Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-01 @ 10:20 AM
Study NCT ID:
NCT04728204
Status:
COMPLETED
Last Update Posted:
2025-09-26
First Post:
2021-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-based Psychotherapy for Depressed Elderly
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', 'interventionModelDescription': 'Participants will be randomized to either control or intervention group. Participants in the control group will receive the same treatment after the intervention group is finished with the treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-01-23', 'lastUpdatePostDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Alcohol Use Disorders Identification Test (AUDIT)', 'timeFrame': 'Pre-treatment', 'description': 'AUDIT will be used for alcohol consumption and related risks assessment.'}], 'primaryOutcomes': [{'measure': 'Patient Health Questionnaire (PHQ-9)', 'timeFrame': 'Pre-treatment, week 8, 3, 12 and 24 months post-treatment', 'description': "Change from baseline in depression symptoms post-treatment (week 8), at three months, at 12 months and at 24 months post-treatment. Measure contains 9 questions that have to be responded to by choosing an answer from a 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'. Higher score indicates more severe symptoms."}, {'measure': 'Geriatric Depression Scale (GDS)', 'timeFrame': 'Pre-treatment, week 8, 3, 12 and 24 months post-treatment', 'description': "Change from baseline in depression symptoms post-treatment (week 8), at three months, at 12 months and at 24 months post-treatment. Measure contains 15 questions that have to be responded 'Yes' or 'No'. Higher score indicates more severe symptoms."}], 'secondaryOutcomes': [{'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Pre-treatment, week 8, 3, 12 and 24 months post-treatment', 'description': "Change from baseline in anxiety symptoms post-treatment (week 8), at three months, at 12 months and at 24 months post-treatment. Measure contains 7 questions that have to be responded to by choosing an answer from a 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'. Higher score indicates more severe symptoms."}, {'measure': 'The World Health Organisation- Five Well-Being Index (WHO-5)', 'timeFrame': 'Pre-treatment, week 8, 3, 12 and 24 months post-treatment', 'description': "Change from baseline in well-being post-treatment (week 8), at three months, at 12 months and at 24 months post-treatment. WHO-5 contains 5 statements about individuals well-being in the past two weeks. Respondents have to choose the best corresponding answer using a 6-item Likert scale where a score of 0 indicates 'At no time' and a score of 5 - 'All the time'. Higher score indicates higher well-being."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Internet-based cognitive behaviour therapy', 'Elderly', 'eHealth'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '34915909', 'type': 'DERIVED', 'citation': 'Eimontas J, Pakalniskiene V, Biliunaite I, Andersson G. A tailored Internet-delivered modular intervention based on cognitive behavioral therapy for depressed older adults: a study protocol for a randomized controlled trial. Trials. 2021 Dec 16;22(1):925. doi: 10.1186/s13063-021-05903-4.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of internet-based cognitive behavioral therapy (CBT) for depressed elderly.', 'detailedDescription': 'Individuals of age 60+ with symptoms of depression will be assessed before the study. At week 0, participants who meet eligibility requirements will be randomized either to intervention group which will participate in an 8-week internet-based modular CBT or to a delayed treatment control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* depressive symptoms\n* have access to a computer/tablet/smartphone and to the internet\n* have good knowledge of the Lithuanian language\n\nExclusion Criteria:\n\n* alcohol addiction\n* presently in any other psychological treatment\n* severe depression\n* suicidal ideation\n* significant change in psychiatric medication (during last 6 weeks)'}, 'identificationModule': {'nctId': 'NCT04728204', 'acronym': 'iPSYDE', 'briefTitle': 'Internet-based Psychotherapy for Depressed Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Vilnius University'}, 'officialTitle': 'Internet-based Cognitive Behavioral Therapy for Depressed Elderly: a Two-armed Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'iPSYDE_1_2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': '8 module, 8 week long internet-based intervention for reducing burden of depression', 'interventionNames': ['Behavioral: Depresijos terapija']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Participants randomized to the control group will be instructed to wait until the intervention group finishes the treatment and that they will be able to use the same intervention afterwards.'}], 'interventions': [{'name': 'Depresijos terapija', 'type': 'BEHAVIORAL', 'description': 'Intervention is based on the principles of cognitive behavioral therapy and culturally adapted to elderly Lithuanian population. The main purpose of the intervention is to reduce the symptoms of depression and increase psychological well-being. Intervention contains psychoeducation, examples, exercises and consultation with a psychologist.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LT-01513', 'city': 'Vilnius', 'state': 'Lithuania', 'country': 'Lithuania', 'facility': 'Vilnius University', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}], 'overallOfficials': [{'name': 'Jonas Eimontas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vilnius University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vilnius University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Linkoeping University', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Senior Research Fellow', 'investigatorFullName': 'Jonas Eimontas', 'investigatorAffiliation': 'Vilnius University'}}}}