Clinical trial NCT06950567: Evaluation of the Effectiveness of a Psychoeducational Intervention on Benzodiazepine Use in the Population Over 64 Years Old in Primary Care
Official title: Evaluation of the Effectiveness of a Psychoeducational Intervention on Benzodiazepine Use in the Population Over 64 Years Old in Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Benzodiazepines Deprescribing
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Fundacio d'Atencio Primaria
First posted: 2025-04-30
Enrollment: 113
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of participants who have stopped taking benzodiazepines and/or have reduced their consumption measured in mg/week.
timeFrame: From the start of the intervention to six months afterward.
Secondary outcomes:
Other outcomes:
Locations:
city: Almenar
country: Spain
facility: Primary Care Team of Alfarràs-Almenar.
state: Lleida
Study officials:
References: