Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-06 @ 6:20 AM
Study NCT ID:
NCT03353493
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2017-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Mindfulness-Based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants are masked at baseline assessment to treatment allocation. Outcome assessors are masked to treatment allocation.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised to Mindfulness-based cognitive therapy plus treatment as usual, or treatment as usual.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-04', 'studyFirstSubmitDate': '2017-09-08', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'fMRI BOLD secondary and whole brain analyses', 'timeFrame': 'Baseline and 8 weeks', 'description': 'fMRI BOLD whole brain analyses (data-driven) and secondary subcortical seed-based analyses: As seeds we preselect hippocampus, the amygdala and striatum'}, {'measure': 'Global Gene expression with focus on genes involved in mitochondrial function, the respiratory chain.', 'timeFrame': 'Baseline and 8 weeks', 'description': 'HG-U133 Plus 2.0 GeneChip (Affymetrix)'}], 'primaryOutcomes': [{'measure': 'Change in neural connectivity', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Neural connectivity will be measured with functional magnetic resonance (fMRI). Selected a priory networks for seed-based analyses: Default mode Network and Salience Network'}], 'secondaryOutcomes': [{'measure': 'Change in mindfulness skills', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Five Factor Mindfulness Questionnaire (FFMQ)'}, {'measure': 'Change in decentering', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Experiences Questionaire (EQ)'}, {'measure': 'Change in rumination', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Rumination Response Scale (RRS)'}, {'measure': 'Change in emotional processing bias', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Facial Expression Recognition task (FERT)'}, {'measure': 'Change in interoceptive awareness', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Multidimensional Assessment of Interoceptive Awareness (MAIA)'}, {'measure': 'Change in perceived stress', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Perceived Stress Scale (PSS)'}, {'measure': 'Time to relapse or recurrence of depression', 'timeFrame': '12 months follow up', 'description': 'Structured clinical interview for DSM-IV'}, {'measure': 'Change in depressive symptoms', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Quick Inventory for Depressive Symptomology (QIDS-SR)'}, {'measure': 'Change in interleukin gene expression', 'timeFrame': 'Baseline and 8 weeks', 'description': 'IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13,'}, {'measure': 'Change in interleukin protein expression', 'timeFrame': 'Baseline and 8 weeks', 'description': 'IL-1, IL-2, IL-4,IL-6, IL-8, IL-10, IL-12p70, IL-13,'}, {'measure': 'Change in gene expression of norepinephrine transporter', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Norepinephrine transporter (NET)'}, {'measure': 'Change in gene expression of glutamate receptor', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Glutamate receptor (GRM7)'}, {'measure': 'Change in gene expression of TNF', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Change in gene expression of tumor necrosis factor (previous nomenclature TNF-alfa)'}, {'measure': 'Change in protein expression of tumor necrosis factor', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Tumor necrosis factor'}, {'measure': 'cRP expression', 'timeFrame': 'Baseline and 8 weeks', 'description': 'c reactive protein expression'}, {'measure': 'Change in NF-kB gene expression', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Nuclear factor kappa-light-chain-enhancer of activated B cells gene expression'}, {'measure': 'Change in NF-kB protein expression', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Nuclear factor kappa-light-chain-enhancer of activated B cells protein expression'}, {'measure': 'Change in INFG gene expression', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Interferon gamma gene expresison'}, {'measure': 'Change in Interferon gamma protein expression', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Interferon gamma protein expresison'}, {'measure': 'Mitochondrial DNA Copy Number', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Copy number is assessed using quantitative real-time-PCR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness-Based Cognitive Therapy', 'Neural, psychological and molecular mechanisms'], 'conditions': ['Major Depressive Disorder, Recurrent']}, 'referencesModule': {'references': [{'pmid': '36328822', 'type': 'DERIVED', 'citation': "van der Velden AM, Scholl J, Elmholdt EM, Fjorback LO, Harmer CJ, Lazar SW, O'Toole MS, Smallwood J, Roepstorff A, Kuyken W. Mindfulness Training Changes Brain Dynamics During Depressive Rumination: A Randomized Controlled Trial. Biol Psychiatry. 