Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT01517503
Status:
COMPLETED
Last Update Posted:
2019-07-30
First Post:
2011-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acceptance and Commitment Therapy Versus Cognitive Therapy for the Treatment of Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-26', 'studyFirstSubmitDate': '2011-11-08', 'studyFirstSubmitQcDate': '2012-01-20', 'lastUpdatePostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QUICK INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY (QIDS-SR)', 'timeFrame': 'pre-treatment, post-treatment, 6 and 12 months follow-up', 'description': 'Change from pre-treatment to post-treatment, 6 months follow-up and 12 months follow-up'}, {'measure': 'Hamilton Rating Scale for Depression', 'timeFrame': 'pre-treatment, post-treatment', 'description': 'Change from pre-treatment to post-treatment.'}], 'secondaryOutcomes': [{'measure': 'Decentering subscale of the Experiences Questionnaire', 'timeFrame': 'Pre-treatment, in-treatment, and 6 and 12 months follow-up.', 'description': 'Change between sessions and to follow-up.'}, {'measure': 'Acceptance and Action Questionnaire', 'timeFrame': 'Pre-treatment, in-treatment, and 6 and 12 months follow-up.', 'description': 'Change between sessions and to follow-up.'}, {'measure': 'Dysfunctional Attitude Scale-revised', 'timeFrame': 'Pre-treatment, in-treatment, and 6 and 12 months follow-up', 'description': 'Change between sessions to follow-up.'}, {'measure': 'Working Alliance Inventory', 'timeFrame': '3. session'}, {'measure': 'Eurohis Quality of Life Scale', 'timeFrame': 'Pre-, post-treatment, 6 and 12 months follow-up', 'description': 'Change pre-treatment to post-treatment and to follow-up.'}, {'measure': 'Relationship Scales', 'timeFrame': 'Pre-, post-treatment, 12 months follow-up', 'description': 'Change pre-treatment to post-treatment and to follow-up.'}, {'measure': 'Implicit Attitude Test', 'timeFrame': 'Pre- and posttreatment', 'description': 'Change pre-treatment to post-treatment'}, {'measure': 'Structured Clinical Interview for DSM-IV (Major Depression Module)', 'timeFrame': 'Pre-treatment and post-treatment.', 'description': 'Change in diagnosis of Major Depression Disorder from pre-treatment to post-treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '33446152', 'type': 'DERIVED', 'citation': 'A-Tjak JGL, Morina N, Topper M, Emmelkamp PMG. One year follow-up and mediation in cognitive behavioral therapy and acceptance and commitment therapy for adult depression. BMC Psychiatry. 2021 Jan 14;21(1):41. doi: 10.1186/s12888-020-03020-1.'}, {'pmid': '32264845', 'type': 'DERIVED', 'citation': 'A-Tjak JGL, Morina N, Boendermaker WJ, Topper M, Emmelkamp PMG. Explicit and implicit attachment and the outcomes of acceptance and commitment therapy and cognitive behavioral therapy for depression. BMC Psychiatry. 2020 Apr 7;20(1):155. doi: 10.1186/s12888-020-02547-7.'}]}, 'descriptionModule': {'briefSummary': 'The study will investigate the effectiveness of Cognitive Therapy and Acceptance and Commitment Therapy in a randomized controlled trial among patients with Major Depressive Disorder in routine clinical practice. Furthermore, the study will investigate whether each specific treatment approach is mediated by its proposed theoretical mechanism.', 'detailedDescription': 'The current study aims at investigating the effectiveness of Cognitive Therapy and Acceptance and Commitment Therapy in a randomized controlled trial among patients with MDD in routine clinical practice. Further, the study will investigate whether each specific treatment approach is mediated by its proposed theoretical mechanism. Patients have to meet diagnostic criteria for nonpsychotic MDD as determined by the Structured Interview for DSM-IV. Each client will receive either Cognitive Therapy or Acceptance and Commitment Therapy that will last between 16 to 20 sessions. Based on previous results, it is expected that both treatment forms will prove beneficial for the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Meeting DSM-IV criteria for MDD\n2. Between the ages of 18 and 65-years-old\n3. Having sufficient fluency in Dutch to complete treatment and research protocol\n\nExclusion Criteria:\n\n1. DSM-IV criteria for bipolar disorder (past or present)\n2. Psychotic disorders\n3. Substance dependence disorders (current or within the past 6 months), or\n4. Organic brain syndrome.\n5. Borderline or antisocial personality disorder'}, 'identificationModule': {'nctId': 'NCT01517503', 'briefTitle': 'Acceptance and Commitment Therapy Versus Cognitive Therapy for the Treatment of Major Depressive Disorder', 'organization': {'class': 'OTHER', 'fullName': 'VU University of Amsterdam'}, 'officialTitle': 'Acceptance and Commitment Therapy vs. Cognitive Therapy for the Treatment of Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'METC 10/103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Therapy (CT)', 'description': 'Cognitive Therapy (CT)', 'interventionNames': ['Behavioral: Cognitive Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Acceptance and Commitment Therapy (ACT)', 'description': 'Acceptance and Commitment Therapy (ACT)', 'interventionNames': ['Behavioral: Acceptance and Commitment Therapy']}], 'interventions': [{'name': 'Cognitive Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive behavior therapy; cognitive behaviour therapy.'], 'description': "This interventions will target: (a) behavioral dysfunction, (b) situation-specific negative thinking and cognitive distortions, and (c) underlying dysfunctional beliefs or cognitions assumed to be related to the patient's current depression and risk of future depression. A maximum of 20 45-55 minute sessions will be provided, with sessions generally held weekly for the first 8 sessions and once every two weeks for the next 8 sessions.", 'armGroupLabels': ['Cognitive Therapy (CT)']}, {'name': 'Acceptance and Commitment Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Mindfulness-based interventions'], 'description': 'This interventions will use (a) acceptance, (b) commitment, (c) mindfulness, and (d) behavior change processes to produce reduction of depressive symptoms. A maximum of 20 45-55 minute sessions will be provided, with sessions generally held weekly for the first 8 sessions and once every two weeks for the next 8 sessions.', 'armGroupLabels': ['Acceptance and Commitment Therapy (ACT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1500 AE', 'city': 'Zaandam', 'country': 'Netherlands', 'facility': 'PsyQ', 'geoPoint': {'lat': 52.43854, 'lon': 4.82643}}], 'overallOfficials': [{'name': 'Paul MG Emmelkamp, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Amsterdam'}, {'name': 'Nexhmedin Morina, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Amsterdam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VU University of Amsterdam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Paul M.G.Emmelkamp', 'investigatorAffiliation': 'VU University of Amsterdam'}}}}