Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-31 @ 11:26 PM
Study NCT ID:
NCT06950567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2025-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effectiveness of a Psychoeducational Intervention on Benzodiazepine Use in the Population Over 64 Years Old in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The minimal intervention will consist of sending a "Benzoletter" to each participant\'s mailing address. This includes a personalized letter signed by their Family Doctor, an explanatory leaflet on how to gradually reduce benzodiazepine use, and infographics on sleep hygiene, stress, and anxiety.\n\nAmong the participants, 45 will form the control group, while 24 will be part of the intervention group, which will also receive psychoeducational sessions and therapeutic exercises.\n\nThe effectiveness of both interventions will be evaluated after six months.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2025-04-11', 'studyFirstSubmitQcDate': '2025-04-25', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who have stopped taking benzodiazepines and/or have reduced their consumption measured in mg/week.', 'timeFrame': 'From the start of the intervention to six months afterward.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Benzodiazepines Deprescribing']}, 'descriptionModule': {'briefSummary': 'The objective of this pragmatic, multicenter, randomized controlled clinical trial is to determine whether an educational intervention regarding benzodiazepine use can reduce the consumption and/or dosage of these drugs in individuals over 64 years old.\n\nIt aims to provide knowledge and skills to help participants tolerate or reduce discomfort, enabling them to begin decreasing or discontinuing benzodiazepine (BZD) use.\n\nThe focus is on the effect of combined care, but the implementation of this approach is also assessed, providing valuable insights for further health developments in Primary Care.\n\nResearchers will compare a minimal intervention, consisting of sending a "Benzoletter" to each participant\'s mailing address, with an intensive intervention that additionally includes psychoeducational sessions and therapeutic exercises.\n\nParticipants in the intervention group will attend sessions at the Primary Care Center for a total duration of eight weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People over 64 years old who have been using benzodiazepines for a period of three months or more.\n* People with an active diagnosis of anxiety and/or insomnia.\n\nExclusion Criteria:\n\n* People with psychiatric comorbidities, dementia, epilepsy, included in the home care program (ATDOM), institutionalized, or in palliative care.\n* People with no possibility of contact or language barriers.\n* People with difficulty traveling to the Primary Care Center (CAP).'}, 'identificationModule': {'nctId': 'NCT06950567', 'acronym': 'BENZOS-AP', 'briefTitle': 'Evaluation of the Effectiveness of a Psychoeducational Intervention on Benzodiazepine Use in the Population Over 64 Years Old in Primary Care', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'Evaluation of the Effectiveness of a Psychoeducational Intervention on Benzodiazepine Use in the Population Over 64 Years Old in Primary Care', 'orgStudyIdInfo': {'id': '4R24/159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'control', 'description': 'Mailing a letter by postal mail', 'interventionNames': ['Other: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental', 'description': 'Mailing a letter by postal mail along with psycho-educational intervention and therapeutic activity.', 'interventionNames': ['Other: psycho-educational intervention and therapeutic activity']}], 'interventions': [{'name': 'psycho-educational intervention and therapeutic activity', 'type': 'OTHER', 'description': 'The objective is to provide knowledge and skills to tolerate/reduce discomfort so that they can begin to reduce or discontinue medication (BZD).\n\nThe focus is on the effect of combined care, but the implementation of this approach is also evaluated, which will provide valuable knowledge for further health developments in Primary Care.', 'armGroupLabels': ['Experimental']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Sending a "Benzocarta" to each person\'s postal address-a personalized letter signed by their Family Doctor, an explanatory sheet on how to gradually reduce medication, and infographics on sleep hygiene, stress, or anxiety.', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25126', 'city': 'Almenar', 'state': 'Lleida', 'country': 'Spain', 'facility': 'Primary Care Team of Alfarrà s-Almenar.', 'geoPoint': {'lat': 41.79604, 'lon': 0.56834}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Magi Claveria', 'class': 'OTHER'}, 'collaborators': [{'name': "Fundacio d'Atencio Primaria", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Magi Claveria', 'investigatorAffiliation': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}}}}