Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT01566318
Status:
COMPLETED
Last Update Posted:
2016-12-13
First Post:
2012-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Depression Agency-Based Collaboration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-11', 'studyFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2012-03-28', 'lastUpdatePostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major depressive disorder', 'timeFrame': '12 months', 'description': 'Patient Health Questionnaire score \\> 9 with confirming diagnostic interview'}, {'measure': 'Generalized anxiety disorder', 'timeFrame': '12 months', 'description': 'Generalized anxiety disorder score \\>=10, and meets criteria for SCID or PRIME-MD diagnosis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Depression', 'Anxiety', 'Geriatric mental health'], 'conditions': ['Major Depression', 'Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '19255379', 'type': 'BACKGROUND', 'citation': "van't Veer-Tazelaar PJ, van Marwijk HW, van Oppen P, van Hout HP, van der Horst HE, Cuijpers P, Smit F, Beekman AT. Stepped-care prevention of anxiety and depression in late life: a randomized controlled trial. Arch Gen Psychiatry. 2009 Mar;66(3):297-304. doi: 10.1001/archgenpsychiatry.2008.555."}]}, 'descriptionModule': {'briefSummary': 'Seniors who receive supportive services face a variety of psychosocial vulnerabilities that put them at risk for depression. One group with very high risk is older adults receiving aging services through Medicaid waiver programs. This 3-year research uses a randomized controlled clinical trial to assess the effectiveness of brief behavioral therapies (problem solving therapy \\[PST\\] and Brief Behavioral Therapy for Insomnia \\[BBTI\\]) to prevent depression in seniors receiving aging services.', 'detailedDescription': 'The research will determine (i) if a course of problem solving therapy (PST) and Brief Behavioral Therapy for Insomnia (BBTI), with boosters, reduces incidence of major depressive episodes over 12 months relative to usual care, and (ii) the extent to which behavioral therapies achieve these effects through enhancement of protective factors, such as greater self-efficacy, better targeting of services to address needs, and greater control over home environments.\n\nPeriodic blood draws will be used to assess biosignatures of depression. Guiding our investigations of pharmacogenetics, inflammation, and proteomics are synergistic interactions among the serotonergic system, the HPA axis, systemic inflammation, growth factors such as brain derived neuro-trophic factor (BDNF), psychosocial stressors, and vascular co-morbidity. Genetic variation in vasopressin receptors, potentially involved in both cardiovascular risk and social attachment, is also associated with recurrence of depression. Similarly, genetic variation in inflammation may influence antidepressant response and medical co-morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age =\\> 60 years\n* Modified Mini Mental State (3MS) Examination =\\>80\n* Receiving aging services or difficulty with 1+ ADL/IADL\n* PHQ-9 score \\> 0 and \\<= 9 (and question 1 or 2 is \\>0)\n\nExclusion Criteria:\n\n* Major depressive episode or anxiety disorder within 12 mo\n* Ever diagnosed with bipolar disorder or schizophrenia\n* Drug or alcohol use disorder within the past 12 months\n* Currently taking antidepressants\n* Currently taking antianxiety med \\>4x/week for past 4 weeks'}, 'identificationModule': {'nctId': 'NCT01566318', 'briefTitle': 'Depression Agency-Based Collaboration', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Depression Agency-Based Collaborative (Depression ABC)', 'orgStudyIdInfo': {'id': 'P30MH090333-PRC1'}, 'secondaryIdInfos': [{'id': 'P30MH090333', 'link': 'https://reporter.nih.gov/quickSearch/P30MH090333', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Problem solving therapy (PST)', 'description': '6-8 sessions of PST, with booster, delivered over 8 weeks', 'interventionNames': ['Behavioral: Problem-Solving Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual agency care, monitored for mental health services'}], 'interventions': [{'name': 'Problem-Solving Therapy', 'type': 'BEHAVIORAL', 'description': '6-8 sessions over 8 weeks, with booster', 'armGroupLabels': ['Problem solving therapy (PST)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Steven M Albert, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Steven M. Albert', 'investigatorAffiliation': 'University of Pittsburgh'}}}}