Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT02437357
Status:
COMPLETED
Last Update Posted:
2016-09-27
First Post:
2015-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial on Metacognitive Training for Depression (D-MCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-26', 'studyFirstSubmitDate': '2015-03-23', 'studyFirstSubmitQcDate': '2015-05-04', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hamilton Depression Rating Scale (HDRS), total score from pre to post treatment (4 weeks) and follow-up (3months)', 'timeFrame': '4 months', 'description': 'Clinician-rated severity of depressive symptoms, 17-item version, most commonly used interview-based measure of depression'}], 'secondaryOutcomes': [{'measure': 'Change in Beck Depression Inventory (BDI), total score from pre to post treatment (4 weeks) and follow-up (3months)', 'timeFrame': '4 months', 'description': 'Self-assessed severity of depressive symptoms (questionnaire)'}, {'measure': 'Change in Dysfunctional Attitudes Scale (DAS) from pre to post treatment (4 weeks) and follow-up (3months)', 'timeFrame': '4 months', 'description': 'questionnaire'}, {'measure': 'Change in Metacognitions Questionnaire (MCQ-30) from pre to post treatment (4 weeks) and follow-up (3months)', 'timeFrame': '4 months', 'description': 'questionnaire'}, {'measure': 'Change in Ruminative Responses Scale (RRS) from pre to post treatment (4 weeks) and follow-up (3months)', 'timeFrame': '4 months', 'description': 'questionnaire'}, {'measure': 'Change in Rosenberg Self-Esteem-Scale (RSE) from pre to post treatment (4 weeks) and follow-up (3months)', 'timeFrame': '4 months', 'description': 'questionnaire'}, {'measure': 'Change in quality of life (WHOQOL-BREF) from pre to post treatment (4 weeks) and follow-up (3months)', 'timeFrame': '4 months', 'description': 'questionnaire'}, {'measure': 'Change in coping (Brief-Cope) from pre to post treatment (4 weeks) and follow-up (3months)', 'timeFrame': '4 months', 'description': 'questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psychotherapy, Group', 'Metacognition', 'Cognitive Bias'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Jelinek L, Otte C, Arlt, S, Hauschildt M. Denkverzerrungen erkennen und korrigieren: Eine Machbarkeitsstudie zum Metakognitiven Training bei Depressionen (D-MKT). Zeitschrift für Psychiatrie und Psychotherapie, 61(4): 1-8, 2014.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the present randomized-controlled trial is to investigate the efficacy of Metacognitive Training for Depression (D-MCT), a new low-threshold, modular group intervention.', 'detailedDescription': 'Despite the existence of evidence-based treatment methods, a significant treatment gap remains for major depression. While in acute psychiatric treatment of severely depressed patients a pharmacological treatment is usually applied, depression-specific psychotherapeutic (group) concepts are rarely part of the treatment, though recommended in clinical guidelines. A main reason is that present group concepts were designed primarily for outpatient settings and do not meet the structural requirements of inpatient care (i.e., short residence time, continuous admissions and dismissals).\n\nMetacognitive Training for Depression (D-MCT) is a new low-threshold, modular group intervention which was designed to fill this treatment gap by addressing contextual and structural shortcomings of existing concepts for the use in inpatient treatment. The training targets depressive symptoms by changing (meta-) cognitive biases identified in both cognitive models of depression and basic research. D-MCT was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study.\n\nAim of the present randomized-controlled trial is to investigate the efficacy of D-MCT as an add-on intervention in inpatient treatment of depressed patients compared with a standard add-on group therapy (Positivity Training, PT). Based on a power analysis, the investigators target a sample size of 60 depressed patients, who will be randomized either to D-MCT or PT. Blind to diagnostic status, symptom level as well as cognitive biases will be assessed pre- and post-treatment (8 group sessions) as well as 3 months later (follow-up). Primary outcome parameter is severity of depressive symptoms measured with the HDRS total score (17-item version). Secondary outcome measures are self-assessed depression (BDI), dysfunctional beliefs (DAS), metacognitions (MCQ), self-esteem (RSE), and quality of life (WHOQOL-BREF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Major Depression according to DSM-IV (MINI Interview)\n* Diagnosis of Dysthymia according to DSM-IV (MINI Interview)\n\n * DSM-IV = The Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition, Text Revision (American Psychiatric Association, 2000)\n\nExclusion Criteria:\n\n* Lifetime psychotic symptoms (i.e., hallucinations, delusions, or bipolar disorder) according to DSM-IV (MINI Interview)\n* Current substance dependency according to DSM-IV (MINI Interview)'}, 'identificationModule': {'nctId': 'NCT02437357', 'briefTitle': 'A Trial on Metacognitive Training for Depression (D-MCT)', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'A Randomized-Controlled Trial on Metacognitive Training for Depression (D-MCT) - an New Group Intervention for Depressed Patients', 'orgStudyIdInfo': {'id': 'NWF-15/03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metacognitive Training', 'description': "D-MCT is conceptualized as a variant of cognitive behavioral therapy (CBT) that uses a metacognitive perspective to focus on the modification of cognitive biases by using creative and engaging strategies (e.g., multimedial presentation). The training seeks to enable group members to recognize and correct the often automatic and unconscious depressive thought patterns, in part by viewing this depressive thought process at a distance (i.e., depersonalizing). Besides dysfunctional assumptions about one's thought processes, more general cognitive biases, which have been identified by basic research are at the core of the D-MCT. Finally, dysfunctional coping-strategies (i.e., thought suppression, rumination as problem-solving) are discussed and modified.", 'interventionNames': ['Other: Metacognitive Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positivity Training', 'description': 'Positivity Training (PT) is a "euthymic therapy" group based on cognitive behavioral therapy (CBT) with a focus on the education and training of sensual enjoyment and pleasure. Aim of the training is to reduce depressive symptomatology by increasing the ability to enjoy and to (re-)install positive sensory experiences. Therefore, group members are informed about the impact of positive experiences on well-being and the awareness of the five senses is trained in different practical exercises (hearing, sight, smell, taste, and touch).', 'interventionNames': ['Other: Positivity Training']}], 'interventions': [{'name': 'Metacognitive Training', 'type': 'OTHER', 'description': '8 group sessions á 60 min', 'armGroupLabels': ['Metacognitive Training']}, {'name': 'Positivity Training', 'type': 'OTHER', 'description': '8 group sessions á 60 min', 'armGroupLabels': ['Positivity Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Marit Hauschildt, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}