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Psychotic EpisodeDIPEMNCT06263933

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

A study testing Insight Scale, Semi-directional interviews and routine care in people with Psychotic Episode, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Psychotic Episode
What is being tested?
Insight Scale, Semi-directional interviews and routine care
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteFrance
Study dates
13 Nov 2023to 13 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Rusheenthira Thavaseelan contact

0143093232 ext. 033

r.thavaseelan@epsve.fr

mathilde Pistre contact

0143093232 ext. 033

m.pistre@epsve.fr

France1 site, 1 recruiting

  • Etablissement Public de Santé de Ville-Evrard

    Neuilly-sur-Marne, 93330

    Rusheenthira Thavaseelan, 0143093232 ext. 033, r.thavaseelan@epsve.fr

    Dominique Januel, 0143093232 ext. 033, d.januel@epsve.fr

    Recruiting

Other trials in France

About this study

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.

Being tested
Insight Scale, Semi-directional interviews, routine care, session of mutual assistance with a mediator psychologist
Keywords
retablishment, insight, mutual assistance, peer helper, psychiatric hospitalization, first psychotic episode

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insight ScaleOther

    Also called stage of recovery scale

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

  • Semi-directional interviewsOther

    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 careOther

    routine care

  • session of mutual assistance with a mediator psychologistOther

    session of mutual assistance with a mediator psychologist

Study groups in NCT06263933
Study groupRoleWhat they receive
Control groupSham comparatorPatients are followed in routine care.
Receives: Other: Insight Scale; Other: Semi-directional interviews; Other: routine care
DIPEM groupExperimentalPatients 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.
Receives: Other: Insight Scale; Other: Semi-directional interviews; Other: session of mutual assistance with a mediator psychologist

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (2)

  1. 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".

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2024
  2. Study start13 Nov 2023
  3. Primary completion13 Nov 2024 (estimated)
  4. Study completion13 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A control group and a intervention group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06263933
Sponsor's protocol ID
2023-A01804-41
Acronym
DIPEM
Status last verified
Dec 2023
First submitted
3 Jan 2024
Last updated
16 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 14511087

  • 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.

    PubMed 30935486

  • 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.

    PubMed 8037256

  • 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.

    PubMed 27526987

  • 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.

    PubMed 17551351

  • 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.

    PubMed 31242015

  • 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.

    PubMed 27161262

  • 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.

    PubMed 11704943

Questions about this trial

What is this clinical trial studying?

A study testing Insight Scale, Semi-directional interviews and routine care in people with Psychotic Episode, run by Centre hospitalier de Ville-Evrard, France at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rusheenthira Thavaseelan (0143093232 ext. 033, r.thavaseelan@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The level of the increasing of The INSIGHT scale (time frame: at baseline (T0) and at 5 days after the intervention's beginning (T1).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06263933, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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