NCT02873884

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

August 17, 2016

Last Update Submit

April 18, 2019

Conditions

Psychotic Disorders

Outcome Measures

Primary Outcomes (1)

  • Work alliance inventory

    6 months

Secondary Outcomes (3)

  • Birchwood insight scale

    6 months

  • Scale to assess Unawareness of Mental Disorder

    6 months

  • Well-being at work scale

    6 months

Study Arms (2)

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

Case-managementBEHAVIORAL
case-management

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

First episode psychosis patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Caen

Caen, France

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Case Management

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient Care PlanningComprehensive Health CarePatient Care ManagementHealth Services Administration

Central Study Contacts

Laurent Lecardeur, PhD

CONTACT

lecardeur@cyceron.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations

FR(1)