Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2026-02-17 @ 6:51 PM
Study NCT ID:
NCT01402206
Status:
COMPLETED
Last Update Posted:
2016-08-16
First Post:
2011-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Depression in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-15', 'studyFirstSubmitDate': '2011-06-27', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Depressive symptoms', 'timeFrame': '3, 6 and 12 months.', 'description': 'Depressive symptoms will be assessed using the Beck Depression Inventory (BDI-II), a self-administered questionnaire that measures the symptoms and severity of the depression.'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of life', 'timeFrame': '3, 6 and 12 months', 'description': "Each patient's quality of life will be assessed using the EuroQoL-5D questionnaire that measures five dimensions of quality of life"}, {'measure': 'Prescriptions for antidepressants', 'timeFrame': '12-month follow-up period', 'description': 'Information on Antidepressant use will be collected from patient records from start of the study and the 12-month follow-up period'}, {'measure': 'Change in Activity/work ability', 'timeFrame': '12-month follow-up period', 'description': "Will be measured by Work Ability Index (WAI) and the Karaseks Job Strain Model Questionnaire. The Work Ability Index is used for evaluating people's work capacity and Karaseks Job Strain Model Questionnaire is used for evaluating Demands-Control in work place"}, {'measure': 'sick-listing data', 'timeFrame': '12 month follow up', 'description': 'Data on sick-listing is derived from primary care record fom baseline to 3 months follow up and from patient interview from 3 to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Intervention', 'Primary health care'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '28103816', 'type': 'DERIVED', 'citation': 'Wikberg C, Westman J, Petersson EL, Larsson ME, Andre M, Eggertsen R, Thorn J, Agren H, Bjorkelund C. Use of a self-rating scale to monitor depression severity in recurrent GP consultations in primary care - does it really make a difference? A randomised controlled study. BMC Fam Pract. 2017 Jan 19;18(1):6. doi: 10.1186/s12875-016-0578-9.'}]}, 'descriptionModule': {'briefSummary': 'Most people in Sweden with mild to moderate depression are treated in primary care, but follow-up is unstructured, and we know little about whether structured, follow-up would affect the prognosis for depression and working life. The purpose of this study is to determine the effectiveness of regular, structured, patient-centered visits on mild to moderate depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Age 18 years and up\n* Attends a participating primary health care center in the region\n* Diagnosis of mild/moderate depressive disorder (new episode)\n* No change in possible antidepressant maintenance therapy during the preceding 1 month\n* Provided written informed consent\n\nExclusion criteria\n\n* Antidepressant medication initiated or changed during the preceding 1 month\n* Patient diagnosed with major depressive disorder (BDI-II \\>28)\n* Patients diagnosed of severe mental psychiatric disorder (i.e. bipolar disorder, antisocial personality disorder, psychosis, substance use disorder or other serious mental disorder)\n* Suicidal ideation or intentions\n* Inability to speak and understand Swedish language well enough to take part in the activities required in the study.\n* Cognitive impairment that makes it impossible to take part in the activities required in the study\n* Does not provide written informed consent to participation in the study'}, 'identificationModule': {'nctId': 'NCT01402206', 'briefTitle': 'Management of Depression in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Göteborg University'}, 'officialTitle': 'Management of Depression in Primary Health Care: a Controlled Trial on the Effectiveness of Regular, Structured, Patient-centered Visits', 'orgStudyIdInfo': {'id': 'Madrs 2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Structured patient visits', 'description': 'Participants in the intervention group visit their general practitioner at baseline and 4, 8, and 12 weeks. At each visit, participants complete MADRS-s for the assessment of depression severity and discuss the results with their GP in a patient-centered consultation.', 'interventionNames': ['Behavioral: Structured patient-centered follow up of depression']}, {'type': 'OTHER', 'label': 'Treatment as usual', 'description': 'The control group receives treatment as usual by general practitioner (no intervention).', 'interventionNames': ['Behavioral: Structured patient-centered follow up of depression']}], 'interventions': [{'name': 'Structured patient-centered follow up of depression', 'type': 'BEHAVIORAL', 'otherNames': ['MADRS/MADRS-S depression rating scale'], 'description': 'All patients who agree to participate in the study are diagnosed by their GP with a diagnostic assessment instrument called PRIME-MD. Participants in the intervention group visit their GPs at baseline and 4, 8, and 12 weeks. At each visit, participants complete MADRS-s for the assessment of depression severity and discuss the results with their GP in a patient-centered consultation. We have chosen to use the MADRS/MADRS-S depression rating scale in this study because it is a easy to use standard instrument especially suitable for measuring change in depressive symptoms.\n\nThe control group receives treatment as usual (no intervention).', 'armGroupLabels': ['Structured patient visits', 'Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'University of Gothenburg', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Cecila Björkelund, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Göteborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}