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\begin{document}

\title{Impact of Gaming Disorder on First Episode Psychosis Patients'
Evolution: Protocol for a Multicentered Prospective Study}



\author[1]{Maxime Huot-Lavoie}%
\author[2]{Charles Desmeules}%
\author[1]{Olivier Corbeil}%
\author[1]{Laurent Béchard}%
\author[1]{Sébastien Brodeur}%
\author[1]{Anne-Marie Essiambre}%
\author[1]{Chantale Thériault}%
\author[1]{Elizabeth Anderson}%
\author[1]{Lauryann Bachand}%
\author[2]{Zain Al-Aabideen Haider}%
\author[3]{Amal Abdel-Baki}%
\author[4]{Yasser Khazaal}%
\author[5]{Isabelle Giroux}%
\author[1]{Marie-France Demers}%
\author[1]{Marc-André Roy}%
\affil[1]{Centre de recherche CERVO}%
\affil[2]{Universite Laval Faculte de medecine}%
\affil[3]{Universite de Montreal Faculte de Medecine}%
\affil[4]{Lausanne University}%
\affil[5]{Universite Laval Ecole de psychologie}%


\vspace{-1em}



  
  \date{May 21, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Aims: The objective of this study is to underline the impact of Gaming
Disorder on the clinical evolution of patients with First Episode
Psychosis. The specific aims of the study are to determine the
prevalence of gaming disorder among those patients and assess the
consequences of gaming on their clinical trajectory. Methods: This is a
prospective multicenter cohort study that will enroll 800 patients
diagnosed with a first episode psychosis, with a follow-up period of up
to 3 years. Using a systematic screening procedure for gaming disorder,
the clinical staff will assess patients gaming habits at admission and
every 6 months thereafter. Information from patients' medical records
will also be extracted using the same timeframe. Results: The patients'
characteristics at admission and during follow-up will be presented in
the form of descriptive statistics and compared between different
subgroups of patients using uni- and multivariate logistic regression
models. Repeated measures ANCOVA will also be performed to analyze the
impact of gaming disorders on patients' clinical path as assessed by the
Positive and Negative Syndrome Scale and the Clinical Global Impression
scale, considering covariates such as psychiatric diagnosis,
pharmacological treatment, age, sex/gender, and duration of untreated
psychosis. Conclusion: These findings will guide the development of
prevention, detection, and treatment strategies for the comorbidity
between gaming disorder and first episode psychosis, ultimately
improving the patients' recovery.%
\end{abstract}%



\sloppy


\textbf{Impact of Gaming Disorder on First Episode Psychosis Patients'
Evolution: Protocol for a Multicentered Prospective Study}

Maxime Huot-Lavoie\textsuperscript{1-2}, Charles
Desmeules\textsuperscript{1-3}, Olivier Corbeil\textsuperscript{2,4-5},
Laurent B\selectlanguage{ngerman}échard\textsuperscript{2,4-5}, Sébastien
Brodeur\textsuperscript{1-2,5}, Anne-Marie
Essiambre\textsuperscript{2,6}, Chantale Thériault\textsuperscript{2},
Elizabeth Anderson\textsuperscript{2,6}, Lauryann
Bachand\textsuperscript{2,6}, Zain Al-Aabideen
Haider\textsuperscript{1}, Amal Abdel-Baki\textsuperscript{7-8}, Yasser
Khazaal\textsuperscript{9-10}, Isabelle Giroux\textsuperscript{6,11},
Marie-France Demers\textsuperscript{2,4-5}, Marc-André
Roy\textsuperscript{1-2,5}

\textsuperscript{1}Faculty of Medicine, Université
Laval,\textsuperscript{2}CERVO Brain Research Centre, Université
Laval,\textsuperscript{3}CHU de Québec-Université Laval Research Center
-- Université Laval, \textsuperscript{4}Faculty of Pharmacy, Université
Laval, \textsuperscript{5}Quebec Mental Health University Institute,
Centre intégré universitaire en santé et services sociaux de la capitale
nationale, \textsuperscript{6}School of Psychology, Université
Laval,\textsuperscript{7}Faculty of Medicine, Department of Psychiatry,
Université de Montréal, \textsuperscript{8}Montreal University Hospital
Research Center, \textsuperscript{9}Department of Psychiatry, Lausanne
University, \textsuperscript{10}Lausanne University Hospital Research
Center, \textsuperscript{11}Centre Québécois d'Excellence pour la
Prévention et le Traitement du Jeu

Corresponding author:

Maxime Huot-Lavoie, M.Sc.

