Psychological Impact of Confinement on the Adult | NCT04353570

Studies
Psychological Impact of Confinement on the Adult

NCT04353570

Sponsor

Centre hospitalier de Ville-Evrard, France

Status

Unknown status

Last Update Posted

Apr 20, 2020Actual

Enrollment

2,100Estimated

Phase

Not provided

Conditions

Identify the Psychological Impact of Containment

Interventions

clinical interview

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Actual

Primary Completion Date

Jun 18, 2020Estimated

Completion Date

Jul 30, 2020Estimated

First Submitted Date

Apr 16, 2020

First Submission Date that Met QC Criteria

Apr 17, 2020

First Posted Date

Apr 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2020

Last Update Posted Date

Apr 20, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Januel, clinical research unit director, Centre hospitalier de Ville-Evrard, FrancePrincipal Investigator

Lead Sponsor

Centre hospitalier de Ville-Evrard, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This clinical interview is made to allow a clinical follow-up of the patients followed in psychiatry of the EPS Ville-Evrard establishment in a simple way and in a secure medical framework during the period of the epidemic and the confinement from March 30 to June 30, 2020.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clinical interview	Other	This interview can be carried out face to face or remotely. In the latter case, it is part of telemedicine, which is recognised by the health authorities in France.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Depression MINI DIAG and Anxiety questionnaire and the The Global Performance Rating Scale and CGI-truth		three month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient followed in outpatient psychiatry at EPS Ville Evrard and agrees to participate -

Exclusion Criteria:

Adult patient followed in outpatient psychiatry at EPS Ville Evrard and does not wish to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Adult patient followed in outpatient psychiatry at EPS Ville Evrard

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Youcef BENCHERIF	Contact	0782723674		youcef.bencherif@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unité de recherche clinique	Recruiting	Neuilly-sur-Marne	Île-de-France Region	93330	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided