Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-04-21 @ 2:55 PM
Study NCT ID:
NCT02261194
Status:
COMPLETED
Last Update Posted:
2016-11-15
First Post:
2014-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-14', 'studyFirstSubmitDate': '2014-10-02', 'studyFirstSubmitQcDate': '2014-10-06', 'lastUpdatePostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in depressive symptoms', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Depressive symptoms will be measured by the PHQ-9, a validated 9 item instrument.'}], 'secondaryOutcomes': [{'measure': 'Change in severity of anxiety symptoms', 'timeFrame': 'Baseline and 8 weeks', 'description': 'The GAD-7 can be used to establish probable diagnoses of generalized anxiety disorder as well as grade its severity (mild, moderate and severe).'}, {'measure': 'Change in self-efficacy', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Self-efficacy will be measured with a 4-item scale, adapted from a validated diabetes self-care self-efficacy scale. Scores range from 0-12.'}, {'measure': 'Change in life space', 'timeFrame': 'Baseline and 8 weeks', 'description': 'The Life Space Assessment asks about the spatial extent in which the participant has traveled over the last month. Scores range from 0-100.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['depression', 'age-related macular degeneration', 'self-care', 'self-help'], 'conditions': ['Depression', 'Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine the short-term effect of a self-care intervention on depression in patients with age-related macular degeneration or diabetic retinopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of wet or dry AMD or diabetic retinopathy\n* age 50 years and older\n* at least mild depressive symptoms (a score of 5 or more on the PHQ-9)\n* no legal blindness (visual acuity better than 20/200 in better eye).\n\nExclusion Criteria:\n\n* the current use of cognitive behavioural therapy\n* suicidal intent\n* ocular surgery during the study period (intravitreal anti-VEGF injections will be allowed, e.g. Lucentis)\n* cognitive impairment\n* inability to speak and understand French or English\n* profound hearing impairment.'}, 'identificationModule': {'nctId': 'NCT02261194', 'briefTitle': 'Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Maisonneuve-Rosemont Hospital'}, 'officialTitle': 'Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'Réseau Vision Freeman'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-Care Tools', 'description': 'The tool binder includes 3 core tools and 4 supplemental tools. The tools that will be provided include a variety of self-care approaches to manage depression including audio-visual, internet, and paper-based tools that might appeal to individuals with different learning styles. The 3 core tools consist of the Antidepressant Skills Workbook, a Mood Monitoring Tool, and a DVD on depression.', 'interventionNames': ['Behavioral: Self-Care Tools']}, {'type': 'NO_INTERVENTION', 'label': 'Delayed Self-Care Tools', 'description': 'This group will receive the self-care tools at the conclusion of the study.'}], 'interventions': [{'name': 'Self-Care Tools', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Self-Care Tools']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Maisonneuve-Rosemont Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Ellen E. Freeman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maisonneuve-Rosemont Hospital and University of Montreal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maisonneuve-Rosemont Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}, {'name': 'Fondation Antoine Turmel', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ellen Freeman', 'investigatorAffiliation': 'Maisonneuve-Rosemont Hospital'}}}}