NCT07379073

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Jun 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 23, 2026

Last Update Submit

January 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Compliance with recommended maximum duration of benzodiazepine prescriptions among new users

    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

Study Arms (2)

Experimental Group (trained on PsychoMG website)

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Training intervention on benzodiazepine prescribing without access to the PsychoMG website providing evidence-based clinical decision algorithms for anxiety and sleep disorder management.

Interventions

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

Experimental Group (trained on PsychoMG website)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 30, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Last Updated

January 30, 2026

Record last verified: 2026-01