Methods
Study design
This is a prospective multicenter cohort study, akin to our previous
work [49], aiming to enroll a total of 800 patients who have been
diagnosed with FEP and with follow-up periods of up to 3 years. The
recruitment process began on November 1st, 2019, and will extend until
November 1st, 2023. Throughout this period, all individuals admitted at
the two designated sites will undergo comprehensive GD assessments by
clinicians upon admission and subsequently every 6 months, using a
specialized screening procedure developed exclusively for this study.
During this follow-up period, that will conclude on May 1st 2024, the
research team will extract independent variables from the patients’
medical records.
Study settings
This study is being conducted within 2 specialized programs for
individuals experiencing FEP in the province of Quebec, Canada. These
programs, which operate at multidisciplinary clinics, admit annually
approximately 200 patients presenting a FEP. The patients are
accompanied for up to 3 years on a case management approach that
involves close collaboration between a psychiatrist and a designated
case manager, who assumes the responsibility of overseeing and
coordinating the patient’s care and services, and could include either
psychologist, social works, occupational therapists, nurses and
specialized educators.
Patients are also offered family intervention, individual psychotherapy
and community outreach services during their follow-up period. The case
managers offer an extensive systematic clinical follow-up, employing
standardized questionnaires and involving input from the patients’
family members. All relevant clinical data derived from these activities
are extensively documented in the patients’ medical records. No consent
to participate in the study is required given the lack of any contact
between the patients and the research staff.
Participants
During the recruitment period, all patients admitted at the two study
sites will be included in the study. Clinic admission prerequisites
necessitate individuals to be within the age range of 18 to 35 years,
hold a primary diagnosis of FEP according to DSM-5 criteria
(encompassing both affective and nonaffective psychoses, along with
substance-induced psychotic disorder), and exhibit limited exposure to
continuous antipsychotic treatment (i.e., six months or less). The only
exclusions criteria are related to admittance criteria in the clinics,
specifically, organic psychosis and moderate/severe intellectual
disability.
Variables
The primary outcome is the prevalence of a GD diagnosis based on ICD-11
criteria established by the treating psychiatrist. As mentioned earlier,
the evaluation of this outcome is conducted by the case managers and
treating psychiatrists utilizing a specialized GD screening procedure
designed explicitly for this study in collaboration with experts in GD
and FEP. It is a 3-step procedure that includes: 1) a questionnaire for
assessing video gaming habits (frequence and duration of gaming session)
, 2) an evaluation of the severity of the gaming habits using theInternet Gaming Disorder Scale – Short Form (IGDS9-SF)[50] ,
and 3) a diagnostic interview assessing the ICD-11 gaming addiction
diagnosis criteria. The patients’ case managers conduct the initial two
steps, while the treating psychiatrist oversees the final step. The
results of this procedure are documented in the patients’ medical
records and subsequently extracted by the research staff. Variables that
are related to the clinical manifestations of the FEP are documented
using three standardized scales rated by treating psychiatrists every 6
months as part of the patients’ systematic follow-up. These variables
are recorded in the patients’ medical files and extracted by the
research staff. The severity of psychotic symptoms is measured using the
“Positive and Negative Syndrome Scale ” (PANSS), which is a
routinely used measure that allows clinicians to monitor the progression
of symptoms in patients with psychotic disorders [51]. The PANSS-6,
a shortened version that has excellent convergent validity with the
original PANSS, will be used in this study [52]. The severity of the
FEP will also be assessed using the “Clinical Global Impression
– Severity ” (CGI-S) scale, which quantifies the clinical presentation
of the disease using simple score ranging between 0 and 7[53, 54].
CGI-S scores have good correlation with PANSS scores [55]. Finally,
the individual’s functioning level will be evaluated using the
“Social and Occupational Functioning Assessment Scale ” (SOFAS),
a graded 0-100 scale quantifying patients’ social and occupational
functioning [56].
The research staff will extract various independent variables from the
patients’ medical records, encompassing socio-demographic factors (such
as sex at birth, gender identity, ethnicity, employment status,
education level, relationship status, living arrangements, and criminal
history) and other clinical variables (including the primary DSM-5
psychiatric diagnosis, comorbid DSM-5 psychiatric diagnoses, psychiatric
hospitalizations, community treatment order, and medication treatment,
which comprises antipsychotics and other psychotropic drugs like
antidepressants, benzodiazepines, hypnotics, mood stabilizers, and
psychostimulants). Regarding medication information, both current
(during the follow-up period) and past (prior to admission in the
clinics) medication details will be collected, encompassing dosages,
frequency, and route of administration. A patient will be considered
exposed to a medication after receiving it for more than one month (or
one injection in the case of long-acting injectable antipsychotics).
Medications administered on an as-needed basis will not be included in
the analysis.