, {'measure': 'The Perceived Stress Scale', 'timeFrame': '90. day', 'description': '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).'}, {'measure': 'Beck Depression Inventory', 'timeFrame': '1. day', 'description': "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."}, {'measure': 'Beck Depression Inventory', 'timeFrame': '90. day', 'description': "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."}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '1. day', 'description': "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"}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': '90. day', 'description': "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"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anxiety', 'mindfulness', 'stress', 'depression', 'diabetes mellitus'], 'conditions': ['Mindfulness', 'Anxiety', 'Stress', 'Depression Chronic', 'Diabetes Mellitus (Type 2)']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be 18 years or older and agree to participate in the study.\n* Must be cooperative and have no communication problems.\n* Must have been diagnosed with diabetes for at least one month.\n* Must not have taken or practiced any courses on coping with anxiety, tension, or stress.\n\nExclusion Criteria:\n\n* Refusing to participate in the study\n* Having communication problems'}, 'identificationModule': {'nctId': 'NCT07272304', 'briefTitle': 'Mindfulness-based Interventions on Stress, Anxiety, and Depression Symptoms in Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'The Effect of Mindfulness-based Interventions on Stress, Anxiety, and Depression Symptoms in Diabetic Patients', 'orgStudyIdInfo': {'id': 'SBU-EE2025-RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfullness exercise group', 'description': '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.', 'interventionNames': ['Other: Mindfullness exercises', 'Behavioral: Behavioral']}, {'type': 'NO_INTERVENTION', 'label': 'control group'}], 'interventions': [{'name': 'Mindfullness exercises', 'type': 'OTHER', 'description': 'This 30-minute group therapy session will be provided online.', 'armGroupLabels': ['Mindfullness exercise group']}, {'name': 'Behavioral', 'type': 'BEHAVIORAL', 'description': 'This group 30-minute therapy session will be provided online.', 'armGroupLabels': ['Mindfullness exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Üsküdar', 'country': 'Turkey (Türkiye)', 'facility': 'Health Science University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emine Ergin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Emine Ergin', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}