2023 Feb 1;93(3):233-242. doi: 10.1016/j.biopsych.2022.06.038. Epub 2022 Jul 22."}], 'seeAlsoLinks': [{'url': 'http://interactingminds.au.dk/projects/mindfulness-and-the-prevention-of-depression/', 'label': 'Study website'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to investigate neural mechanisms and predictors of treatment outcome in Mindfulness-Based Cognitive Therapy (MBCT) for recurrent Major Depressive Disorder.', 'detailedDescription': 'AIM AND HYPOTHESES\n\nThe primary aim is to investigate treatment mechanisms of MBCT and markers of relapse risk.\n\nControlled design:\n\nFirst, we aim to first investigate the effect of treatment on clinical outcomes in the controlled design post treatment and at 3 months follow up. Second, we will run mediation analyses of hypothesized mechanisms (increased mindfulness skills, decentering, interoceptive and decreased rumination, and change in neural connectivity in a priori networks), and finally check for moderating influences of vulnerability markers (childhood trauma, no. episodes of depression and residual symptoms).\n\nProspective design:\n\nWe aim to investigate predictors of relapse risk at 12 month follow treatment using i) baseline markers and ii) mechanism outcomes that change significantly due to treatment, and iii) check for moderating influences of vulnerability markers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age above 18 years\n2. Meeting DSM-IV criteria for a history of recurrent Major Depressive Disorder (MDD) with or without a current episode of depression\n3. Recurrent MDD evaluated a being the primary disorder.\n4. Danish literacy\n\nExclusion Criteria:\n\n1. A history of schizophrenia, schizoaffective disorder, bipolar disorder, current severe substance abuse, organic mental disorder, current/past psychosis, pervasive developmental delay, persistent antisocial behaviour, persistent self-injury requiring clinical management/therapy\n2. Formal concurrent psychotherapy\n3. Previous Mindfulness-Based Cognitive Therapy/Mindfulness-Based Stress Reduction\n4. Anti-psychotic medication and benzodiazepines\n5. Standard exclusion criteria for undergoing magnetic resonance imaging (MRI) procedures for research purposes, i.e., claustrophobia, pregnancy, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, non-MR-compatible implants or devices.'}, 'identificationModule': {'nctId': 'NCT03353493', 'briefTitle': 'Mechanisms of Mindfulness-Based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Neural, Molecular and Psychological Mechanisms and Predictors of Treatment Response to Mindfulness-based Cognitive Therapy in the Treatment of Recurrent Major Depressive Disorder', 'orgStudyIdInfo': {'id': '314 #2016-051-000001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MBCT + TAU', 'description': 'Mindfulness-based Cognitive Therapy (MBCT) a 8 week group based intervention delivered according to the protocol by Segal, Williams and Teasdale (2013) plus treatment as usual (TAU) . TAU is restricted to antidepressant medication and no psychological therapy.', 'interventionNames': ['Behavioral: MBCT', 'Other: TAU']}, {'type': 'OTHER', 'label': 'TAU', 'description': 'Treatment as Usual (TAU). TAU is restricted to antidepressant medication and no psychological therapy.', 'interventionNames': ['Other: TAU']}], 'interventions': [{'name': 'MBCT', 'type': 'BEHAVIORAL', 'description': 'Mindfulness-Based Cognitive Therapy (MBCT) is an 8 week manualised group intervention. MBCT will be delivered according to the manual by Segal, Williams \\& Teasdale (2013).', 'armGroupLabels': ['MBCT + TAU']}, {'name': 'TAU', 'type': 'OTHER', 'description': 'Treatment as usual (TAU)', 'armGroupLabels': ['MBCT + TAU', 'TAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Anne Maj van der Velden, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oxford', 'class': 'OTHER'}, {'name': 'VIA University College', 'class': 'OTHER'}, {'name': 'University of York', 'class': 'OTHER'}, {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD fellow', 'investigatorFullName': 'Anne Maj van der Velden', 'investigatorAffiliation': 'University of Aarhus'}}}}