Evaluation of the Effectiveness of a Psychoeducational Intervention on Benzodiazepine Use in the Population Over 64 Years Old in Primary Care (BENZOS-AP)

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.

Study Overview

• Status: Completed
• Conditions: suspensión Completa Del Tratamiento Con Benzodicepinas; Disminución Del Consumo Benzodiacepinas
• Intervention / Treatment: Other: Control; Other: psycho-educational intervention and therapeutic activity

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Lleida
    • Almenar, Lleida, Spain, 25126
      • Primary Care Team of Alfarràs-Almenar.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥65 years.
• Current benzodiazepine use for ≥3 months.
• Ability to provide written informed consent.

Exclusion Criteria:

• Severe psychiatric disorder, dementia, or epilepsy.
• Enrollment in a home care program, institutionalization, or palliative care.
• Language barriers or mobility limitations preventing attendance at the primary care centre.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: control; Mailing a letter by postal mail	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.
Active Comparator: Experimental; Mailing a letter by postal mail along with psycho-educational intervention and therapeutic activity.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who completely discontinued benzodiazepine treatment	Complete discontinuation of prescribed benzodiazepine treatment, defined as the absence of benzodiazepine use at follow-up, regardless of the baseline dose. The outcome was assessed by comparing the proportion of participants who had completely discontinued treatment in the intervention and control groups.	6 and 18 months after the initial intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weekly benzodiazepine dose expressed as diazepam equivalents	Change from baseline in the prescribed weekly benzodiazepine dose, expressed as diazepam-equivalent milligrams per week, comparing the intervention and control groups. Among participants who did not completely discontinue treatment, the proportions achieving partial dose reduction or maintaining the same dose were also described.	6 and 18 months after the initial intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): October 15, 2025
• Study Completion (Actual): October 15, 2025

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Benzodiazepines; Primary Health Care; Patient Education; Deprescribing; Benzodiazepine Withdrawal; Long-term Benzodiazepine Use
• Other Study ID Numbers: 4R24/159

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available because the informed consent obtained from participants did not include consent for data sharing. The study involved a relatively small sample recruited from a limited number of primary care practices, which could increase the risk of participant re-identification despite data anonymization. Aggregate study results are reported in the study publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No