Faculty of Medecine, Université Laval

1050, Av. de la Médecine

Quebec City (QC), Canada, G1V 0A6

Email:\emph{maxime.huot-lavoie.1@ulaval.ca}

Phone: (418) 694-2223

\section*{Abstract}

{\label{abstract}}

Aims: The objective of this study is to underline the impact of Gaming
Disorder on the clinical evolution of patients with First Episode
Psychosis. The specific aims of the study are to determine the
prevalence of gaming disorder among those patients and assess the
consequences of gaming on their clinical trajectory.

Methods: This is a prospective multicenter cohort study that will enroll
800 patients diagnosed with a first episode psychosis, with a follow-up
period of up to 3 years. Using a systematic screening procedure for
gaming disorder, the clinical staff will assess patients gaming habits
at admission and every 6 months thereafter. Information from patients'
medical records will also be extracted using the same timeframe.

Results: The patients' characteristics at admission and during follow-up
will be presented in the form of descriptive statistics and compared
between different subgroups of patients using uni- and multivariate
logistic regression models. Repeated measures ANCOVA will also be
performed to analyze the impact of gaming disorders on patients'
clinical path as assessed by the Positive and Negative Syndrome Scale
and the Clinical Global Impression scale, considering covariates such as
psychiatric diagnosis, pharmacological treatment, age, sex/gender, and
duration of untreated psychosis.

Conclusion: These findings will guide the development of prevention,
detection, and treatment strategies for the comorbidity between gaming
disorder and first episode psychosis, ultimately improving the patients'
recovery.

\section*{Background}

{\label{background}}

Psychotic disorders (PD), are major mental disorders that affect 3\% of
the population {[}1{]}. They occur during a critical period of life,
specifically in late adolescence and early adulthood {[}2{]}. Their
consequences include an increased rate of suicide and acts of
violence{[}3-5{]}, low employment rates {[}6{]}, reduced life expectancy
by 15 years {[}7, 8{]}, as well as homelessness and experiences of
stigmatization {[}9, 10{]}. In Canada, the economic burden of these
conditions was estimated to be \$7 billion in 2004 while the global
estimates indicate a range between 0.02\% and 1.65\% of the gross
domestic product in 2016 {[}11, 12{]}. While antipsychotic medications
are effective in alleviating certain symptoms, such as delusions and
hallucinations, they are not sufficient for achieving full recovery
{[}13{]}. In fact, PD are frequently associated with psychiatric
comorbidities, including substance use disorders, personality disorders,
and attention-deficit/hyperactivity disorder (ADHD), which can further
exacerbate the consequences associated with PD {[}14{]}. Therefore,
treating comorbidities is crucial for achieving recovery, particularly
in patients with first episode psychosis (FEP), where early intervention
has demonstrated the greatest impact on patients' long-term outcomes
{[}15{]}. Amongst other comorbidities, excessive video gaming has become
a cause for concerns for clinicians due to its impact on patients'
lives, in particular among young adults, but a literature review
conducted by our team {[}16{]} has highlighted a significant paucity of
data on video gaming comorbid with FEP, despite recent interest and
developments on this topic.

