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

NCT06950567 | Active Not Recruiting

• 1 other identifier: 4R24/159
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benzodiazepines Deprescribing

Outcome Measures

Primary Outcomes (1)

• Number of participants who have stopped taking benzodiazepines and/or have reduced their consumption measured in mg/week.

  From the start of the intervention to six months afterward.

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:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Magi Claveria: 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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 30, 2025
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

ES (1)