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

NCT ID: NCT06950567

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Benzodiazepines Deprescribing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The minimal intervention will consist of sending a "Benzoletter" to each participant's mailing address. This includes a personalized letter signed by their Family Doctor, an explanatory leaflet on how to gradually reduce benzodiazepine use, and infographics on sleep hygiene, stress, and anxiety.

Among the participants, 45 will form the control group, while 24 will be part of the intervention group, which will also receive psychoeducational sessions and therapeutic exercises.

The effectiveness of both interventions will be evaluated after six months.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control

Mailing a letter by postal mail

Group Type SHAM_COMPARATOR

Control

Intervention Type 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.

Experimental

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

Group Type ACTIVE_COMPARATOR

psycho-educational intervention and therapeutic activity

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacio d'Atencio Primaria

OTHER

Sponsor Role collaborator

Magi Claveria

OTHER

Sponsor Role lead

Responsible Party

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Magi Claveria

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Primary Care Team of Alfarràs-Almenar.

Almenar, Lleida, Spain

Site Status

Countries

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Spain

Other Identifiers

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4R24/159

Identifier Type: -

Identifier Source: org_study_id

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