Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-02-25 @ 11:47 PM
Study NCT ID:
NCT02883257
Status:
COMPLETED
Last Update Posted:
2018-04-23
First Post:
2016-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Biological Markers of Response to Cognitive Behavioural Therapy for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2016-08-19', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery Asberg Depression Rating Scale', 'timeFrame': '16 weeks', 'description': 'Depression symptom severity'}], 'secondaryOutcomes': [{'measure': 'Quick Inventory of Depressive Symptomatology (QIDS)', 'timeFrame': '16 weeks', 'description': 'Depression symptom severity'}, {'measure': 'World Health Organization Quality of Life Short Version (WHOQOL-BREF)', 'timeFrame': '16 weeks', 'description': 'Quality of life'}, {'measure': 'Hamilton Depression Rating Scale (Ham-D)', 'timeFrame': '16 weeks', 'description': 'Depression symptom severity'}, {'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': '16 weeks', 'description': 'Depression symptom severity'}, {'measure': 'Work and Social Adjustment Scale (WSAS)', 'timeFrame': '16 weeks', 'description': 'Functioning and impairment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major Depression', 'Major Depressive Disorder', 'Persistent Depressive Disorder', 'Cognitive Behavioral Therapy', 'Biomarkers'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '34419752', 'type': 'DERIVED', 'citation': 'Jones BDM, Levitan RD, Wang W, Uher R, Rotzinger S, Foster JA, Kennedy SH, Farzan F, Quilty LC, Kloiber S. Metabolic variables associated with response to cognitive behavioural therapy for depression in females: A Canadian biomarker integration network for depression (CAN-BIND) study. J Psychiatr Res. 2021 Oct;142:321-327. doi: 10.1016/j.jpsychires.2021.07.031. Epub 2021 Jul 21.'}], 'seeAlsoLinks': [{'url': 'http://www.camh.ca/research', 'label': 'Information about research at the Centre for Addiction and Mental Health'}, {'url': 'http://www.canbind.ca', 'label': 'Information about research by the Canadian Biomarker Integration Network in Depression'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to locate clinical markers (for example, interviews, questionnaires, and computer tasks) and biological markers (for example, physiological, blood-based, or electroencephalography measurements) that predict response to cognitive behavioral therapy for depression.', 'detailedDescription': 'Forty adult outpatients with major depressive disorder or persistent depressive disorder will receive up to 20 sessions of cognitive behavioral therapy for depression over 16 weeks. Participants will complete clinical measures (interviews, questionnaires, and computer-based tasks) and biological measures (blood tests, physiological measurements, electroencephalography ) before, during, and after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Major Depressive Disorder or Persistent Depressive Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition\n* Must be fluent in English\n* Must be capable to give informed consent\n\nExclusion Criteria:\n\n* Lifetime diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar Disorder\n* Current Alcohol or Drug Use Disorder (except tobacco or caffeine)\n* Current psychotic symptoms\n* Acute suicide risk\n* Psychological treatment for depression initiated during the past three months\n* Pharmacological treatment for depression initiated/changed during the past three months\n* Previous non-response to two or more adequate trials of pharmacotherapy\n* Current significant neurological disorder, head trauma, or unstable medical conditions.'}, 'identificationModule': {'nctId': 'NCT02883257', 'briefTitle': 'Clinical and Biological Markers of Response to Cognitive Behavioural Therapy for Depression', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'Clinical and Biological Markers of Response to Cognitive Behavioural Therapy for Depression', 'orgStudyIdInfo': {'id': '003/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Therapy', 'description': '* 20 individual 60-minute appointments over the course of 16 weeks\n* Consistent with Beck, Rush, Shaw, and Emery (1979)', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy']}], 'interventions': [{'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'Cognitive Behavioral Therapy will include core mandatory modules of key effective components (e.g., behavioural activation, cognitive restructuring) and optional elements to address individual maintaining factors (e.g., coping and social skills training, perfectionism and self-criticism).', 'armGroupLabels': ['Cognitive Behavioral Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 1R8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Lena C Quilty, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Health Network, Toronto', 'class': 'OTHER'}, {'name': 'Dalhousie University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Independent Scientist', 'investigatorFullName': 'Lena Quilty', 'investigatorAffiliation': 'Centre for Addiction and Mental Health'}}}}