Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 4:21 AM
Study NCT ID:
NCT06398093
Status:
RECRUITING
Last Update Posted:
2024-07-17
First Post:
2024-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2024-04-28', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Compassion', 'timeFrame': '4 weeks', 'description': 'Will assess for change pre and post-intervention on standardized questionnaires on diabetes distress and self-compassion scores after the intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes', 'Diabetes Distress']}, 'descriptionModule': {'briefSummary': 'There is a high prevalence of anxiety and depression in patients with Type 2 Diabetes (T2D). While past studies demonstrate the potential therapeutic effect of mindfulness-based interventions in patients with T2D, little is understood about the mode of delivery or quantity of the intervention necessary to experience benefits. This project aims to develop and implement a self-compassion tool kit based on the principles of mindfulness and meditation to better understand how self-compassion works to affect psychological health and wellbeing in patients with T2D. The investigators will study the impact of a self-compassion tool kit - including mindfulness meditation, exercise, journaling and sleep parameters - on T2D. Enhancing emotional well-being could complement current T2D treatments to facilitate improved quality of life.', 'detailedDescription': 'A pre-test and post-test experimental design will be used to evaluate the efficacy of the self-compassion tool kit on distress, coping, testing glucose, sleep, and wellness in adults living with T2D.\n\nFor this 4-week study, participants will receive education on Sleep Hygiene practices during the first week of the intervention. Mindfulness meditation will be offered to participants using the Headspace app and four, ten-minute sessions will be prescribed per week. For exercise, 30-60 minutes of daily physical activity will be prescribed and participants can select the exercise of their choice. Additionally, participants will receive a journal in the mail with prompts associated with each day of required journalling. Prompts will elicit reflections, gratitude and growth. Participants will be followed by telephone every week. Baseline and week four data will be collected using the Demographic Form, T2DDAS, the Pittsburgh Sleep Quality Index (PSQI) and the SF-20. In addition, participants will be instructed to maintain a glucose testing, meditation, and exercise adherence log. The glucose testing log will permit measuring consistency and adherence to treatment over the course of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has type 2 diabetes\n* Has a score above 2 on the T2D Distress Assessment Scale\n\nExclusion Criteria:\n\n* Does not have type 2 diabetes\n* Has a score above 2 on the T2D Distress Assessment Scale\n* Cannot safely exercise\n* Cannot complete the requested tasks'}, 'identificationModule': {'nctId': 'NCT06398093', 'briefTitle': 'Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '810394'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-Compassion Toolkit', 'interventionNames': ['Behavioral: Self-Compassion Tool Kit']}], 'interventions': [{'name': 'Self-Compassion Tool Kit', 'type': 'BEHAVIORAL', 'description': 'Participants will mediate, journal their reactions, exercise, and apply sleep hygiene measures over the course of four weeks.', 'armGroupLabels': ['Self-Compassion Toolkit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amalia Axinn, BA', 'role': 'CONTACT', 'email': 'aaxinn@health.ucsd.edu'}, {'name': 'Edward Chao, DO', 'role': 'CONTACT', 'email': 'ecchao@health.ucsd.edu', 'phone': '619-400-5050', 'phoneExt': 'Chao'}, {'name': 'Edward C Chao, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Amalia Axinn, BS', 'role': 'CONTACT', 'email': 'aaxinn@health.ucsd.edu', 'phone': '6194005050'}, {'name': 'Edward C Chao, DO', 'role': 'CONTACT', 'email': 'ecchao@health.ucsd.edu', 'phone': '619-400-5050'}], 'overallOfficials': [{'name': 'Edward C Chao, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '6 months after the study, up to 1 yr after.', 'ipdSharing': 'YES', 'description': 'Considering sharing with other researchers.', 'accessCriteria': 'To be determined.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Edward Chao', 'investigatorAffiliation': 'University of California, San Diego'}}}}