NCT06263933

Brief Summary

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.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2025

Completed
Last Updated

February 16, 2024

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

January 3, 2024

Last Update Submit

February 14, 2024

Conditions

Keywords

retablishmentinsightmutual assistancepeer helperpsychiatric hospitalizationfirst psychotic episode

Outcome Measures

Primary Outcomes (1)

  • The level of the increasing of The INSIGHT scale

    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 Outcomes (2)

  • The increase of Recovery Scale

    At baseline (T0) and at 5 days after the intervention's beginning (T1).

  • The semi-structured interview

    At baseline (T0) and at 1 month after the hospitalization's end (T2).

Study Arms (2)

Control group

SHAM COMPARATOR

Patients are followed in routine care.

Other: Insight ScaleOther: Semi-directional interviewsOther: routine care

DIPEM group

EXPERIMENTAL

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 ScaleOther: Semi-directional interviewsOther: session of mutual assistance with a mediator psychologist

Interventions

Before the patient was in DIPEM or control group and after the patient is involved in DIPEM or control group

Also known as: stage of recovery scale
Control groupDIPEM group

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.

Control groupDIPEM group

routine care

Control group

session of mutual assistance with a mediator psychologist

DIPEM group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etablissement Public de Santé de Ville-Evrard

Neuilly-sur-Marne, 93330, France

RECRUITING

Related Publications (8)

  • Andresen R, Oades L, Caputi P. The experience of recovery from schizophrenia: towards an empirically validated stage model. Aust N Z J Psychiatry. 2003 Oct;37(5):586-94. doi: 10.1046/j.1440-1614.2003.01234.x.

    PMID: 14511087BACKGROUND
  • Courtet P. [Suicidal risk during the first psychotic episode]. Encephale. 2018 Dec;44(6S):S39-S43. doi: 10.1016/S0013-7006(19)30078-8. French.

    PMID: 30935486BACKGROUND
  • Fennig S, Kovasznay B, Rich C, Ram R, Pato C, Miller A, Rubinstein J, Carlson G, Schwartz JE, Phelan J, et al. Six-month stability of psychiatric diagnoses in first-admission patients with psychosis. Am J Psychiatry. 1994 Aug;151(8):1200-8. doi: 10.1176/ajp.151.8.1200.

    PMID: 8037256BACKGROUND
  • Franck N. [How to involve patients with schizophrenia in their treatment using psychoeducation]. Presse Med. 2016 Sep;45(9):742-8. doi: 10.1016/j.lpm.2016.07.012. Epub 2016 Aug 12. French.

    PMID: 27526987BACKGROUND
  • Kessler RC, Amminger GP, Aguilar-Gaxiola S, Alonso J, Lee S, Ustun TB. Age of onset of mental disorders: a review of recent literature. Curr Opin Psychiatry. 2007 Jul;20(4):359-64. doi: 10.1097/YCO.0b013e32816ebc8c.

    PMID: 17551351BACKGROUND
  • Malla A, McGorry P. Early Intervention in Psychosis in Young People: A Population and Public Health Perspective. Am J Public Health. 2019 Jun;109(S3):S181-S184. doi: 10.2105/AJPH.2019.305018.

    PMID: 31242015BACKGROUND
  • Souaiby L, Gaillard R, Krebs MO. [Duration of untreated psychosis: A state-of-the-art review and critical analysis]. Encephale. 2016 Aug;42(4):361-6. doi: 10.1016/j.encep.2015.09.007. Epub 2016 May 6. French.

    PMID: 27161262BACKGROUND
  • Thompson KN, McGorry PD, Harrigan SM. Reduced awareness of illness in first-episode psychosis. Compr Psychiatry. 2001 Nov-Dec;42(6):498-503. doi: 10.1053/comp.2001.27900.

    PMID: 11704943BACKGROUND

Central Study Contacts

Rusheenthira Thavaseelan

CONTACT

mathilde Pistre

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A control group and a intervention group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of research center and clinical professor

Study Record Dates

First Submitted

January 3, 2024

First Posted

February 16, 2024

Study Start

November 13, 2023

Primary Completion

November 13, 2024

Study Completion

November 13, 2025

Last Updated

February 16, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations