Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT02538835
Status:
UNKNOWN
Last Update Posted:
2016-11-15
First Post:
2015-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Group Treatment for Depression: A Study of Metacognitive Therapy, Mindfulness and Support Groups
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099025', 'term': 'Mindfulness-Based Cognitive Therapy'}, {'id': 'D044382', 'term': 'Population Groups'}, {'id': 'D012657', 'term': 'Self-Help Groups'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-14', 'studyFirstSubmitDate': '2015-08-31', 'studyFirstSubmitQcDate': '2015-09-01', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline on Hamilton depression scale', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline on Hamilton depression scale', 'timeFrame': '32 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline on Becks depression inventory', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline on Becks depression inventory', 'timeFrame': '32 weeks'}, {'measure': 'Change from baseline on Becks Anxiety Inventory', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline on Becks Anxiety Inventory', 'timeFrame': '32 weeks'}, {'measure': 'Change from baseline on Ruminative Response Scale', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline on Ruminative Response Scale', 'timeFrame': '32 weeks'}, {'measure': 'Change from baseline on Metacognitive questionnaire', 'timeFrame': '8 weeks'}, {'measure': 'Change from baseline on Metacognitive questionnaire', 'timeFrame': '32 weeks'}]}, 'conditionsModule': {'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of metacognitive group therapy on depression compared to mindfulness groups and supportive groups. The participants, all with a history of depression and with current symptoms of depression, will be randomized to one of the three group interventions.', 'detailedDescription': 'Metacognitive therapy (MCT) show promising results in alleviating depressive symptoms and reducing relapse of depression. However studies of MCT as a group intervention is limited and higher quality studies of the effectiveness of MCT is warranted. The present study aim to produce more conclusive evidence on the effect of MCT comparing MCT in groups with both and active control group and mindfulness based cognitive therapy (MBCT), which together with pharmacotherapy is currently one of the preferred treatment choices. Currently pharmacotherapy, cognitive therapy and MBCT seem to help 40-58% of the patients efficiently. The current studies of MCT indicate that this intervention may help a higher proportion of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consent to participate\n* History of clinical depression\n* Current depressive symptoms\n* Verbal and cognitive abilities to complete the questionnaires during the study\n* Stable medication - if any medication is ordinated\n* Speaks fluently danish\n\nExclusion Criteria:\n\n* If criteria for psychosis, bipolar disorder or personality disorder is matched\n* known brain damage or mental retardation\n* substance abuse\n* women who are pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT02538835', 'briefTitle': 'The Effect of Group Treatment for Depression: A Study of Metacognitive Therapy, Mindfulness and Support Groups', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'The Effect of Group Treatment for Depression: A Randomised Controlled Study of Metacognitive Therapy, Mindfulness and Support Groups', 'orgStudyIdInfo': {'id': '46332'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metacognitive Therapy', 'interventionNames': ['Behavioral: Metacognitive therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness based cognitive therapy', 'interventionNames': ['Behavioral: Mindfulness based cognitive therapy, group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Support groups', 'interventionNames': ['Behavioral: Support groups']}], 'interventions': [{'name': 'Metacognitive therapy', 'type': 'BEHAVIORAL', 'description': 'Group format, 10-12 participants in each group. 8 weekly sessions of two hours each.', 'armGroupLabels': ['Metacognitive Therapy']}, {'name': 'Mindfulness based cognitive therapy, group', 'type': 'BEHAVIORAL', 'description': 'Group format, 10-12 participants in each group. 8 weekly sessions of two hours each following the manual described by Williams, Zindel \\& Segal.', 'armGroupLabels': ['Mindfulness based cognitive therapy']}, {'name': 'Support groups', 'type': 'BEHAVIORAL', 'description': 'Group format, 10-12 participants in each group. The sessions will only be of supportive character and will not focus on changing or restructuring thoughts, scripts or thought patterns. The format will follow a manual but compared to the other intervention groups the format allow participants to suggests themes for discussions.', 'armGroupLabels': ['Support groups']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5230', 'city': 'Odense', 'state': 'Southern Denmark', 'country': 'Denmark', 'contacts': [{'name': 'Mette E Andersen, PhD', 'role': 'CONTACT', 'email': 'melandersen@health.sdu.dk', 'phone': '65504625', 'phoneExt': '+45'}, {'name': 'Tonny Andersen, PhD', 'role': 'CONTACT', 'email': 'tandersen@health.sdu.dk', 'phone': '65502778', 'phoneExt': '+45'}], 'facility': 'University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Mette E Andersen, PhD', 'role': 'CONTACT', 'email': 'melandersen@health.sdu.dk', 'phone': '65504625', 'phoneExt': '+45'}, {'name': 'Tonny Andersen, PhD', 'role': 'CONTACT', 'email': 'tandersen@health.sdu.dk', 'phone': '65502778', 'phoneExt': '+45'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center for Kognitive Terapier og Supervision', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tonny Elmose Andersen, phd.', 'investigatorAffiliation': 'University of Southern Denmark'}}}}