Impact of Case-management on Therapeutic Alliance With Fi... | NCT02873884

Studies
Impact of Case-management on Therapeutic Alliance With First Episode Psychosis Patients (CAMAT)

NCT02873884

Sponsor

University Hospital, Caen

Status

Unknown status

Last Update Posted

Apr 22, 2019Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Psychotic Disorders

Interventions

Case-management

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 2019

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

Nov 2016Actual

Primary Completion Date

Nov 2019Estimated

Completion Date

Nov 2019Estimated

First Submitted Date

Aug 17, 2016

First Submission Date that Met QC Criteria

Aug 19, 2016

First Posted Date

Aug 22, 2016Estimated

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 18, 2019

Last Update Posted Date

Apr 22, 2019Actual

Description Module

Brief Summary

The first aim of this study is to test the effect of the case management on the evolution of therapeutic alliance in patients with first episode psychosis in comparison with traditional nursing. The second aim is to test the effect of case management on nurses' well-being in comparison with traditional nursing. The third objective aims to show if therapeutic alliance is associated with insight in patients and with clinical and demographic data.

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

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
case-management		Patients will meet the case-manager 5 times per month during 1h30 in community living	Behavioral: Case-management
traditional nursing		Patients will meet the case-manager 2 times per month during 1h00 in hospital

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Case-management	Behavioral		case-management

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Work alliance inventory		6 months

Secondary Outcomes

Measure	Description	Time Frame
Birchwood insight scale		6 months
Scale to assess Unawareness of Mental Disorder		6 months
Well-being at work scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 16 and 30 years
First episode psychosis diagnosis according to DSM-5 criteria

Exclusion Criteria:

Lees of 16 years or more than 30 years
Not fulfilling DSM-5 criteria for first episode psychosis
Any treatment with the psychologist or the psychiatrist of the team

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

First episode psychosis patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laurent Lecardeur, PhD	Contact			lecardeur@cyceron.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Caen	Recruiting	Caen			France

Condition Browse Module

MeSH Terms

ID	Term
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019090	Case Management

Ancestor Terms

ID	Term
D010347	Patient Care Planning
D003191	Comprehensive Health Care
D010346	Patient Care Management
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided