Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT06065020
Status:
COMPLETED
Last Update Posted:
2025-02-20
First Post:
2023-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Community Intervention to Improve Depressive Symptoms Among Older Adults (VIDACTIVA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'We will try to mask the outcome assessor, but for the nature of the intervention, it will be difficult that outcome assessor remain blind.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2023-09-26', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': 'At baseline, at 14th and 22th week.', 'description': 'Measured by Patient Health Questionnaire - 9 (PHQ-9) \\[ minimum score: 0 ; maximum score: 27 \\] \\[More score = worse symptoms\\]'}], 'secondaryOutcomes': [{'measure': 'Anxiety symptoms', 'timeFrame': 'At baseline, at 14th and 22th week.', 'description': 'Measured by Generalised Anxiety Disorder - 7 (GAD-7) \\[min score: 0 , max score: 21\\] \\[more score, worse symptoms\\]'}, {'measure': 'Loneliness', 'timeFrame': 'At baseline, at 14th and 22th week.', 'description': 'Measured by the Three-Items Loneliness \\[min 0, max: 9\\] \\[more score, more lonely\\]'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['depression', 'aged', 'problem-solving'], 'conditions': ['Depression, Anxiety']}, 'referencesModule': {'references': [{'pmid': '41282139', 'type': 'DERIVED', 'citation': 'Otero-Oyague D, Lastra D, Patino V, Carrion I, Cruz-Riquelme T, Pollard SL, Parodi JF, Steinman L, Gallo JJ, Valle R, Castro N, Flores-Flores O. Community health workers fostering trust and engagement in a community-based intervention for depressive older adults in Peru: a qualitative study. Res Sq [Preprint]. 2025 Oct 19:rs.3.rs-7665993. doi: 10.21203/rs.3.rs-7665993/v1.'}, {'pmid': '39175082', 'type': 'DERIVED', 'citation': 'Cruz-Riquelme T, Zevallos-Morales A, Carrion I, Otero-Oyague D, Patino V, Lastra D, Valle R, Parodi JF, Pollard SL, Steinman L, Gallo JJ, Flores-Flores O. Pilot trial protocol: community intervention to improve depressive symptoms among Peruvian older adults. Pilot Feasibility Stud. 2024 Aug 22;10(1):112. doi: 10.1186/s40814-024-01540-1.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this pilot trial is to test how feasible is to conduct a large clinical trial that evaluate both implementation and effectiveness outcomes of a community-based interventions for older adults with depression in low-resource urban settings from Lima, Peru.\n\nThe main questions:\n\nIs the way we are planning the study, including those who are taking part and what they will do, good for a large study?\n\nIs the interventional package we are developing good the way it is, and can it be done the way we planned it?', 'detailedDescription': 'Participants who join will be split into two groups: one group will get the interventional program, and the other group will get standard care. In the interventional group, community health workers will meet with participants eight times to do activities and talk about how they feel. The standard group will have two visits where they will learn things about mental health.\n\nThe results of the study will help the researchers understand whether they can test the program in larger study. Additionally, see whether those participants in the interventional group feel better than those who are in the standard group.\n\nSample size: This is a pilot trial. No sample size calculations are needed because the objective is NOT to evaluate the effect of the intervention, but rather the feasibility of conducting a large-scale clinical trial. It is expected to enroll 64 participants (32 control group vs 32 intervention group). This number is based on previous formative study and training of community health workers.\n\nResearchers will collect basic information to assess feasibility for a larger trial, including:\n\n* Number of potential participants screened per month;\n* Number of participants enroled per month;\n* Average time from enrolment to randomisation.\n* Average time to reach enrolment goal\n* Proportion of eligible participants who enrol\n* Proportion of people who maintain the study in both groups.\n* Reasons for abandoning the study.\n* Visit durations'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having depressive symptoms (score equal to or greater than 6 on the Patient Health Questionnaire - PHQ 9).\n* Capacity to give consent.\n* Current residence in Villa El Salvador, Lima, Peru.\n\nExclusion Criteria:\n\n* Previous diagnosis of bipolar disorder\n* History of substance abuse\n* History of dissociative disorder, psychosis or dementia, or moderate memory and/or cognition problems.'}, 'identificationModule': {'nctId': 'NCT06065020', 'acronym': 'VIDACTIVA1', 'briefTitle': 'Community Intervention to Improve Depressive Symptoms Among Older Adults (VIDACTIVA)', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de San Martín de Porres'}, 'officialTitle': 'Pilot Trial of an Evidence-based Community Intervention to Improve Depressive Symptoms Among Peruvian Older Adults', 'orgStudyIdInfo': {'id': 'E10012021018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'VIDACTIVA program', 'interventionNames': ['Behavioral: VIDACTIVA sessions']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Standard Care', 'interventionNames': ['Behavioral: Standard Care']}], 'interventions': [{'name': 'VIDACTIVA sessions', 'type': 'BEHAVIORAL', 'description': 'Community health workers (CHWs) will delivered VIDACTIVA intervention that consists in 8 home-sessions, one hour duration, within a period of 14 weeks + 2 follow-up calls (monthly). In total, a period of 22 weeks.\n\nThe multicomponent intervention consist in the following:\n\nProblem-Solving Exercises: These are basic structured exercises aimed at training older individuals in problem-solving. This activity is centered around the older adult, meaning the older adults guides this activity, and the CHWs is a facilitator.\n\nPhysical Activation: This component involves planning and "scheduling" enjoyable activities (physical or social) that the older adult chooses based on their preferences and capabilities.\n\nEducation on Depressive Symptoms (psychoeducation)', 'armGroupLabels': ['Intervention group']}, {'name': 'Standard Care', 'type': 'BEHAVIORAL', 'description': 'Study fieldworkers will provide 2 educational sessions (45-60 min) about mental health at old age and participant will be guided to mental health community services (primary care centers). One session after the enrolment (week 1) and one at the 14th week.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lima', 'state': 'Lima Province', 'country': 'Peru', 'facility': 'Universidad de San Martin de Porres', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}], 'overallOfficials': [{'name': 'Oscar Flores-Flores, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de San Martin de Porres'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Expected to be available, once first manuscript is published. Expected 2025. For the next five years (2030).', 'ipdSharing': 'YES', 'description': 'Once first manuscript using data is published.', 'accessCriteria': 'We will share data based on reasonable request of a researcher.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de San Martín de Porres', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asociacion Benefica Prisma', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}