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

M

Magi Claveria

Status

Active, not recruiting

Conditions

Benzodiazepines Deprescribing

Treatments

Other: Control
Other: psycho-educational intervention and therapeutic activity

Study type

Interventional

Funder types

Other

Identifiers

NCT06950567
4R24/159

Details and patient eligibility

About

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.

Enrollment

113 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

113 participants in 2 patient groups

control
Sham Comparator group
Description:
Mailing a letter by postal mail
Treatment:
Other: Control
Experimental
Active Comparator group
Description:
Mailing a letter by postal mail along with psycho-educational intervention and therapeutic activity.
Treatment:
Other: psycho-educational intervention and therapeutic activity

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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