Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-31 @ 6:43 AM
Study NCT ID:
NCT01542957
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2012-02-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D019263', 'term': 'Dysthymic Disorder'}, {'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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gfeixas@ub.edu', 'phone': '0034 933125100', 'title': 'Prof. Guillem Feixas', 'organization': 'Universitat de Barcelona'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': '"0" means that serious and other \\[non-serious\\] adverse events were not collected or assessed as part of the study since no detrimental effects were expected as result of psychotherapies.', 'eventGroups': [{'id': 'EG000', 'title': 'Cognitive Behavioral + Dilemma Therapy', 'description': 'Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention\n\nCombined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Combined Group and Individual Cognitive Behavioral Therapy\n\nCognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral + Dilemma Therapy', 'description': 'Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention\n\nCombined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.'}, {'id': 'OG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Combined Group and Individual Cognitive Behavioral Therapy\n\nCognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.23', 'spread': '8.96', 'groupId': 'OG000'}, {'value': '36.94', 'spread': '9.56', 'groupId': 'OG001'}]}]}, {'title': 'At the end of therapy change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.62', 'spread': '12.05', 'groupId': 'OG000'}, {'value': '-15.52', 'spread': '13.92', 'groupId': 'OG001'}]}]}, {'title': '3-month follow-up change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15.42', 'spread': '13.16', 'groupId': 'OG000'}, {'value': '-15.60', 'spread': '15.56', 'groupId': 'OG001'}]}]}, {'title': '12-month follow-up change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.51', 'spread': '13.17', 'groupId': 'OG000'}, {'value': '-16.65', 'spread': '13.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.96', 'ciLowerLimit': '-3.35', 'ciUpperLimit': '1.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'End of therapy (16 weeks), 3 and 12-month follow-up', 'description': 'To assess change in severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 63, with higher scores indicating more severity of depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hamilton-Depression Rating Scale-17 Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral + Dilemma Therapy', 'description': 'Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention\n\nCombined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.'}, {'id': 'OG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Combined Group and Individual Cognitive Behavioral Therapy\n\nCognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.93', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '20.05', 'spread': '6.09', 'groupId': 'OG001'}]}]}, {'title': 'At the end of therapy change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.61', 'spread': '9.21', 'groupId': 'OG000'}, {'value': '-8.84', 'spread': '8.28', 'groupId': 'OG001'}]}]}, {'title': '12 month follow-up change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.32', 'spread': '9.56', 'groupId': 'OG000'}, {'value': '-7.89', 'spread': '9.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '3.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '.53', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'End of therapy and 12-month follow-up', 'description': 'This clinician-administered measure was only applied to 78 patients at pre- and posttreatment. It measures severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 54, with higher scores indicating more severity of depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cognitive Behavioral + Dilemma Therapy', 'description': 'Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention\n\nCombined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.'}, {'id': 'OG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Combined Group and Individual Cognitive Behavioral Therapy\n\nCognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.17', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'At the end of therapy change from baselina', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-0.67', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': '3 month follow-up change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': '12 month follow-up change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '0.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'End of therapy, 3 and 12 month follow-up', 'description': 'To assess subjective well-being, symptoms or problems, life functioning, and risk. The Total score is reported, which is the sum of the ratings of all items divided by the number of items (34). The score and ranges from 0 to 4, with higher scores indicating more severity of psychological distress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed are those who completed the treatment but not all of them completed follow-up assessments at 3 and 12-month after the end of the therapy. In each row the number of those participants who completed the assessment are specified'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cognitive Behavioral + Dilemma Therapy', 'description': 'Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention\n\nCombined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.'