Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT02403557
Status:
COMPLETED
Last Update Posted:
2016-03-02
First Post:
2015-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-delivered Cognitive Behaviour Therapy for Older Adults With Anxiety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014850', 'term': 'Waiting Lists'}], 'ancestors': [{'id': 'D001071', 'term': 'Appointments and Schedules'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-01', 'studyFirstSubmitDate': '2015-03-26', 'studyFirstSubmitQcDate': '2015-03-26', 'lastUpdatePostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'Two weeks pre treatment, two weeks post treatment and 12 months post treatment', 'description': 'Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire (PHQ)', 'timeFrame': 'Two weeks pre treatment, two weeks post treatment and 12 months post treatment', 'description': 'Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.'}, {'measure': 'The Generalized Anxiety Disorder 7-item Scale (GAD-7)', 'timeFrame': 'Two weeks pre treatment, two weeks post treatment and 12 months post treatment', 'description': 'Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.'}, {'measure': 'Quality of Life Inventory (QOLI)', 'timeFrame': 'Two weeks pre treatment, two weeks post treatment and 12 months post treatment', 'description': 'Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.'}, {'measure': 'Montgomery Åsberg Depression Rating Scale - Self Rated (MADRS-S)', 'timeFrame': 'Two weeks pre treatment, two weeks post treatment and 12 months post treatment', 'description': 'Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.'}, {'measure': 'Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM)', 'timeFrame': 'Two weeks pre treatment, two weeks post treatment and 12 months post treatment', 'description': 'Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.'}, {'measure': 'Cognitive Failures Questionnaire (CFQ)', 'timeFrame': 'Two weeks pre treatment, two weeks post treatment and 12 months post treatment'}, {'measure': 'Wisconsin Card Sorting Test-64 (WCST-64)', 'timeFrame': 'Two weeks pre treatment, two weeks post treatment and 12 months post treatment'}]}, 'conditionsModule': {'conditions': ['Anxiety', 'Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether tailored internet-administrated cognitive behaviour therapy (ICBT) is a feasible approach in the treatment of anxiety symptoms and comorbid depressive symptoms in older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have anxiety symptoms\n\nExclusion Criteria:\n\n* Suicidal ideation\n* Alcohol addiction\n* Other major primary psychiatric disorder\n* Ongoing psychological treatment'}, 'identificationModule': {'nctId': 'NCT02403557', 'briefTitle': 'Internet-delivered Cognitive Behaviour Therapy for Older Adults With Anxiety', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Individually-tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Older Adults With Anxiety and Depression: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GA-Forte-Older-Adults-Anx'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored Internet-delivered CBT', 'description': 'Tailored Internet-delivered CBT during 8 weeks.', 'interventionNames': ['Behavioral: Tailored Internet-delivered CBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist', 'description': 'Weekly check-up.', 'interventionNames': ['Behavioral: Waitlist']}], 'interventions': [{'name': 'Waitlist', 'type': 'BEHAVIORAL', 'description': 'Weekly check up.', 'armGroupLabels': ['Waitlist']}, {'name': 'Tailored Internet-delivered CBT', 'type': 'BEHAVIORAL', 'description': 'Tailored Internet-delivered CBT during 8 weeks.', 'armGroupLabels': ['Tailored Internet-delivered CBT']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gerhard Andersson', 'investigatorAffiliation': 'Linkoeping University'}}}}