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

January 23, 2026 updated by: MSPU de Pins-Justaret
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group (trained on PsychoMG website)
Training intervention on benzodiazepine prescribing with access to the PsychoMG website providing evidence-based clinical decision algorithms for anxiety and sleep disorder management.
Other: Training
Training intervention on benzodiazepine prescribing with access to the PsychoMG website providing evidence-based clinical decision algorithms for anxiety and sleep disorder management.
No Intervention: Control Group
Training intervention on benzodiazepine prescribing without access to the PsychoMG website providing evidence-based clinical decision algorithms for anxiety and sleep disorder management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MSPU de Pins-Justaret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Psycho-MG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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