Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-30 @ 2:02 AM
Study NCT ID:
NCT02675257
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2016-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depression and Diabetes Control Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'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': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-27', 'studyFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2016-02-04', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inflammatory Marker: hsCRP', 'timeFrame': '12 months', 'description': 'Mean difference between hsCRP scores at baseline and at 12 month follow'}, {'measure': 'Inflammatory Marker: IL-6', 'timeFrame': '12 months', 'description': 'Mean difference between IL-6 scores at baseline and at 12 month follow'}, {'measure': 'Inflammatory Marker: IL-18', 'timeFrame': '12 months', 'description': 'Mean difference between IL-18 scores at baseline and at 12 month follow'}, {'measure': 'Inflammatory Marker: IL-1Ra', 'timeFrame': '12 months', 'description': 'Mean difference between IL-1Ra scores at baseline and at 12 month follow'}, {'measure': 'Inflammatory Marker: MCP-1', 'timeFrame': '12 months', 'description': 'Mean difference between MCP-1 scores at baseline and at 12 month follow'}, {'measure': 'Inflammatory Marker: Adiponectin', 'timeFrame': '12 months', 'description': 'Mean difference between Adiponectin scores at baseline and at 12 month follow'}], 'primaryOutcomes': [{'measure': 'Improvement of glycaemic control as measured by the HbA1c', 'timeFrame': '12 months', 'description': 'Mean difference between HbA1c values at baseline and at 12 month follow'}], 'secondaryOutcomes': [{'measure': "Improvement of glycaemic control as measured by participants' blood glucose meter or glucose monitoring devices (data are extracted from tools using the diasend application)", 'timeFrame': '12 months', 'description': 'Mean difference between average glucose test scores during an 8-week period before baseline and those during an 8-week period before 12 month follow'}, {'measure': 'Improvement of depressive symptoms as measured with the Center for Epidemiologic Studies Depression Scale (CES-D)', 'timeFrame': '12 months', 'description': 'Mean difference between CES-D scores at baseline and at 12 month follow up'}, {'measure': 'Improvement of depressive symptoms as measured with the Patient Health Questionnaire Module for Depression (PHQ-9)', 'timeFrame': '12 months', 'description': 'Mean difference between PHQ-9 scores at baseline and at 12 month follow up'}, {'measure': 'IImprovement of diabetes distress as measured with the Problem Areas in Diabetes Scale (PAID)', 'timeFrame': '12 months', 'description': 'Mean difference between PAID scores at baseline and at 12 month follow'}, {'measure': 'IImprovement of diabetes distress as measured with the Diabetes Distress Scale (DDS)', 'timeFrame': '12 months', 'description': 'Mean difference between DDS scores at baseline and at 12 month follow'}, {'measure': 'Improvement of self-care behaviour as measured with the Summary of Diabetes Self-Care Activities Measure (SDSCA)', 'timeFrame': '12 months', 'description': 'Mean difference between SDSCA scores at baseline and at 12 month follow'}, {'measure': 'Improvement of self-care behaviour as measured with the Diabetes Self-Management Questionnaire (DSMQ)', 'timeFrame': '12 months', 'description': 'Mean difference between DSMQ scores at baseline and at 12 month follow'}, {'measure': 'Improvement of diabetes acceptance as measured with the Diabetes Acceptance Scale (DAS)', 'timeFrame': '12 months', 'description': 'Mean difference between DAS scores at baseline and at 12 month follow'}, {'measure': 'Improvement of quality of life as measured with the EuroQol Five-Dimensions Questionnaire (EQ-5D)', 'timeFrame': '12 months', 'description': 'Mean difference between EQ-5D scores at baseline and at 12 month follow'}, {'measure': 'Improvement of quality of life as measured with the Short Form-36 Health Survey (SF-36)', 'timeFrame': '12 months', 'description': 'Mean difference between SF-36 scores at baseline and at 12 month follow'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes mellitus', 'Affective