Effect of Experience Sharing and Mutual Assistance on Insight and Recovery During the First Psychotic Episode (DIPEM)

February 14, 2024 updated by: Dominique JANUEL, Centre hospitalier de Ville-Evrard, France
Controlled, prospective, qualitative and quantitative trial. The goal of this trial is to evaluate the mutual assistance early intervention device efficacy and its impact on insight and personal recovery of participants living with a first psychotic episode. This intervention lasts 5 days with 1 session per day of 1 hour 30 minutes. Three evaluations, before the intervention, after intervention and 1 month after the hospitalization's end.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Neuilly-sur-Marne, France, 93330
        • Recruiting
        • Etablissement Public de Santé de Ville-Evrard
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dominique Januel, Pr
        • Sub-Investigator:
          • Ilona Arcomano, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Man or woman between 18 and 40 years old
  • First psychotic episode under the guidance of a doctor
  • Brief psycotic trouble (SM-V)
  • Presenting a first psychiatry hospitalization (all modalities hospitalizations combined)
  • Fluent in French language (read and written)
  • Patient affiliated to a social protection system or beneficiary of Medical Aid of State
  • Patient having signed informed consent for his participation in the protocol

Exclusion Criteria:

  • Patients whose clinical condition does not allow them to participate in research
  • Patients placed in isolation rooms during the intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group
Patients are followed in routine care.
Other: routine care
routine care
Other: Insight Scale
Before the patient was in DIPEM or control group and after the patient is involved in DIPEM or control group
Other Names:
  • stage of recovery scale
Other: Semi-directional interviews

In the end of the intervention. In the end of DIPEM Or in the end of control group.

This intervention will be held after one month of hospitalization.
Experimental: DIPEM group
Patients have 5 session of mutual assistance with a mediator psychologist, during five days, with 1 session per day. Each session lasts 1h30, with 45 min for atelier, 15 min for pause and 30 min about collective discussion.
Other: Insight Scale
Before the patient was in DIPEM or control group and after the patient is involved in DIPEM or control group
Other Names:
  • stage of recovery scale
Other: Semi-directional interviews

In the end of the intervention. In the end of DIPEM Or in the end of control group.

This intervention will be held after one month of hospitalization.

Other: session of mutual assistance with a mediator psychologist
session of mutual assistance with a mediator psychologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of the increasing of The INSIGHT scale
Time Frame: at baseline (T0) and at 5 days after the intervention's beginning (T1).

Used the "Echelle de conscience de trouble" - insight scale. There are 8 items, with 3 choices for each items : agree, disagree, unsure. The time is 5 minutes.

Maximum score = 12, very good Insight Minimum score= 0, No Insight 9 and more= good insight
at baseline (T0) and at 5 days after the intervention's beginning (T1).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The increase of Recovery Scale
Time Frame: At baseline (T0) and at 5 days after the intervention's beginning (T1).
Scale of recovery "Stage of recovery instrument" (STORI). The time is 25 minutes. There are 5 dimensions of recovery, with 10 groups of questions, with 50 items in total. There is 5 choices for each items, with "0" to "2" for "not at all true currently" and "3" to "5" is "completely true currently".
At baseline (T0) and at 5 days after the intervention's beginning (T1).
The semi-structured interview
Time Frame: At baseline (T0) and at 1 month after the hospitalization's end (T2).
For the first semi-structured interview, with 11 questions on 3 themes : the crisis course and the hospitalization, the role of peers during hospitalization and finally afterwards hospitalization. For the second semi-structured interview, there are 13 questions with 4 themes : the hospitalization living, psychosocial functioning, trouble awareness and management of symptoms.
At baseline (T0) and at 1 month after the hospitalization's end (T2).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de Ville-Evrard, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2023

Primary Completion (Estimated)

November 13, 2024

Study Completion (Estimated)

November 13, 2025

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A01804-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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