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NCT Number: NCT07379073

Evaluation of a Clinical Support Website for the Management of Common Mental Health Conditions in Primary Care on Compliance With Benzodiazepine Prescribing Recommendations

This cluster-randomized study aims to evaluate the impact of a web-based clinical support tool on adherence to recommended maximum durations for benzodiazepine prescriptions among new users in primary care. General practitioners (GPs) participating in the study will have access to the website, which provides evidence-based algorithms for the management of common mental health conditions, including anxiety and sleep disorders. Prescription data and patient characteristics will be extracted from the French national health insurance database (DCIR). The primary outcome is the proportion of new benzodiazepine users whose prescriptions comply with recommended duration guidelines. Multilevel logistic regression models will assess the intervention effect, adjusting for patient- and GP-level factors.

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Key information

Conditions

Benzodiazepine Use

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being a general practitioner or a specialist in general medicine.
  • Practicing in the Occitanie region.
  • Working in private practice.
  • Being registered under Sector 1 fee agreements.
  • Providing informed consent to participate in the study.
  • Having computer equipment in the medical office, available during consultation (desktop, laptop, tablet, or smartphone) with internet access.

Exclusion criteria

  • Physicians who have been practicing for less than two years, as they are unlikely to have sufficient retrospective data on prescription reimbursements for their patients.

Treatment and study plan

Training

Other

Training intervention on benzodiazepine prescribing with access to the PsychoMG website providing evidence-based clinical decision algorithms for anxiety and sleep disorder management.

Primary outcomes

  1. Compliance with recommended maximum duration of benzodiazepine prescriptions among new users

    Time frame: 12 months

    Primary outcome measure: adherence to recommended prescription duration (yes/no) for benzodiazepines

    A patient is considered to have a prescription duration for benzodiazepines that is either adherent or non-adherent if they had no benzodiazepine exposure in the previous year and their duration of exposure during the first treatment episode:

    • is less than 12 weeks for anxiolytic benzodiazepines,
    • is less than 28 days for hypnotic benzodiazepines and related drugs, in accordance with current recommendations.

Sponsors and collaborators

Lead sponsor

MSPU de Pins-Justaret

Other

Registry information

Acronym: Psycho-MG

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

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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