disorders', 'Depressive symptoms', 'Diabetes distress', 'Hyperglycaemia', 'Dysglycaemia', 'Glycaemic control', 'Self-care behaviour', 'Quality of Life', 'Diabetes acceptance', 'Diabetes complications', 'Low-grade inflammation', 'Inflammatory markers', 'Stress reactivity', 'Health-care costs'], 'conditions': ['Diabetes Mellitus', 'Affective Disorders', 'Depression', 'Depressive Symptoms', 'Emotional Distress', 'Diabetes Complications']}, 'referencesModule': {'references': [{'pmid': '37498716', 'type': 'DERIVED', 'citation': 'Schmitt A, Ehrmann D, Kuniss N, Muller N, Kulzer B, Hermanns N. Assessing fear of complications in people with type 1 and type 2 diabetes with the Fear of Diabetes Complications Questionnaire. Health Psychol. 2023 Sep;42(9):674-685. doi: 10.1037/hea0001304. Epub 2023 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'This randomised controlled trial evaluates a cognitive-behavioural intervention for diabetes patients with suboptimal glycaemic control and comorbid depressive symptoms and/or diabetes distress. The main outcome is the improvement of suboptimal glycaemic control (HbA1c). Secondary outcomes are effects on depressive symptoms, diabetes distress, self-care behaviour, diabetes acceptance and quality of life. The treatment group will be treated with a cognitive-behavioural group treatment comprising specific interventions to improve glycaemic control and reduce diabetes distress as well as depressive symptoms. The control group will receive treatment-as-usual. A total of 212 study participants will be included. A secondary study objective is to analyse associations of suboptimal glycaemic control, depressive symptoms and diabetes distress with inflammatory markers.', 'detailedDescription': 'Suboptimal glycaemic control is an established risk factor for the development of serious long-term complications of diabetes. Moreover, it is associated with elevated risks of significant hyperglycaemic acute events such as hyperosmolar hyperglycemic state or diabetic ketoacidosis. Hence, patients with diabetes and persistent suboptimal glycaemic control are at higher risk of having a rather poor prognosis.\n\nBesides physiological and medical factors, psychological problems have been found to predict suboptimal glycaemic control. A number of studies found depressive symptoms to be independently associated with hyperglycaemia. Others focussed on diabetes-specific affective problems - the so called diabetes distress - and suggested this factor to be of great importance. Finally, some studies found that depressive symptoms and diabetes distress may interact, with the coocurrence of these factors being associated with the highest risk or suboptimal glycaemic control. The results correspond to other findings suggesting that both depressive symptoms and diabetes distress are often associated with reduced diabetes self-care, which can explain the associations of those factors with hyperglycaemia.\n\nOn the other hand, suboptimal glycaemic control could also be an explanation for affective problems - either mediated by physiological mechanisms or psychological ones, e.g. dissatisfaction or guilt. Hence, it is valid to assume that the link between depressive symptoms and/or diabetes distress may be bidirectional - although evidence to support this assumption is missing.\n\nFollowing this evidence and background, the investigators designed the a to analyse the relationships between suboptimal glycaemic control, depressive symptoms and diabetes distress in diabetes using a prospective study design. The study is a randomized trial in which a cognitive-behavioural group treatment is compared to a treatment-as-usual condition (standard diabetes education) regarding their efficacy in improving suboptimal glycaemic control. 212 diabetes patients with suboptimal glycaemic control (HbA1c value \\> 7.5%) and elevated depressive symptoms (Center for Epidemiologic Studies Depressions Scale score ≥ 16) and/or elevated diabetes distress (Problem Areas In Diabetes Scale score ≥ 40) will be randomly assigned to either the treatment group or treatment-as-usual. The primary outcome is the improvement of suboptimal glycaemic control (reduction of HbA1c) in the 12-month follow-up. As secondary outcomes positive baseline-to-follow up changes regarding depressive symptoms, diabetes distress, diabetes self-care behaviour, diabetes acceptance and quality of life are assessed.