NCT05737966

Brief Summary

Psychotic disorders are often chronic conditions that lead to impaired functioning, quality of life and social integration. Current research and recommendations for good practice are moving towards early detection and intervention. It is recognized that this leads to better adherence, alliance to care and knowledge of pathology for the patient, especially in young patients. For more than a decade, early intervention services (EIS) are opened in France over an increasingly large territory. Still too few studies assess the impact of these structures in France. These EIS offer a multimodal intervention (social, professional, psychotherapeutic). The intervention of case managers (or care coordinators in french) seems to be the core of EIS. The case manager has a fundamental role in the process of recovery in coordinating each individual's treatment and ensuring continuity of care. The PEPsy-CM study aims to evaluate the effectiveness on the relapse rate of a 3 year Program for Early Psychosis based on Case Management (PEPsy-CM) compared to TAU in a population of young people with a FEP. A qualitative evaluation of case management practice in EIS seems essential to assess the impact of case managers under real conditions. Based on the Australian Good Practice Recommendations (EPICC integrity tools) and the case management practice manuals, the PEPsy-CM check-list questionnaire was developed to evaluate the practice of case management in the EIS in France. This check-list contains different 35 items. The final score between 1(poor) to 5 (good) is established to determine the quality of the case management. Qualitative data are also collected during the interview with the participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

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

December 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

December 22, 2022

Last Update Submit

September 18, 2023

Conditions

Keywords

first episode of psychosis assertive community treatmentearly intervention in mental healthcase managementassertive community treatment

Outcome Measures

Primary Outcomes (7)

  • conformity to TIDieR checklist in each center and for each case manager interviewed

    TIDieR checklist Patient - Use of the case management manual (yes or no)

    1 year

  • conformity to TIDieR checklist in each center and for each case manager interviewed

    TIDieR checklist Patient - Use of specific and validated tools for Psychoeducation (yes or no)

    1 year

  • conformity to TIDieR checklist in each center and for each case manager interviewed

    TIDieR checklist Patient - Use of an information brochure on First Episode Psychosis (yes or no)

    1 year

  • conformity to TIDieR checklist in each center and for each case manager interviewed

    TIDieR checklist Patient - Use of specific and validated tools to support families (yes or no)

    1 year

  • conformity to TIDieR checklist in each center and for each case manager interviewed

    TIDieR checklist Patient - Use of specific and validated tools for Motivational Interviewing (yes or no)

    1 year

  • conformity to TIDieR checklist in each center and for each case manager interviewed

    TIDieR checklist Patient - Presence of Individualized Therapeutic Plan (ITP) supervision system (yes or no)

    1 year

  • conformity to TIDieR checklist in each center and for each case manager interviewed

    TIDieR checklist Patient - Use of Individualized Therapeutic Plan (ITP) supervision system (yes or no)

    1 year

Secondary Outcomes (2)

  • description of the global organisation of each center

    1 year

  • description of their involvement in the early intervention center

    1 year

Interventions

Evaluation of professional practices : evaluation of the case management carried out in a program for early psychosis in France using a checklist according good practices guidelines

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Professional working in an early intervention center treating first episodes of psychosis

You may qualify if:

  • Professional working in an early intervention center treating first episodes of psychosis
  • Professional involved in the organization/management of the center or practicing case management.

You may not qualify if:

  • Professional not working in the early intervention center
  • Professional working in the early intervention center but not having a role in the organization or management of the center or as case manager
  • Professional who does not take charge of people who have had a first psychotic episode

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schandrin

Nîmes, 30029, France

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

February 21, 2023

Study Start

February 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations