Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT01544205
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2012-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurofeedback as a Treatment Tool 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-05', 'studyFirstSubmitDate': '2012-02-23', 'studyFirstSubmitQcDate': '2012-02-28', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at the end of intervention (after 5th session)', 'timeFrame': 'Baseline, end of intervention (appr. 2 months)'}, {'measure': 'Change from Baseline in the Self-efficacy-scale (general subscale: GSE) at follow-up', 'timeFrame': 'Baseline, 3-month follow-up'}, {'measure': 'Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at the end of intervention (after 5th session)', 'timeFrame': 'Baseline, end of intervention (appr. 2 months)'}, {'measure': 'Change from Baseline in the Self-efficacy-scale (social subscale: SSE) at follow-up', 'timeFrame': 'Baseline, 3-month follow-up'}, {'measure': 'Change from Baseline in the Thought control questionnaire (TCQ) at the end of intervention (after 5th session)', 'timeFrame': 'Baseline, end of intervention (appr. 2 months)'}, {'measure': 'Change from Baseline in the Thought control questionnaire (TCQ) at follow-up', 'timeFrame': 'Baseline, 3-month follow-up'}, {'measure': 'Change from Baseline in the Thought control ability questionnaire (TCAQ) at the end of intervention (after 5th session)', 'timeFrame': 'Baseline, end of intervention (appr. 2 months)'}, {'measure': 'Change from Baseline in the Thought control ability questionnaire (TCAQ) at follow-up', 'timeFrame': 'Baseline, 3-month follow-up'}, {'measure': 'Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at the end of intervention (after 5th session)', 'timeFrame': 'Baseline, end of intervention (appr. 2 months)'}, {'measure': 'Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BAS scale, at follow-up', 'timeFrame': 'Baseline, 3-month follow-up'}, {'measure': 'Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at the end of intervention (after 5th session)', 'timeFrame': 'Baseline, end of intervention (appr. 2 months)'}, {'measure': 'Change from Baseline in the Behavioural inhibition system and behavioural activation system (BIS/BAS), BIS scale, at follow-up', 'timeFrame': 'Baseline, 3-months follow-up'}, {'measure': 'Change from Baseline in health service resource use as measured with a Resource Use Questionnaire', 'timeFrame': 'Baseline, 3-months follow-up'}, {'measure': 'Change from before to after scan in the Profile of Mood States (POMS)', 'timeFrame': 'Before and after each scanning session (appr. 2 months: session 1: week 1; session 2: week 2; session 3: week 3; session 4: week 4; session 5: week 8)', 'description': 'Measure to address any imminent changes in mood state.'}, {'measure': 'Relation between upregulation ability of target areas (as obtained by functional MRI analysis) and perceived self control', 'timeFrame': 'Integrating imaging and psychometric data across the intervention period (appr. 2 months)', 'description': 'Analysis of the relationship between scores on the self-efficacy scales, thought control questionnaire (TCQ), thought control ability questionnaire (TCAQ) and the behavioural inhibition system and behavioural activation system (BIS/BAS) scales and fMRI data.'}], 'primaryOutcomes': [{'measure': 'Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at the end of intervention (after 5th session)', 'timeFrame': 'Before start trial (baseline), after intervention (appr. 2 months)'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Hamilton Depression Rating Scale (HDRS) score at follow-up', 'timeFrame': 'Baseline, 3-month follow-up'}, {'measure': 'Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at the end of intervention (after 5th session)', 'timeFrame': 'Baseline, end of intervention (appr. 2 months)'}, {'measure': 'Change from Baseline in Hospital Anxiety and Depression Scale (HADS) anxiety score at follow-up', 'timeFrame': 'Baseline, 3-month follow-up'}, {'measure': 'Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at the end of intervention (after 5th session)', 'timeFrame': 'Baseline, end of intervention (appr. 2 months)'}, {'measure': 'Change from Baseline in Hospital Anxiety and Depression Scale (HADS) depression score at follow-up', 'timeFrame': 'Baseline, 3-month follow-up'}, {'measure': 'Change from Baseline in the Quality of Life Scale (QOLS) at the end of intervention (after 5th session)', 'timeFrame': 'Baseline, end of intervention (appr. 2 months)'}, {'measure': 'Change from Baseline in the Quality of Life Scale (QOLS) at follow-up', 'timeFrame': 'Baseline, 3-month follow-up'}, {'measure': 'Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at the end of intervention (after 5th session)', 'timeFrame': 'Baseline, end of intervention (appr. 2 months)'}, {'measure': 'Change from Baseline in the European Quality of Life-5 dimensions scale (EQ-5D) at follow-up', 'timeFrame': 'Baseline, 3-month follow-up'}]}, 'conditionsModule': {'conditions': ['Unipolar Depression']}, 'referencesModule': {'references': [{'pmid': '19646532', 'type': 'BACKGROUND', 'citation': 'Johnston SJ, Boehm SG, Healy D, Goebel R, Linden DE. Neurofeedback: A promising tool for the self-regulation of emotion networks. Neuroimage. 2010 Jan 1;49(1):1066-72. doi: 10.1016/j.neuroimage.2009.07.056. Epub 2009 Jul 29.'}, {'pmid': '21264651', 'type': 'BACKGROUND', 'citation': 'Johnston S, Linden DE, Healy D, Goebel R, Habes I, Boehm SG. Upregulation of emotion areas through neurofeedback with a focus on positive mood. Cogn Affect Behav Neurosci. 2011 Mar;11(1):44-51. doi: 10.3758/s13415-010-0010-1.'}, {'pmid': '26088117', 'type': 'DERIVED', 'citation': 'Fovet T, Jardri R, Linden D. Current Issues in the Use of fMRI-Based Neurofeedback to Relieve Psychiatric Symptoms. Curr Pharm Des. 2015;21(23):3384-94. doi: 10.2174/1381612821666150619092540.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate whether neurofeedback delivered via functional magnetic resonance imaging signals can be used to train depressed patients to self-regulate emotion networks and whether this improves clinical symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* major depressive disorder (MDD) diagnosis\n* stable antidepressant dose medication\n\nExclusion Criteria:\n\n* Other physical or psychiatric disorders\n* Current substance abuse\n* Current psychotherapy or other specific intervention\n* Exclusion criteria applicable to MRI'}, 'identificationModule': {'nctId': 'NCT01544205', 'acronym': 'NFD', 'briefTitle': 'Neurofeedback as a Treatment Tool for Depression', 'organization': {'class': 'OTHER', 'fullName': 'Cardiff University'}, 'officialTitle': 'fMRI Based Neurofeedback as a Treatment Method for Depression', 'orgStudyIdInfo': {'id': 'SPON927-11'}, 'secondaryIdInfos': [{'id': 'G 1100629', 'type': 'OTHER_GRANT', 'domain': 'MRC'}, {'id': 'HS/10/25', 'type': 'OTHER_GRANT', 'domain': 'NISCHR'}, {'id': '11/WA/0106', 'type': 'OTHER', 'domain': 'NHS Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emotion network up-regulation', 'description': 'Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to positive affective pictures (as identified during a functional localiser scan).', 'interventionNames': ['Other: fMRI-based neurofeedback']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Place processing network up-regulation', 'description': 'Participants use fMRI-based neurofeedback to train the upregulation of brain areas that respond to place and house pictures (as identified during a functional localiser scan).', 'interventionNames': ['Other: fMRI-based neurofeedback']}], 'interventions': [{'name': 'fMRI-based neurofeedback', 'type': 'OTHER', 'description': '5 sessions lasting one hour each', 'armGroupLabels': ['Emotion network up-regulation', 'Place processing network up-regulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF103AT', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'CUBRIC', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'CF14 4XN', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'School of Medicine, Cardiff University', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'David E Linden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiff University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardiff University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Council', 'class': 'OTHER_GOV'}, {'name': 'National Institute for Social Care and Health Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Translational Neuroscience', 'investigatorFullName': 'David Linden', 'investigatorAffiliation': 'Cardiff University'}}}}