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Completed

NCT Number: NCT06209827

Effectiveness of a Community Intervention in the Chronic Use of Benzodiazepines: (BENZOSTOPJUNTOS)

This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for Benzodiazepines withdrawal compared to standard care.

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Key information

Conditions

Inappropriate Prescribing Chemically-Induced Disorders Drug Misuse Mental Disorders Prescription Drug Misuse Prescription Drug Overuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ingrid Ferrer López

Seville, 41011, Spain

About this study

The excessive use of benzodiazepines (BZDs) presents significant health concerns and high healthcare costs, particularly in Spain, where usage rates are among the highest globally. In Andalusian, over a 10% of the population use BZDs long-term, prompting the need for safe and effective reduction strategies.

This study aimed to assess the effectiveness of a comprehensive, multicomponent intervention utilizing education and support for BZD withdrawal compared to standard care.

The intervention involved educational discussions, consultations with health professionals, and letters supported by multiple scientific societies.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • users of health centre's with more than 4 weeks of benzodiazepines use.
  • users of health centre's over 18 years of age.

Exclusion criteria

  • users of health centre's with mental disorder.
  • users of health centre's terminal.
  • users of health centre's with alcohol dependence.
  • users of health centre's with dementia.
  • users of health centre's who had intellectual disabilities.
  • users of health centre's unable to cooperate with the questionnaires.

Treatment and study plan

Intervention for reducing benzodiazepines long-term use.

Behavioral

Comprehensive, multicomponent intervention utilizing education and support for benzodiazepines.

Family doctor, nurse, community pharmacist and social workers: carried out informative discussion with the patient with by providing educational material. They informed patients about the advantages, disadvantages and alternatives to benzodiazepines including a descending benzodiazepines schedule to minimize withdrawal symptoms. It briefly explained the professionals' concerns about the continued use of benzodiazepines and offers possible solutions.

If the patient requested a withdrawal, he/she was referred to the doctor.

Primary outcomes

  1. Number of dispensing of benzodiazepines.

    Time frame: 3.5 years

    Number of dispensing of benzodiazepines, measured at the level of the participant.

Secondary outcomes

  1. Knowledge

    Time frame: 6 months

    Knowledge: Empower questionary, measured at the level of the participant.

  2. Life Quality

    Time frame: 6 months

    Quality of life:Functional Status Measurement Sheets by coop World Organisation of Family Doctors (COOP/ WONCA):

    The six COOP-WONCA Charts are described by vignettes and measured at the level of the participant: physical fitness, feelings, daily activities, social activities, change in health and overall health.

    WONCA: World Organisation of Family Doctors

Sponsors and collaborators

Lead sponsor

Andalusian Health Service

Other Gov

Collaborators

  • Andalusian School of Public Health

Registry information

Official study title

Effectiveness of a Multidisciplinary Intervention in the Reduction of Benzodiazepine Prescriptions: A Cluster Controlled Trial

Acronym: BENZOSTOP

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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