\n\nA second study objective is to analyse cross-sectional and prospective associations of suboptimal glycaemic control, depressive symptoms and diabetes distress with serum levels of the following inflammatory markers: hsCRP, IL-6, IL-18, IL-1Ra, MCP-1 and Adiponectin. Potential effects of the treatment groups on these markers will also be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 70\n* Diabetes mellitus type 1 or type 2\n* Diabetes duration ≥ 1 year\n* Suboptimal glycaemic control (HbA1c \\> 7,5%)\n* Elevated depressive symptoms (CES-D score ≥ 16) and/or elevated diabetes distress (PAID score ≥ 40)\n* Sufficient language skills\n* Written informed consent\n\nExclusion Criteria:\n\n* Severe major depressive disorder according to ICD-10\n* Current psychiatric and/or psychotherapeutic treatment\n* Current antidepressive medical treatment\n* Suicidal ideation\n* Acute mental disorder of the following type: schizophrenia or other psychotic disorder, bipolar disorder, severe eating disorder (anorexia nervosa, bulimia nervosa), substance use disorder\n* History of personality disorder\n* Severe somatic illnesses: dialysis-dependent nephropathy, acute cancer, severe heart disease (NYHA III - IV), severe neurologic illness (e. g. MS, dementia), severe autoimmune disease\n* Terminal illness\n* Bedriddenness\n* Guardianship'}, 'identificationModule': {'nctId': 'NCT02675257', 'acronym': 'DDCT', 'briefTitle': 'Depression and Diabetes Control Trial', 'organization': {'class': 'OTHER', 'fullName': 'Forschungsinstitut der Diabetes Akademie Mergentheim'}, 'officialTitle': 'Depression and Diabetes Control Trial', 'orgStudyIdInfo': {'id': 'FKZ 82DZD01101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive-behavioural group treatment', 'description': 'Five group sessions of diabetes-Specific cognitive-behavioural group treatment for diabetes patients with depressive symptoms and/or diabetes distress and suboptimal glycaemic control.\n\nInterventions:\n\n* Diabetes-related affective problems analysis\n* Goal setting towards improvement of glycaemic control\n* Diabetes-specific problem-solving therapy\n* Interventions to increase diabetes treatment motivation\n* Activation of personal and social resources\n* Reduction of barriers to self-care/glycaemic control\n* Cognitive restructuring of diabetes-related problems\n* Goal definition regarding self-care/glycaemia/well-being', 'interventionNames': ['Behavioral: Diabetes-related affective problems analysis', 'Behavioral: Goal setting towards improvement of glycaemic control', 'Behavioral: Diabetes-specific problem-solving therapy', 'Behavioral: Interventions to increase diabetes treatment motivation', 'Behavioral: Activation of personal and social resources', 'Behavioral: Reduction of barriers to self-care/glycaemic control', 'Behavioral: Cognitive restructuring of diabetes-related problems', 'Behavioral: Goal definition regarding self-care/glycaemia/well-being']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment-as-usual', 'description': 'Standard diabetes education.\n\nInterventions:\n\n* Health care and specific topics (e. g. blood pressure)\n* Healthy foods, cooking recommendations, recipes\n* Sports, activities and exercise\n* Foot care: exercises, care \\& control, injuries, neuropathy\n* Diabetes complications\n* Social aspects of living with diabetes', 'interventionNames': ['Behavioral: Health care and specific topics (e. g. blood pressure)', 'Behavioral: Healthy foods, cooking recommendations, recipes', 'Behavioral: Sports, activities and exercise', 'Behavioral: Foot care: exercises, care & control, injuries, neuropathy', 'Behavioral: Diabetes complications', 'Behavioral: Social aspects of living with diabetes']}], 'interventions': [{'name': 'Diabetes-related affective problems analysis', 'type': 'BEHAVIORAL', 'description': 'Analysis of diabetes-related affective problems with regard to suboptimal glycaemic control', 'armGroupLabels': ['Cognitive-behavioural group treatment']}, {'name': 'Goal setting towards improvement of glycaemic control', 'type': 