NCT04458987

Brief Summary

Although there are many publications concerning the benefit of the interventions of the self-help movements and peer health mediators in psychiatry, no studies have described the intervention specific to patients with expertise in addictology (EP), nor evaluated their effectiveness. The objective of this study is twofold: identify and define the fields of intervention of EPs adapted to the specific needs of addictology patients. And validate, through a pilot study, the intermediate effectiveness of EP intervention. This EP intervention will be built on the areas of expertise defined in the first step. Intermediate effectiveness will be measured by patients' ability to manage their addiction. The first part of the study will consist of a preliminary qualitative patient-centered study to clarify patients' needs and expectations regarding the content of the EPs' intervention into a one addictology service of the university hospital of Bichat, Paris, France. This will make it possible to translate these needs into fields of expertise to address during the EPs' intervention and will result in the creation of a hetero-questionnaire. The second part of the study will consist of a before-and-after comparative study on inpatients who are their own controls based on the hetero-questionnaire constructed through the qualitative study. This study will identify the main EP's intervention fields in addictology in which EP are more relevant to patients. Thus, their inpatient interventions can be validated and improved, and better carried by addiction professionals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

June 19, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2021

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

January 27, 2020

Last Update Submit

October 15, 2021

Conditions

Keywords

expert patientsaddictologywithdrawaladdiction

Outcome Measures

Primary Outcomes (1)

  • median of the difference of the score of the competency questionnaires between D0 and H48 will be compared between the group before and the group after

    This EP intervention will be built on the areas of expertise defined in the first step. Intermediate effectiveness will be measured by patients' ability to manage their addiction. This will be measured by a hetero-questionnaire, created by the first part of the study, evaluating the skills acquired by patients before and after this intervention. As this is a new scale created thanks to the forst part of the study, the investigators don't know what will be the minimum, the maximum or/and the relation between the score and the outcome

    48 hours

Study Arms (1)

Expert patient in addictology

EXPERIMENTAL

before/ after comparison, each patients being its own control

Behavioral: Expert patient in addictology

Interventions

EP's Intervention, with patients hospitalized for addiction withdrawal. These are weekly individual interviews, in room, proposed by the EPs to inpatients. The content of the intervention will be defined trough the results of step one of the study.

Expert patient in addictology

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département psychiatrie et addictologie Bichat Claude Bernard

Paris, 75018, France

Location

MeSH Terms

Conditions

Substance-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Chanaëlle OBADIA, MD

    APHP

    PRINCIPAL INVESTIGATOR
  • Aurélie BOURMAUD, PhD

    APHP

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: patients hospitalized for addiction withdrawal in the addiction service of the university hospital Bichat, Paris, France
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

July 7, 2020

Study Start

June 19, 2020

Primary Completion

May 19, 2021

Study Completion

May 19, 2021

Last Updated

October 18, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations