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

April 25, 2025 updated by: Magi Claveria

The objective of this pragmatic, multicenter, randomized controlled clinical trial is to determine whether an educational intervention regarding benzodiazepine use can reduce the consumption and/or dosage of these drugs in individuals over 64 years old.

It aims to provide knowledge and skills to help participants tolerate or reduce discomfort, enabling them to begin decreasing or discontinuing benzodiazepine (BZD) use.

The focus is on the effect of combined care, but the implementation of this approach is also assessed, providing valuable insights for further health developments in Primary Care.

Researchers will compare a minimal intervention, consisting of sending a "Benzoletter" to each participant's mailing address, with an intensive intervention that additionally includes psychoeducational sessions and therapeutic exercises.

Participants in the intervention group will attend sessions at the Primary Care Center for a total duration of eight weeks.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • People over 64 years old who have been using benzodiazepines for a period of three months or more.
  • People with an active diagnosis of anxiety and/or insomnia.

Exclusion Criteria:

  • People with psychiatric comorbidities, dementia, epilepsy, included in the home care program (ATDOM), institutionalized, or in palliative care.
  • People with no possibility of contact or language barriers.
  • People with difficulty traveling to the Primary Care Center (CAP).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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
Time Frame
Number of participants who have stopped taking benzodiazepines and/or have reduced their consumption measured in mg/week.
Time Frame: From the start of the intervention to six months afterward.
From the start of the intervention to six months afterward.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Magi Claveria

Collaborators

Fundacio d'Atencio Primaria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 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)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 4R24/159

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Benzodiazepines Deprescribing

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe