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

NCT06950567 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-07-13

No results posted yet for this study

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.

Conditions

  • suspensión Completa Del Tratamiento Con Benzodicepinas
  • Disminución Del Consumo Benzodiacepinas

Interventions

OTHER

psycho-educational intervention and therapeutic activity

The objective is to provide knowledge and skills to tolerate/reduce discomfort so that they can begin to reduce or discontinue medication (BZD). The 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.

OTHER

Control

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.

Sponsors & Collaborators

  • Fundacio d'Atencio Primaria

    collaborator OTHER

  • Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2025-10-15
Completion
2025-10-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06950567 on ClinicalTrials.gov