Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 5:55 AM
Study NCT ID:
NCT01139060
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2010-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Organized Self-Management Support Services for Chronic Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2010-06-04', 'studyFirstSubmitQcDate': '2010-06-07', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Evaluate the program's effectiveness, i.e., the effects of the intervention on patient outcomes (depressive symptoms, functional impairment, and disability/lost productivity) and process of care (self-efficacy and self-management behaviors)", 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Examination of moderators of treatment response', 'timeFrame': '18 months'}, {'measure': "An estimate of the program's costs and effect on the costs of treatment for depression", 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic or recurrent depression'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '28726086', 'type': 'DERIVED', 'citation': 'Jones SMW, Ludman EJ. Factor Structure and Sensitivity to Change of the Recovery Assessment Scale. J Behav Health Serv Res. 2018 Oct;45(4):690-699. doi: 10.1007/s11414-017-9563-x.'}, {'pmid': '26278222', 'type': 'DERIVED', 'citation': 'Ludman EJ, Simon GE, Grothaus LC, Richards JE, Whiteside U, Stewart C. Organized Self-Management Support Services for Chronic Depressive Symptoms: A Randomized Controlled Trial. Psychiatr Serv. 2016 Jan;67(1):29-36. doi: 10.1176/appi.ps.201400295. Epub 2015 Aug 17.'}]}, 'descriptionModule': {'briefSummary': "The purpose is to test the effectiveness of an organized care program for chronic or recurrent depression. Using a two-arm design, the investigators will randomly assign 300 participants with chronic or recurrent depression to one of two conditions: continued usual care (UC); or an 18-month organized treatment program focused on outreach and engagement, including a weekly group self-management training program, monthly visits with a psychotherapist (in-person or by telephone), and optional one-on-one visits with a peer support specialist. All intervention components are intended as adjuncts to any existing depression treatment (usually antidepressant medication) provided by participants' regular providers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients will meet criteria for recurrent major depression or dysthymia\n\nExclusion Criteria:\n\n* bipolar disorder or psychotic disorder'}, 'identificationModule': {'nctId': 'NCT01139060', 'acronym': 'Stride', 'briefTitle': 'Organized Self-Management Support Services for Chronic Depression', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Organized Self-Management Support Services for Chronic Depression', 'orgStudyIdInfo': {'id': '5R01MH082995', 'link': 'https://reporter.nih.gov/quickSearch/5R01MH082995', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': '18-month organized treatment program focused on outreach and engagement for chronic or recurrent depression', 'interventionNames': ['Behavioral: organized care program for chronic or recurrent depression']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care'}], 'interventions': [{'name': 'organized care program for chronic or recurrent depression', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Group Health Research Insitute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cherry Hill Clinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Evette Ludman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Group Health Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}