}, {'id': 'FG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Combined Group and Individual Cognitive Behavioral Therapy\n\nCognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.'}], 'periods': [{'title': 'End of Therapy', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}, {'title': '3-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}, {'title': '12-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cognitive Behavioral + Dilemma Therapy', 'description': 'Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention\n\nCombined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.'}, {'id': 'BG001', 'title': 'Cognitive Behavioral Therapy', 'description': 'Combined Group and Individual Cognitive Behavioral Therapy\n\nCognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.37', 'spread': '11.22', 'groupId': 'BG000'}, {'value': '50.06', 'spread': '11.03', 'groupId': 'BG001'}, {'value': '49.20', 'spread': '11.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-17', 'studyFirstSubmitDate': '2012-02-26', 'resultsFirstSubmitDate': '2016-10-25', 'studyFirstSubmitQcDate': '2012-03-01', 'lastUpdatePostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-25', 'studyFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Beck Depression Inventory-Second Edition (BDI-II) at the End of Therapy, 3 and 12-month Follow-up', 'timeFrame': 'End of therapy (16 weeks), 3 and 12-month follow-up', 'description': 'To assess change in severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 63, with higher scores indicating more severity of depressive symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Hamilton-Depression Rating Scale-17 Items', 'timeFrame': 'End of therapy and 12-month follow-up', 'description': 'This clinician-administered measure was only applied to 78 patients at pre- and posttreatment. It measures severity of depressive symptoms. The Total score is reported, which is the sum of the ratings of all items and ranges from 0 to 54, with higher scores indicating more severity of depressive symptoms.'}, {'measure': 'Change From Baseline in Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) at the End of Therapy, 3 and12 Month Follow-up', 'timeFrame': 'End of therapy, 3 and 12 month follow-up', 'description': 'To assess subjective well-being, symptoms or problems, life functioning, and risk. The Total score is reported, which is the sum of the ratings of all items divided by the number of items (34). The score and ranges from 0 to 4, with higher scores indicating more severity of psychological distress.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Major Depressive Disorder', 'Dysthymic Disorder', 'Depression', 'Cognitive Behavior Therapy', 'Personal Construct Theory', 'Repertory Grid Technique', 'Cognitive Conflicts', 'Personal dilemmas'], 'conditions': ['Major Depressive Disorder', 'Dysthymic Disorder']}, 'referencesModule': {'references': [{'pmid': '23683841', 'type': 'BACKGROUND', 'citation': 'Feixas G, Bados A, Garcia-Grau E, Montesano A, Dada G, Compan V, Aguilera M, Salla M, Soldevilla JM, Trujillo A, Paz C, Botella L, Corbella S, Saul-Gutierrez LA, Canete J, Gasol M, Ibarra M, Medeiros-Ferreira L, Soriano J, Ribeiro E, Caspar F, Winter D. Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial. Trials. 2013 May 17;14:144. doi: 10.1186/1745-6215-14-144.'}, {'pmid': '27103215', 'type': 'RESULT', 'citation': 'Feixas G, Bados A, Garcia-Grau E, Paz C, Montesano A, Compan V, Salla M, Aguilera M, Trujillo A, Canete J, Medeiros-Ferreira L, Soriano J, Ibarra M, Medina JC, Ortiz E, Lana F. A DILEMMA-FOCUSED INTERVENTION FOR DEPRESSION: A MULTICENTER, RANDOMIZED CONTROLLED TRIAL WITH A 3-MONTH FOLLOW-UP. Depress Anxiety. 2016 Sep;33(9):862-9. doi: 10.1002/da.22510. Epub 2016 Apr 22.'}, {'pmid': '30543642', 'type': 'DERIVED', 'citation': 'Feixas G, Paz C, Garcia-Grau E, Montesano A, Medina JC, Bados A, Trujillo A, Ortiz E, Compan V, Salla M, Aguilera M, Guasch V, Codina J, Winter DA. One-year follow-up of a randomized trial with a dilemma-focused intervention for depression: Exploring an alternative to problem-oriented strategies. PLoS One. 2018 Dec 13;13(12):e0208245. doi: 10.1371/journal.pone.0208245. eCollection 2018.'}], 'seeAlsoLinks': [{'url': 'http://www.ub.edu/terdep', 'label': 'Web page in Spanish and Catalan describing the research project and recruitment information'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of a brief psychological intervention focused on the personal dilemmas identified for each depressive patient. For that, this intervention is combined to group cognitive therapy (an already proven efficacious format) and compared to cognitive individual therapy.', 'detailedDescription': 'Depression is one of the more severe and serious health problems because of its morbidity, disabling effects and for its societal and economic burden. Despite the variety of existing pharmacological and psychological treatments most of the cases evolve with only partial remission, relapse and recurrence.