Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06275451 |
Other study ID # |
EssaiClinique_QUALI-RES |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 2024 |
Est. completion date |
January 2026 |
Study information
Verified date |
February 2024 |
Source |
University Hospital, Grenoble |
Contact |
Clément Dondé |
Phone |
04-76-76-39-86 |
Email |
cdondecoquelet[@]chu-grenoble.fr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Emotional regulation (ER) is conceptualised as a transdiagnostic process involved in the
development and maintenance of various mental disorders. Emotion regulation strategies have
traditionally been classified as maladaptive or adaptive. Adapted emotion regulation
strategies are thought to protect against psychopathology, whereas maladaptive strategies are
considered to be psychopathological risk factors.However, recent theoretical models indicate
that strategy choices need to be studied in relation to context and the notion of flexibility
in emotional regulation. The notion of flexibility in emotional regulation refers to the
individual's ability to use a repertoire of ER strategies to manage emotions according to
contextual demands.The role of emotional dysregulation in psychotic disorders has emerged as
a consubstantial feature of psychosis with important implications for its onset and
maintenance. Individuals suffering from a psychotic disorder or reporting psychotic-like
experiences (PLEs) have great difficulty regulating their emotions effectively. However,
knowledge about emotional regulation in psychosis has been predominantly quantitative,
neglecting patients' own perceptions.
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.
Secondary objectives:
1. To study the stages of emotional regulation in individuals suffering from schizophrenia
using a qualitative methodology (semi-structured interview) in line with theoretical
models in psychology.
2. To study the factors that appear to influence emotional regulation in individuals with
schizophrenia using a qualitative methodology (semi-structured interview) and,
therefore, from the person's point of view.
3. To study, from the person's point of view, what could be useful to improve emotional
regulation in individuals with schizophrenia using a qualitative methodology
(semi-structured interview).
This is a type 3 study under the Jardé law, multicentre, involving the human person. This
qualitative cross-sectional study includes patients diagnosed with schizophrenia from the
Centre Hospitalière Alpes Isère, the Centre Hospitalière Universitaire de Grenoble Alpes and
patients recruited via social networks. Its cross-sectional nature will enable us to collect
data using a semi-structured interview developed specifically to explore issues relating to
emotional regulation.
This study presents negligible risks or constraints for patients. The interview is designed
to respect patients' time and leave them free to talk about their difficulties with emotional
regulation as they wish. A large number of studies using qualitative methodology to address a
range of different subjects have already demonstrated the feasibility and adaptability of
these measures with patients with schizophrenia. However, these patients may find the
interview tiring. To mitigate this potential risk, the investigators decided to offer an
'on-demand' interview to the subjects of the study, i.e. they will be able to complete the
information form consecutively or in instalments and to take regular breaks during the
interview. The interviews will be conducted by a clinical psychologist with experience of
working with people with schizophrenia. Despite the possible minor risks (e.g. fatigue,
discomfort) associated with this research, the investigators hope that it will lead to a
better understanding of the factors involved in emotional regulation in patients with
schizophrenia. Ultimately, this knowledge could lead to the development of quantitative
studies to test the hypotheses that will emerge from this large-scale study and, potentially,
to psychological treatments aimed at improving emotional regulation in patients with
schizophrenia.
Description of the study process :
Selection visit: The selection visit will take place either during an appointment with the
investigator as part of the treatment, or remotely (Zoom platform). The selection visit will
be remote, particularly if the patient was recruited via social networks. For the latter, the
information note will be accessible in the announcement of the study before any contact is
made.
For participants followed up in the centres involved in this research, before the patient is
contacted, the presence of the inclusion criteria and the absence of the study's
non-inclusion criteria will be checked. For participants recruited online, during this visit
the investigator will check the inclusion and non-inclusion criteria without collecting this
information and/or noting it on the CRF.
The study will be presented to the patient, along with its risks and benefits, and an
information letter will be provided.
Inclusion visit and Visit 1: During the inclusion visit, which is carried out either
face-to-face at the next appointment with the investigator or remotely (Zoom platform),
depending on the patient's preferences, the investigator will put in place arrangements to
prove that the person who is to take part in the research has been informed. The investigator
will also ascertain that the patient does not object to taking part in the study. The
investigator will also record the patient's eligibility in the CRF.
Patients will then complete the semi-structured interview (see appendix) and fill in a
General Information Form, and the CRF will be completed.
Coding methodology :
The mean and standard deviation will be calculated for all scales. For categorical variables
(e.g. gender), the investigators will calculate the N and the percentage.
The data will be saved on the Université Grenoble Alpes server for the duration of the
research. They will then be deleted from the university server and saved on the CHUGA
servers.
The transcribed data will be read and re-read to ensure familiarity with the data. All
interviews will be coded by the psychologist who conducted the interview (Emma Rolland
Carlichi), but in line with recommendations, multiple coding of a number of interviews,
review of the coding framework by the team (Catherine Bortolon, Céline Baeyens and Clément
Dondé) and regular consultation with the team, including in the event of uncertainty during
coding, will aim to increase reliability.
Two preliminary transcripts will be examined in their entirety by two members of the research
team (Emma Rolland-Carlichi and Catherine Bortolon) who will each have independently recorded
ideas for possible codes before discussing them. The suggested codes will then be discussed
with a third member of the team (Céline Baeyens) who will also examine these initial
transcriptions. A preliminary coding framework, which will therefore incorporate multiple
perspectives on the data, will then be agreed. This framework will largely correspond to the
main themes of the interview guide, but it may evolve as ideas emerge throughout the
interviews.
The details of each code (including the specific data and coder behind the code, and whether
it was an a priori or 'in vivo' code) will be recorded using memos in Nvivo, to form a
codebook. The coding framework will be regularly reviewed by the research team and adjusted
accordingly.
As the coding framework evolves, previous interviews will be reviewed to ensure that
information relevant to emerging codes has been captured. Once all interviews have been
completed, 'coding checks' will be carried out for each transcript. This will involve the
lead coder reviewing their initial codes with 'fresh eyes' after a period of time, which has
been recommended as a strategy to mitigate the distorting effects that immersion in the data
can cause.
The interviews will be explored using inductive and deductive thematic analysis. As
indicated, this approach will be used to generate initial codes, which will be constantly
compared and modified as new interviews are added and analysed.
NvVivo will be used to facilitate the coding, organisation and analysis of the data.
Results:
The results of this project will initially increase our knowledge of ER in patients with
schizophrenia. They will enrich the scientific literature and the theoretical models of ER
applied to understanding the difficulties reported by clinical populations. In addition, the
use of a qualitative method will provide ecological information on the factors involved in
emotional regulation. Finally, the data obtained in this study will serve as a basis for the
development of quantitative studies enabling the ER to be assessed in a more appropriate way
on a large scale. Secondly, our results could guide the development of interventions
targeting the use of adaptive emotional regulation strategies in patients with schizophrenia.