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Effectiveness of a Community Intervention in the Chronic Use of Benzodiazepines: (BENZOSTOPJUNTOS)

Effectiveness of a Multidisciplinary Intervention in the Reduction of Benzodiazepine Prescriptions: A Cluster Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06209827
Acronym
BENZOSTOP
Enrollment
472
Registered
2024-01-18
Start date
2018-01-01
Completion date
2021-12-31
Last updated
2024-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inappropriate Prescribing

Keywords

Benzodiazepine, Medication overuse., Inappropriate Prescribing

Brief summary

This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for Benzodiazepines withdrawal compared to standard care.

Detailed description

The excessive use of benzodiazepines (BZDs) presents significant health concerns and high healthcare costs, particularly in Spain, where usage rates are among the highest globally. In Andalusian, over a 10% of the population use BZDs long-term, prompting the need for safe and effective reduction strategies. This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for BZD withdrawal compared to standard care. The intervention involved educational discussions, consultations with health professionals, and letters supported by multiple scientific societies.

Interventions

BEHAVIORALIntervention for reducing benzodiazepines long-term use.

Comprehensive, multicomponent intervention utilizing education and support for benzodiazepines. Family doctor, nurse, community pharmacist and social workers: carried out informative discussion with the patient with by providing educational material. They informed patients about the advantages, disadvantages and alternatives to benzodiazepines including a descending benzodiazepines schedule to minimize withdrawal symptoms. It briefly explained the professionals' concerns about the continued use of benzodiazepines and offers possible solutions. If the patient requested a withdrawal, he/she was referred to the doctor.

Sponsors

Andalusian School of Public Health
CollaboratorOTHER_GOV
Andalusian Health Service
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Data collector was not involved in outcomes assessment.

Intervention model description

cluster-randomized, parallel-group trial in which health centres were the units of randomization and patients were the units of analysis

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* users of health centre's with more than 4 weeks of benzodiazepines use. * users of health centre's over 18 years of age.

Exclusion criteria

* users of health centre's with mental disorder. * users of health centre's terminal. * users of health centre's with alcohol dependence. * users of health centre's with dementia. * users of health centre's who had intellectual disabilities. * users of health centre's unable to cooperate with the questionnaires.

Design outcomes

Primary

MeasureTime frameDescription
Number of dispensing of benzodiazepines.3.5 yearsNumber of dispensing of benzodiazepines, measured at the level of the participant.

Secondary

MeasureTime frameDescription
Knowledge6 monthsKnowledge: Empower questionary, measured at the level of the participant.
Life Quality6 monthsQuality of life:Functional Status Measurement Sheets by coop World Organisation of Family Doctors (COOP/ WONCA): The six COOP-WONCA Charts are described by vignettes and measured at the level of the participant: physical fitness, feelings, daily activities, social activities, change in health and overall health. WONCA: World Organisation of Family Doctors

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026