'BEHAVIORAL', 'description': 'Discussing and setting goals regarding improvements of suboptimal glycaemic control, depressive symptoms and diabetes distress', 'armGroupLabels': ['Cognitive-behavioural group treatment']}, {'name': 'Diabetes-specific problem-solving therapy', 'type': 'BEHAVIORAL', 'description': 'Diabetes-specific problem-solving therapy with main focus on suboptimal glycaemic control, depressive symptoms and diabetes distress', 'armGroupLabels': ['Cognitive-behavioural group treatment']}, {'name': 'Interventions to increase diabetes treatment motivation', 'type': 'BEHAVIORAL', 'description': 'Interventions to increase diabetes treatment motivation in order to achieve improvements of glycaemic control as well as recovery from affective problems', 'armGroupLabels': ['Cognitive-behavioural group treatment']}, {'name': 'Activation of personal and social resources', 'type': 'BEHAVIORAL', 'description': 'Activation of personal and social resources with a view to diabetes control and affective problems', 'armGroupLabels': ['Cognitive-behavioural group treatment']}, {'name': 'Reduction of barriers to self-care/glycaemic control', 'type': 'BEHAVIORAL', 'description': 'Definition and reduction of barriers to adequate diabetes self-care behaviour as well as good glycaemic control', 'armGroupLabels': ['Cognitive-behavioural group treatment']}, {'name': 'Cognitive restructuring of diabetes-related problems', 'type': 'BEHAVIORAL', 'description': 'Cognitive restructuring of diabetes-related problems such as suboptimal glycaemic control and diabetes-related affective problems', 'armGroupLabels': ['Cognitive-behavioural group treatment']}, {'name': 'Goal definition regarding self-care/glycaemia/well-being', 'type': 'BEHAVIORAL', 'description': 'Goal definition and agreement regarding diabetes self-care behaviour, optimal glycaemic control and activities supporting well-being and recovery from affective symptoms', 'armGroupLabels': ['Cognitive-behavioural group treatment']}, {'name': 'Health care and specific topics (e. g. blood pressure)', 'type': 'BEHAVIORAL', 'description': 'Education on health care and specific topics (e. g. blood pressure)', 'armGroupLabels': ['Treatment-as-usual']}, {'name': 'Healthy foods, cooking recommendations, recipes', 'type': 'BEHAVIORAL', 'description': 'Education on healthy and unhealthy foods, cooking and recipes', 'armGroupLabels': ['Treatment-as-usual']}, {'name': 'Sports, activities and exercise', 'type': 'BEHAVIORAL', 'description': 'Education on sports, activities and exercise', 'armGroupLabels': ['Treatment-as-usual']}, {'name': 'Foot care: exercises, care & control, injuries, neuropathy', 'type': 'BEHAVIORAL', 'description': 'Education on foot care: exercises, care and control, injuries, and diabetic neuropathy', 'armGroupLabels': ['Treatment-as-usual']}, {'name': 'Diabetes complications', 'type': 'BEHAVIORAL', 'description': 'Education on diabetes complications', 'armGroupLabels': ['Treatment-as-usual']}, {'name': 'Social aspects of living with diabetes', 'type': 'BEHAVIORAL', 'description': 'Education on social aspects of living with diabetes', 'armGroupLabels': ['Treatment-as-usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97980', 'city': 'Bad Mergentheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Diabetes Center Mergentheim', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}, {'zip': '97980', 'city': 'Bad Mergentheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Forschungsinstitut der Diabetes Akademie Mergentheim e. V.', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}], 'overallOfficials': [{'name': 'Thomas Haak, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diabetes Center Mergentheim'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forschungsinstitut der Diabetes Akademie Mergentheim', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Center for Diabetes Research', 'class': 'OTHER'}, {'name': 'Helmholtz Zentrum München', 'class': 'INDUSTRY'}, {'name': 'German Diabetes Center', 'class': 'OTHER'}, {'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. phil. Norbert Hermanns', 'investigatorFullName': 'Norbert Hermanns', 'investigatorAffiliation': 'Forschungsinstitut der Diabetes Akademie Mergentheim'}}}}