Completed

HAPEXIdentification and Validation of Addictology Expert Patients' Fields of Intervention With Inpatients for Addictive Disorders

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What is being tested

Expert patient in addictology

Behavioral
Who is being recruted

Behavior+4

+ Mental Disorders

+ Compulsive Behavior

From 18 to 99 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: June 2020
See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 19, 2020

Actual date on which the first participant was enrolled.

1. Targeted population : Major individuals hospitalized in the Department of Addictology and Psychiatry at Bichat Hospital. All participants sign a hospitalization contract upon arrival in which they undertake, among other things, to meet with the EP, within the framework of a system set up in the hospitalization unit since 2015. In order to be able to study the different factors influencing the intervention mechanism, it is decided to take the broadest possible selection criteria in order to remain representative of the heterogeneity of the target population. This is why the investigators have chosen to include all hospitalized patients in the service who agree to meet with an EP, at all socio-economic levels, for withdrawal from any substance regardless of the severity of the addictive disorder, regardless of the previous course of care with or without anxiety and depression symptoms 2. Inclusion criteria : Adults, hospitalized during the period of inclusion of the study in the addictology department at the Bichat-Claude Bernard Hospital in Paris, for withdrawal. Substance use disorder, diagnosed according to the criteria of the DSM-5, i.e. at least 2 diagnostic criteria. Patients who have received information about the research and signed the consent form. 3. Non inclusion criteria : Severe cognitive disorders, i.e. MoCA test < 11, Severe psychiatric disorders assessed using the MINI test (acute psychotic episode, manic or hypomanic episode, severe depression), No understanding of French, Patient under guardianship or curatorship, Patient refusal 4. Study conduct : STEP 1: Preliminary qualitative study * among the first eligible patients in the study to specify the content of EP's intervention, adapted to the inpatient's needs * Individual face-to-face interview, conducted by the principal investigator (PI) , according to the methodology socio-anthropological interviews * The interview will be conducted during the patient's hospitalization, whether the patient has already met with the EP or not. * Number of participants expected is not decided, the PI waiting for the saturation of information as it happens as the interviews progressed * A semi-structured interview grid will be followed * The interviews will be recorded and transcribed in the form of verbatim and then analyzed according to the content analysis technique * This analysis will be supervised by a socio- anthropologist from the research team of Robert Debré * The needs of patients will be produced by this analysis, and will be translated into fields of skills to be addressed during the EP's intervention * End of the study for these first participants STEP 2: Before and after comparative study on inpatients being their own witnesses. This is a study feasibility pilot * Eligible participants will be patients meeting the criteria for judgment and not having not participated in the first part of the study * They will be presented with the study and the collection of the consent at the beginning of hospitalization, before the EP's intervention * After agreement of participation, the initial socio-economic participants' characteristics will be collected on the variable collection notebook * Completion of the first competency assessment hetero-questionnaire before the EP's intervention (main criterion judgment evaluation). This questionnaire will have been constructed based on patient needs expressed in Part 1 * EP's Intervention, with patients hospitalized for withdrawal. These are weekly individual interviews, in room, proposed by the EPs to inpatients. * The second hetero-questionnaire will be proposed to the same patient during his hospitalization, within 48 hours of the EP's intervention (main criterion judgment evaluation) * A follow-up (by telephone or in person) will be carried out at 1 month and then 3 months to estimate the number of patients who have consumed during the hospitalization (frequency, quantity, duration) * End of the study for a patient 5. Inclusion : For the qualitative study, the investigators estimate that the data are saturated between 10 and 20 patients. For the quantitative study, the investigators estimate that there are 10 new patients per month. The investigators hope to include at least half of the target population, meaning 50 participants over the 10 months of the study. In total, for the entire study, an estimate of 70 participants. 6. Statistics analysis : The statistical analysis will be performed using SAS v9.3®. The quantitative variables will be presented as median, interquartile and missing data. The qualitative variables will be presented in terms of frequency, percentage and number of missing data. The initial characteristics of the patients will be presented. The indicators qualitative and quantitative acceptability will also be presented. The median of the results of the competency questionnaires between D0 and H48 will be compared between the group before and after by a Wilcoxon test (no hypothesis on the distribution of this variable). A multivariate analysis will be conducted to identify all the factors influencing the variation in questionnaire responses. This will allow the influence of patient profiles on outcomes to be taken into account.

Official TitleIdentification and Validation of Addictology Expert Patients' Fields of Intervention With Inpatients for Addictive Disorders
NCT04458987
Principal SponsorAssistance Publique - Hôpitaux de Paris
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

69 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior, AddictiveSubstance-Related DisordersChemically-Induced Disorders

Criteria

3 inclusion criteria required to participate
Patients hospitalized in the addictology department at the Bichat-Claude Bernard Hospital in Paris, for withdrawal.

Substance use disorder, diagnosed according to the criteria of the DSM-5, i.e. at least 2 diagnostic criteria.

Patients who have received information about the research and signed the consent form.

5 exclusion criteria prevent from participating
Severe cognitive impairment i.e. MoCA scale < or = 10

Severe psychiatric conditions assessed using the MINI scale : Acute psychotic episode, Manic or hypomaniacal episode, Severe depression

non comprehension of french

patient Under guardianship or curatorship

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
before/ after comparison, each patients being its own control

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Département psychiatrie et addictologie Bichat Claude Bernard

Paris, FranceOpen Département psychiatrie et addictologie Bichat Claude Bernard in Google Maps
CompletedOne Study Center
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