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

Overview

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.

Long-term benzodiazepine use is common among older adults despite recommendations limiting treatment duration because of the increased risk of dependence, falls, cognitive impairment and other adverse effects. Although several interventions have been proposed to support benzodiazepine deprescribing, their implementation in routine primary care remains limited. This pragmatic, multicenter randomized controlled trial was designed to evaluate the effectiveness of a multidisciplinary intervention delivered in routine primary care. The intervention combined a minimal educational strategy consisting of a personalized letter from the participant's family physician ("Benzocarta") with an 8-week group-based psychoeducational program and supervised therapeutic exercise. The comparator group received the minimal educational intervention alone, reflecting usual clinical practice. The intervention was delivered by a multidisciplinary primary care team and focused on promoting benzodiazepine deprescribing through education, behavioural strategies and non-pharmacological management of insomnia, anxiety and stress. The study was conducted under real-world conditions in four primary care centres. Although the minimum required sample size was 69 participants, recruitment continued during the planned recruitment period because additional family physicians agreed to participate during the planned recruitment period. Consequently, the final enrolled sample exceeded the minimum target specified in the original protocol (122 participants). Follow-up assessments were performed at 6 and 18 months after the initial intervention to evaluate the long-term sustainability of benzodiazepine deprescribing and the occurrence of late relapse in benzodiazepine use. Protocol amendment: An additional follow-up assessment at 18 months after the initial intervention was incorporated before data analysis to evaluate the persistence of benzodiazepine discontinuation and potential late relapse. This amendment did not modify participant allocation, study interventions, or outcome definitions.