Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-01 @ 12:51 PM
Study NCT ID:
NCT01324050
Status:
COMPLETED
Last Update Posted:
2011-08-02
First Post:
2011-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-delivered Psychodynamic Therapy for Depression
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-01', 'studyFirstSubmitDate': '2011-03-25', 'studyFirstSubmitQcDate': '2011-03-25', 'lastUpdatePostDateStruct': {'date': '2011-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': 'Two weeks before the treatment starts'}, {'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': 'At treatment start (0 weeks)'}, {'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': 'At treatment termination (10 weeks)'}], 'secondaryOutcomes': [{'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'Two weeks before the treatment starts'}, {'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'At treatment termination (10 weeks)'}, {'measure': 'Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)', 'timeFrame': 'Two weeks before treatment starts'}, {'measure': 'Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)', 'timeFrame': 'At treatment termination (10 weeks)'}, {'measure': 'Quality of Life Inventory (QOLI)', 'timeFrame': 'Two weeks before treatment starts'}, {'measure': 'Quality of Life Inventory (QOLI)', 'timeFrame': 'At treatment termination (10 weeks)'}, {'measure': 'Patient Health Questionnaire 9 (PHQ-9)', 'timeFrame': 'Two weeks before treatment starts'}, {'measure': 'Patient Health Questionnaire 9 (PHQ-9)', 'timeFrame': 'At treatment termination (10 weeks)'}, {'measure': 'Generalised Anxiety Disorder Assessment 7 (GAD-7)', 'timeFrame': 'Two weeks before treatment starts'}, {'measure': 'Generalised Anxiety Disorder Assessment 7 (GAD-7)', 'timeFrame': 'At treatment termination (10 weeks)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '24139066', 'type': 'DERIVED', 'citation': 'Johansson R, Nyblom A, Carlbring P, Cuijpers P, Andersson G. Choosing between Internet-based psychodynamic versus cognitive behavioral therapy for depression: a pilot preference study. BMC Psychiatry. 2013 Oct 18;13:268. doi: 10.1186/1471-244X-13-268.'}, {'pmid': '22741027', 'type': 'DERIVED', 'citation': 'Johansson R, Ekbladh S, Hebert A, Lindstrom M, Moller S, Petitt E, Poysti S, Larsson MH, Rousseau A, Carlbring P, Cuijpers P, Andersson G. Psychodynamic guided self-help for adult depression through the internet: a randomised controlled trial. PLoS One. 2012;7(5):e38021. doi: 10.1371/journal.pone.0038021. Epub 2012 May 29.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with mild to moderate major depression and compare its efficacy to an active control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Major Depressive Disorder\n* 15 or more on MADRS-S\n\nExclusion Criteria:\n\n* Severe depression (more than 35 on MADRS-S or based on interview)\n* Severe psychiatric condition (e.g. psychosis or bipolar disorder)\n* Suicidal (measured in diagnostic interview)\n* Changed medication during the last three months'}, 'identificationModule': {'nctId': 'NCT01324050', 'briefTitle': 'Internet-delivered Psychodynamic Therapy for Depression', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Internet-delivered Psychodynamic Therapy for Depression: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GA-DEP2011-PDT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet-based Psychodynamic Therapy', 'interventionNames': ['Behavioral: Internet-delivered psychodynamic therapy for depression']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Internet-delivered therapist support', 'interventionNames': ['Behavioral: Internet-delivered therapist support']}], 'interventions': [{'name': 'Internet-delivered psychodynamic therapy for depression', 'type': 'BEHAVIORAL', 'description': 'This intervention contains 9 text-based self-help modules. These modules contain material inspired by psychoanalytic theory about identifying reoccurring patterns in life among other things. In addition to the self-help modules, 10-15 minutes of therapist contact is given every week. In total, the intervention will last for 10 weeks.', 'armGroupLabels': ['Internet-based Psychodynamic Therapy']}, {'name': 'Internet-delivered therapist support', 'type': 'BEHAVIORAL', 'description': 'This intervention contains 1 text-based self-help module, which is mainly based on information on depression. In addition to this text, the participants in this group gets 10-15 minutes of therapist contact every week. In the conversation with the therapist, the participant informs the therapist about the activities during the week. This intervention is considered to be a form of support. In total, the intervention will last for 10 weeks.', 'armGroupLabels': ['Internet-delivered therapist support']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linköping University, Department of Behavioral Sciences and Learning', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linköping University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Gerhard Andersson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Behavioral Sciences and Learning, Linköping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Gerhard Andersson/Professor', 'oldOrganization': 'Linkoeping University'}}}}