New Relapse Model in Psychiatry (NRMP)

January 29, 2024 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Creation of a Visualization Tool With Integrated Clinical Data to Support Clinical Intervention and Empowerment of Inpatients in Psychiatry : Basis for the Development of a Predictive Model of Relapse

The goal of this clinical trial is to learn about risk factors of relapse in patients with alcohol use disorder. The main questions it aims to answer are :

  • Among patients with Alcohol Use Disorder, are there clusters of patients with the same characteristics and the same outcome ?
  • Which are the risk factors of relapse that are the most predictive ? Do they vary according to cluster?
  • Can a feedback-measurment-system (eg : a feedback of the tests' results) be usefull in a detoxification unit ?

Participants will :

  • Complete auto-questionnaires
  • Pass hetero-evaluations
  • Undergo an electrophysiological battery

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • To suffer from AUD
  • To be hospitalized
  • To speak French fluently
  • To be able to give their consent (medically and legally).

Exclusion Criteria:

  • To suffer from severe perceptive disabilities (auditory, visual)
  • To suffer from severe cognitive impairment

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Other: Auto-questionnaires, hetero-questionnaires and Evoked-potentials
Evaluations of risk factors of relapse by questionnaires, evaluation of evoked-potentials

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse or abstinence after detoxification
Time Frame: Throughout the entire study, approximately during 48 months
number of alcohol units and time to relapse or abstinence after detoxification
Throughout the entire study, approximately during 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction of the feedback-measurment-system for clinicians and patients
Time Frame: Throughout the entire study, approximately during 48 months
Simple questions with Likert-scale to evaluate the feedback-measurment-system
Throughout the entire study, approximately during 48 months

Collaborators and Investigators

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

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

Fonds National de la Recherche Scientifique

Investigators

  • Principal Investigator: Philippe de Timary, PhD, Université catholique de Louvain (Wallonia)

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)

February 1, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/09MAI/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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