Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-20 @ 10:45 PM
Study NCT ID:
NCT01012856
Status:
UNKNOWN
Last Update Posted:
2012-10-31
First Post:
2009-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Clinical Trial of an Exposure-based Cognitive Therapy for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 142}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-30', 'studyFirstSubmitDate': '2009-11-11', 'studyFirstSubmitQcDate': '2009-11-11', 'lastUpdatePostDateStruct': {'date': '2012-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severity of depressive symptoms measured by the Beck-Depression-Inventory (BDI-II)', 'timeFrame': 'end of therapy, 6 month after end of therapy (follow up)'}], 'secondaryOutcomes': [{'measure': 'symptom impairment measured by the Brief Symptom Inventory (BSI)', 'timeFrame': 'end of therapy, 6-month follow up'}, {'measure': 'quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF)', 'timeFrame': 'end of therapy, 6-month follow-up'}, {'measure': 'interpersonal problems measured by the Inventory of Interpersonal Problems (IIP)', 'timeFrame': 'end of therapy, 6-month follow-up'}, {'measure': 'avoidance measured by the Cognitive-Behavioral Avoidance Scales (CBAS)', 'timeFrame': 'end of therapy, 6-month follow-up'}, {'measure': 'resources measured by the Bernese Inventory of Resources (RES-K)', 'timeFrame': 'end of therapy, 6-month follow-up'}, {'measure': 'explicit self-esteem measured by the Rosenberg self-esteem scale (RSES)', 'timeFrame': 'end of therapy, 6-month follow up'}, {'measure': 'implicit self-esteem measured by the Self-Esteem Implicit Association Test (SE-IAT)', 'timeFrame': 'end of therapy'}, {'measure': 'goal attainment measured by Goal Attainment Scaling (GAS)', 'timeFrame': 'end of therapy'}, {'measure': 'avoidance motivation measured by the Inventory of Approach and Avoidance Motivation (IAAM)', 'timeFrame': 'end of therpy, 6-month follow-up'}, {'measure': 'motivational incongruence measured by The Incongruence Questionnaire (INC)', 'timeFrame': 'end of therapy, 6-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depressive episode', 'psychotherapy', 'cognitive therapy', 'emotional processing', 'RCT', 'exposure', 'dual process model', 'Implicit Association Test', 'mechanism of change'], 'conditions': ['Unipolar Depression']}, 'referencesModule': {'references': [{'pmid': '17563158', 'type': 'BACKGROUND', 'citation': 'Hayes AM, Feldman GC, Beevers CG, Laurenceau JP, Cardaciotto L, Lewis-Smith J. Discontinuities and cognitive changes in an exposure-based cognitive therapy for depression. J Consult Clin Psychol. 2007 Jun;75(3):409-421. doi: 10.1037/0022-006X.75.3.409.'}, {'pmid': '9874907', 'type': 'BACKGROUND', 'citation': 'Hayes AM, Strauss JL. Dynamic systems theory as a paradigm for the study of change in psychotherapy: an application to cognitive therapy for depression. J Consult Clin Psychol. 1998 Dec;66(6):939-47. doi: 10.1037//0022-006x.66.6.939.'}, {'pmid': '17316941', 'type': 'BACKGROUND', 'citation': 'Hayes AM, Laurenceau JP, Feldman G, Strauss JL, Cardaciotto L. Change is not always linear: the study of nonlinear and discontinuous patterns of change in psychotherapy. Clin Psychol Rev. 2007 Jul;27(6):715-23. doi: 10.1016/j.cpr.2007.01.008. Epub 2007 Jan 19.'}, {'pmid': '15905008', 'type': 'BACKGROUND', 'citation': 'Beevers CG. Cognitive vulnerability to depression: a dual process model. Clin Psychol Rev. 2005 Nov;25(7):975-1002. doi: 10.1016/j.cpr.2005.03.003.'}, {'pmid': '19170458', 'type': 'BACKGROUND', 'citation': 'Pascual-Leone A. Dynamic emotional processing in experiential therapy: two steps forward, one step back. J Consult Clin Psychol. 2009 Feb;77(1):113-26. doi: 10.1037/a0014488.'}, {'pmid': '38010758', 'type': 'DERIVED', 'citation': 'Babl A, Rubel J, Gomez Penedo JM, Berger T, Grosse Holtforth M, Eubanks CF. Can session-by-session changes in self-reported alliance scores serve as a measure of ruptures in the therapeutic alliance? J Consult Clin Psychol. 2024 Feb;92(2):129-133. doi: 10.1037/ccp0000861. Epub 2023 Nov 27.'}, {'pmid': '29130400', 'type': 'DERIVED', 'citation': 'Grosse Holtforth M, Krieger T, Zimmermann J, Altenstein-Yamanaka D, Dorig N, Meisch L, Hayes AM. A randomized-controlled trial of cognitive-behavioral therapy for depression with integrated techniques from emotion-focused and exposure therapies. Psychother Res. 2019 Jan;29(1):30-44. doi: 10.1080/10503307.2017.1397796. Epub 2017 Nov 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate, if exposure-based cognitive therapy (EBCT) is at least as effective as the established cognitive-behavioral therapy and more effective in its long-term efficacy. Moreover the mechanisms of change of the EBCT are investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major Depressive Disorder according to DSM-IV as main diagnosis\n* minimum standardized depression scores (BDI \\>= 17; HAMD \\>=13)\n* minimum age of 18 years\n* informed consent to participate voluntarily in the study\n* sufficient German language skills\n\nExclusion Criteria:\n\n* acute suicidality\n* depressive disorder with mood-incongruent psychotic features\n* chronic depressive disorder\n* organic cause of depression\n* drug-induced depression\n* bipolar disorder\n* diagnosis of schizophrenia, schizophreniform, schizoaffective disorders, and/or psychosis NOS\n* comorbid dysthymia, psychotic disorder (acute or anamnestic), dementia, substance dependence, schizotypal/ borderline/ or antisocial personality disorder\n* psychopharmacological treatment other than antidepressants\n* antidepressant medication, if it is changed within one month prior to the beginning of psychotherapy\n* other simultaneous psychological treatments'}, 'identificationModule': {'nctId': 'NCT01012856', 'briefTitle': 'Randomized Clinical Trial of an Exposure-based Cognitive Therapy for Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Explicit and Implicit Change of Depression in Exposure-based Cognitive Therapy', 'orgStudyIdInfo': {'id': 'PP00P1_ 123377'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive-Behavioral Therapy for Depression (CBT)', 'interventionNames': ['Behavioral: Cognitive-Behavioral Therapy for Depression']}, {'type': 'EXPERIMENTAL', 'label': 'Exposure-Based Cognitive Therapy for Depression (EBCT)', 'interventionNames': ['Behavioral: Exposure-Based Cognitive Therapy for Depression']}], 'interventions': [{'name': 'Cognitive-Behavioral Therapy for Depression', 'type': 'BEHAVIORAL', 'description': '22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on cognitive restructuring without emotion-focused interventions', 'armGroupLabels': ['Cognitive-Behavioral Therapy for Depression (CBT)']}, {'name': 'Exposure-Based Cognitive Therapy for Depression', 'type': 'BEHAVIORAL', 'description': '22 weekly sessions and 2 booster session of face to face outpatient psychotherapy; focus on emotion-focused interventions', 'armGroupLabels': ['Exposure-Based Cognitive Therapy for Depression (EBCT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8050', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University of Zurich, Department of Psychology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Martin Grosse Holtforth, Professor MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich, Department of Psychology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}