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

Psychotic Episode Clinical Trial

— DIPEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263933
• Other study ID #: 2023-A01804-41
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: November 13, 2025

Study information

• Verified date: December 2023
• Source: Centre hospitalier de Ville-Evrard, France
• Contact: Rusheenthira Thavaseelan
• Phone: 0143093232
• Email: r.thavaseelan[@]epsve.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 13, 2025
• Est. primary completion date: November 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Psychotic Episode

Intervention

Other:
• Insight Scale
Before the patient was in DIPEM or control group and after the patient is involved in DIPEM or control group
• 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.
• routine care
routine care
• session of mutual assistance with a mediator psychologist
session of mutual assistance with a mediator psychologist

Locations

Country	Name	City	State
France	Etablissement Public de Santé de Ville-Evrard	Neuilly-sur-Marne

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de Ville-Evrard, France

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The increase of Recovery Scale	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).
Secondary	The semi-structured interview	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).