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

NCT06950567 | Completed

• 1 other identifier: 4R24/159
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Deprescribing; Benzodiazepines; Primary Health Care; Patient Education; Benzodiazepine Withdrawal; Long-term Benzodiazepine Use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in weekly benzodiazepine dose expressed as diazepam equivalents

  6 and 18 months after the initial intervention

Study Arms (2)

control

SHAM COMPARATOR

Mailing a letter by postal mail

Other: Control

Experimental

ACTIVE COMPARATOR

Mailing a letter by postal mail along with psycho-educational intervention and therapeutic activity.

Other: psycho-educational intervention and therapeutic activity

Interventions

psycho-educational intervention and therapeutic activity OTHER

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.

Experimental

Control OTHER

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.

control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Primary Care Team of Alfarràs-Almenar.

Almenar, Lleida, 25126, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Nurse in Family and Community Nursing

Model Details: This was a pragmatic, multicenter, parallel-group randomized controlled trial conducted in primary care. Eligible participants identified by family physicians were individually randomized in a 1:2 ratio (intervention:control). All participants received a minimal educational intervention ("Benzocarta"), consisting of a personalized letter signed by their family physician with information on the risks of long-term benzodiazepine use, gradual dose reduction, a tapering schedule, and advice on sleep hygiene and stress management. Participants in the intervention group additionally received an 8-week multidisciplinary psychoeducational program with supervised therapeutic exercise, whereas the control group received no further structured intervention. Outcomes were assessed at 6 and 18 months after the initial intervention.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 30, 2025
• Study Start: April 1, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)