\n\nCognitive models made a significant contribution in the understanding of unipolar depression and its psychological treatment. Even though, success is only partial and many authors affirm the need to improve those models and also the treatment programs derived from them. One of the issues that requires further elaboration is the difficulty these patients experience in responding to treatment and in maintaining therapeutic gains across time without relapse or recurrence.\n\nOur research group has been working in the notion of cognitive conflict viewed as personal dilemma according to personal construct theory. The investigators use a novel method for identifying those conflicts using the repertory grid technique. Preliminary results with depressive patients show that more than 90% of them have one or more of those conflicts. This fact might explain the blockage and the difficult progress of these patients, especially the more severe and/or chronic. These results justify the need for specific interventions focused in the resolution of these internal conflicts.\n\nThis study aims to empirically test the hypothesis that an intervention focused on the dilemma(s) specifically detected for each patient will contribute to enhance the efficacy of Cognitive-Behavioral Therapy for depression. A therapy manual for this approach will be tested using a randomized clinical trial by comparing the outcome of two treatment conditions: a CBT treatment package and another package combining cognitive-behavioral and dilemma-focused interventions. The investigators expect that this combined package will increase the efficacy of CBT, one of the more prestigious therapies for depression, this resulting in a significant contribution for its treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meeting diagnostic criteria for Major Depressive Disorder (MDD) or Dysthymic Disorder (DD) according to the DSM-IV-TR (APA, 2002) criteria a assessed using SCID-I\n* A score above 19 on the BDI-II Questionnaire\n* Presenting at leat one cognitive conflict (implicative dilemma or dilemmatic construct) as assessed using the Repertory Grid Technique\n* Enough level of competence to communicate in Spanish or Catalan\n\nExclusion Criteria:\n\n* Bipolar disorders\n* Psychotic symptoms\n* Substance abuse\n* Organic brain dysfunction\n* Mental retardation\n* Serious suicidal ideation\n* Receiving psychological treatment (unless it is suspended at the time of inclusion in the study itself, in agreement with the patient and the practitioner applying it)\n* Substantial visual, hearing or cognitive deficits'}, 'identificationModule': {'nctId': 'NCT01542957', 'briefTitle': 'Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Barcelona'}, 'officialTitle': 'Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention', 'orgStudyIdInfo': {'id': 'dilemma2012'}, 'secondaryIdInfos': [{'id': 'PSI2011-23246', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Science and Innovation (Spanish Government)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral + Dilemma Therapy', 'description': 'Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention', 'interventionNames': ['Behavioral: Combined Cognitive Behavioral and Dilemma-Focused Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cognitive Behavioral Therapy', 'description': 'Combined Group and Individual Cognitive Behavioral Therapy', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy for Depression']}], 'interventions': [{'name': 'Combined Cognitive Behavioral and Dilemma-Focused Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Personal Construct Therapy'], 'description': '7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.', 'armGroupLabels': ['Cognitive Behavioral + Dilemma Therapy']}, {'name': 'Cognitive Behavioral Therapy for Depression', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Therapy'], 'description': 'Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.', 'armGroupLabels': ['Cognitive Behavioral Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08304', 'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Mataro (Consorci Sanitari del Maresme)', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'zip': '08004', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'CAP Les Hortes', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08004', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Fundació Sanitària Sant Pere Claver', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08032', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Associació Catalana de Teràpies Cognitives', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Guillem Feixas, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Barcelona', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Distance Education University (UNED)', 'class': 'UNKNOWN'}, {'name': 'University of Minho', 'class': 'OTHER'}, {'name': 'University of Hertfordshire', 'class': 'OTHER'}, {'name': 'University of Bern', 'class': 'OTHER'}, {'name': 'University Ramon Llull', 'class': 'OTHER'}, {'name': 'Institut Trastorn Límit', 'class': 'UNKNOWN'}, {'name': 'Hospital de Mataró', 'class': 'OTHER'}, {'name': 'Fundació Institut de Recerca de l', 'class': 'UNKNOWN'}, {'name': 'Associació Centre de Salut Mental Nou Barris', 'class': 'UNKNOWN'}, {'name': 'Fundacion IMIM', 'class': 'OTHER'}, {'name': 'EAP Poble Sec', 'class': 'UNKNOWN'}, {'name': 'Associació Catalana de Terapies Cognitives', 'class': 'UNKNOWN'}, {'name': 'Sant Pere Claver Fundació Sanitaria', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Guillem Feixas', 'investigatorAffiliation': 'University of Barcelona'}}}}