Clinical Trial

Evaluation of the Effectiveness of a Psychoeducational Intervention on Benzodiazepine Use in the Population Over 64 Years Old in Primary Care

Study acronym: BENZOS-AP
Completed
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Summary
The goal of this pragmatic, multicenter, randomized controlled trial is to determine whether a multidisciplinary psychoeducational intervention combined with therapeutic exercise is more effective than a minimal educational intervention alone in helping older adults with long-term benzodiazepine use discontinue or reduce their medication. The main questions it aims to answer are: Does the multidisciplinary intervention increase the proportion of participants who completely discontinue benzodiazepine treatment? Does the intervention reduce the weekly benzodiazepine dose compared with the minimal intervention alone? Researchers compared a minimal educational intervention ("Benzocarta") with the same intervention plus an 8-week multidisciplinary psychoeducational program and supervised therapeutic exercise. Participants: received a personalized educational letter from their family physician explaining the risks of long-term benzodiazepine use and providing guidance for gradual dose reduction; were randomly assigned either to the control group (minimal intervention only) or to the intervention group (minimal intervention plus psychoeducational sessions and therapeutic exercise); were followed for 6 and 18 months after the initial intervention to assess benzodiazepine discontinuation and changes in weekly dose.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-25.
Status change: Active, Not Recruiting → Completed 2026-07-09
Trial Details
NCT Number NCT06950567
Lead Sponsor Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators: Fundacio d'Atencio Primaria
Conditions suspensión Completa Del Tratamiento Con Benzodicepinas, Disminución Del Consumo Benzodiacepinas
Enrollment 122 participants
Start Date 2024-04-01
Primary Completion 2025-10-15 (estimated)
Study Completion 2025-10-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-13