Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2026-02-21 @ 12:30 AM
Study NCT ID:
NCT02112266
Status:
COMPLETED
Last Update Posted:
2016-05-10
First Post:
2014-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Depression Online Assessment and Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D000342', 'term': 'Affective Symptoms'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-09', 'studyFirstSubmitDate': '2014-04-04', 'studyFirstSubmitQcDate': '2014-04-09', 'lastUpdatePostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'change of therapy expectation during online-therapy', 'timeFrame': '3 time points screening + 3 months + 6 months', 'description': 'therapy expectation at screening and after intervention. Questionnaire: PECHI - Psychotherapy Expectations, Concerns, and Hopes Inventory'}, {'measure': 'alexithymia', 'timeFrame': 'screening', 'description': 'influences on outcome? Questionnaire: TAS - Toronto Alexithymia Scale'}, {'measure': 'satisfaction with current and former therapies and influence on decision for online therapy', 'timeFrame': 'screening', 'description': 'adapted version of ZUF-8 (= "Zufriedenheitsfragebogen mit der Behandlung" english version CSQ- client satisfaction questionnaire) for different experiences with therapy (e.g. for depression, for other psychiatric illnesses)'}, {'measure': 'sense of coherence', 'timeFrame': 'screening', 'description': 'influencing outcome? measured with SOC-13 -Sense of Coherence Scale'}, {'measure': 'changes in sense of coherence', 'timeFrame': '+ 3 months after screening (post) and + 6 months after post', 'description': 'measured with SOC-13 does online-therapy helps to develop a better SOC?'}, {'measure': 'changes alexithymia', 'timeFrame': '+ 3 months after screening (post) , + 6 months after post', 'description': 'Trait and state characteristics of alexithymia in depression measured with TAS-20'}], 'primaryOutcomes': [{'measure': 'Change of Quality of life', 'timeFrame': 'at screening, post treatment (3 months) and follow-up (6 months after post)', 'description': 'WHOQol brev - WHO quality of life questionnaire short form'}], 'secondaryOutcomes': [{'measure': 'change of Sleep quality', 'timeFrame': 'screening, post treatment (3 months), follow-up(6 months after post)', 'description': 'Questionnaire PSQI - Pittsburgh sleep quality index'}, {'measure': 'change of severity of depression', 'timeFrame': '3 time points screening, + 3 months + 6 months', 'description': 'patients receive mail support or not during follow up. Questionnaire: BDI - Beck Depression Inventory'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'online therapy', 'cognitive behavioural therapy', 'quality of life', 'alexithymia', 'therapy expectation and satisfaction'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'One Aim of the current study is to better understand why some patients suffering from depression do not seek professional help by doctors but in the internet.\n\nFurthermore patients with depression will receive Online Therapy for depression. Aim of this part of the study is to investigate whether quality of life changes accordingly to improvement of symptoms after online therapy.', 'detailedDescription': '* German speaking patients can register online. There will be no side visits.\n* After screening: patients which meet inclusion criteria and no exclusion criteria can take part in online therapy for depression.\n* After 12 weeks 2nd online survey. After this survey patients can use the program the following 6 months (follow-up)\n* After 6 months 3rd and last online-survey.\n* According to the aims of the study cross-sectional as well as longitudinal data will be obtained and analysed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* German language\n* depression at least slight according BDI (Beck depression inventory) and at least 2 weeks\n\nExclusion Criteria:\n\n* severe depression according BDI\n* suicidal ideation\n* alcohol or drug dependency\n* history of psychotic symptoms\n* history of bipolar disorder or previous mania\n* current in-patient care or semi-residential treatment'}, 'identificationModule': {'nctId': 'NCT02112266', 'briefTitle': 'Depression Online Assessment and Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Online Assessment for Therapy Expectation and Quality of Life and Online Therapy of Depression', 'orgStudyIdInfo': {'id': 'ICBT'}, 'secondaryIdInfos': [{'id': '2013-0542', 'type': 'OTHER', 'domain': 'KEK Zurich CH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'no mail support', 'description': 'no mail support during follow-up', 'interventionNames': ['Other: no mail support']}, {'type': 'OTHER', 'label': 'mail support', 'interventionNames': ['Other: Mail support']}], 'interventions': [{'name': 'Mail support', 'type': 'OTHER', 'description': 'between post treatment and follow up two groups: one with unspecific mail support every 2 weeks one without', 'armGroupLabels': ['mail support']}, {'name': 'no mail support', 'type': 'OTHER', 'description': 'follow-up without mail support', 'armGroupLabels': ['no mail support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich - only online recruitment', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'S Weidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USZ, UZH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Makora', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}