NCT06275451

Brief Summary

The main aim of this study is to investigate emotional regulation in individuals with schizophrenia using a qualitative methodology (semi-structured interview) and, therefore, from the person's point of view. Given the qualitative nature of the methodology used in this study, the investigators have no specific hypothesis. The investigators have a general hypothesis suggesting that the patients' discourse will enable us to highlight the emotional regulation difficulties described in the literature.

Trial Health

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Trial Health Score

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Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

July 5, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

January 31, 2024

Last Update Submit

July 2, 2024

Conditions

SchizophreniaSchizophrenia Schizoaffective

Keywords

PsychosisQualitative study

Outcome Measures

Primary Outcomes (1)

  • Emotional regulation in schizophrenia

    Emotional regulation in schizophrenia The main objective of this study is to study emotional regulation in individuals suffering from schizophrenia using a qualitative methodology (semi-structured interview) and, therefore, from the person's point of view. Semi-structured interview; The patients' discourse and the themes emerging from this discourse in relation to emotional regulation.schizophrenia

    2 hours per participant / 2 years for research

Secondary Outcomes (3)

  • Factors influencing emotional regulation in schizophrenia

    2 hours per participant / 2 years for research

  • Improved emotional regulation in schizophrenia

    2 hours per participant / 2 years for research

  • Stages of emotional regulation in schizophrenia

    2 hours per participant / 2 years for research

Study Arms (1)

Semi-structured interview

Semi-structured interview

Other: Semi-structured interview

Interventions

Semi-structured interviewOTHER

Semi-structured interview on emotional regulation and administration of questionnaires lasting approximately 2 hours.

Semi-structured interview

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants will be drawn from a clinical population diagnosed with schizophrenia, aged between 18 and 60.

You may qualify if:

  • Schizophrenia or schizoaffective disorder verified using the criteria of the M.I.N.I. (Mini International Neuropsychiatric Interview) scale (First, Spitzer, Gibbon, Williams, \& others, 1995) based on the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) (Association \& others, 2013).
  • Patient in free care, under psychiatric care at the request of a third party or under curatorship. In the case of patients under curatorship, the investigator will inform the curator of the participant's non-opposition and therefore of his or her participation in the research.
  • Able to read, understand and speak French.
  • Age ≥ 18 years and \< 60 years
  • Must consent to the study and be able to give oral non-opposition.

You may not qualify if:

  • Psychological instability (i.e., Agitation or major suicidal risk on clinical examination by psychiatrist prior to study entry).
  • Neurological history/comorbidity (head injury, epilepsy, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Huntington's disease, stroke).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHUGA

La Tronche, 38700, France

RECRUITING

C3R

Saint-Martin-d'Hères, 38400, France

RECRUITING

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Clément Dondé

    University Grenoble, Hospital

    PRINCIPAL INVESTIGATOR

  • Catherine Bortolon

    C3R and UGA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clément Dondé

CONTACT

04-76-76-39-86cdondecoquelet@chu-grenoble.fr

Catherine Bortolon

CONTACT

04.76.82.58.26catherine.bortolon@univ-grenoble-alpes.fr

Study Design

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

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 23, 2024

Study Start

May 6, 2024

Primary Completion

May 1, 2025

Study Completion

January 1, 2026

Last Updated

July 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)