In recent decades, there has been a growing interest about the
consequences of excessive video gaming on mental health. This attention
has been prompted by the inclusion of Internet Gaming Disorder (IGD) as
a ``Condition for Further Study'' in the Diagnostic and Statistical
Manual of Mental Disorders, fifth edition (DMS-5), in 2013 {[}17{]}. The
recognition of this disorder as an official diagnosis in the 11th
edition of the International Classification of Diseases (ICD-11) under
the term Gaming Disorder (GD) has reinforced the importance and urgency
to better understand the clinical impacts of this condition {[}18{]}. GD
is defined as a persistent and recurrent pattern of gaming behavior,
involving digital or video gaming, characterized by an impaired control
over gaming as well as an increased priority placed on gaming over other
activities to the extent that it takes precedence over other interests
and daily activities. Individuals with GD continue or escalate their
gaming behavior despite experiencing negative consequences such as
reduced occupational or academic functioning {[}18{]}.

The reported prevalence of GD in the general population varies from
0.2\% to 20\% across studies {[}18{]}. This variability can be explained
by several factors, including the age of the participants studied, the
country where the study was conducted, or the definition of GD used in
the study. There are three main categories of risk factors associated
with GD: 1) those related to gaming and its practice (e.g. duration and
frequency of gaming, online and multiplayer games), 2) individual
factors (e.g. isolation, low self-esteem, impulsivity, difficulties in
emotion regulation, feelings of stigmatization, sex, gender, young age,
low education level), and 3) environmental factors (e.g. family
dysfunction, harassment and childhood neglect) {[}19, 20{]}. GD has also
been associated with other symptoms, mental disorders, and impairments
in functioning, such as depression, social anxiety, ADHD, impaired
academic performance, and deterioration in interpersonal relationships,
but a causal relationship has not been clearly established {[}21-30{]}.
In terms of treatment, promising results have been achieved with various
approaches, including cognitive-behavioral therapy. However, there is
currently insufficient data to draw solid conclusions regarding the
effectiveness of existing approaches {[}31{]}.

Regarding the comorbidity between GD and PD, the available literature is
limited to a few case reports describing the occurrence of brief
psychotic episodes following excessive video game use or abrupt
cessation {[}16{]}. Research on this comorbidity is therefore scarce and
lacks prospective data, which hinders the improvement of prevention,
detection, and treatment strategies. However, individuals with PD
present several common risk factors with GD: the male gender, social
isolation, low self-esteem, difficulties in emotion regulation,
impulsivity or behavioral inhibition, and onset of disorders during
adolescence or early adulthood {[}19, 20, 32-34{]}. Additionally, little
is known about the patterns of video game use among individuals with PD
(e.g. gaming time, game content, interface {[}console, mobile, computer,
online or offline{]}). For the affected youth, the consequences of GD
added to those of PD may further hinder recovery. Studying GD among
young adults with PD is then particularly relevant, as the risk factors
common to GD and PD are even more prevalent in this population compared
to the overall population with PD alone (e.g., substance use disorders,
male predominance, younger age) {[}35, 36{]}. Furthermore, it is well
established that clinical interventions in FEP significantly influence
clinical outcomes of affected individuals {[}15{]}.

In line with prevalent societal beliefs, video games have often been
associated with a negative perception that links them to aggressive and
criminal behavior {[}37{]}. However, an increasing body of evidence
suggests that video games can have beneficial effects and even serve as
a therapeutic tool. The term 'serious games' refers to software that
incorporates playful elements for educational, training, and therapeutic
purposes. Such games have been employed in the treatment of individuals
with PD, demonstrating a significant reduction in psychotic symptoms
{[}38, 39{]}. Additionally, they have shown improvements in cognitive
functions, social cognitions, and occupational status {[}40-43{]}.
Although the understanding of the impact of commercial video games on PD
is limited, a recent literature review highlights several advantages of
these types of games, with seven studies reporting positive outcomes
{[}44{]}. Among them, four studies revealed enhanced processing speed,
memory, and executive functions through the use of commercial video
games, while three studies demonstrated improvements in aerobic fitness
and walking speed in patients who engaged in active video games
utilizing the Kinect for Xbox game system {[}45-48{]}. These potential
benefits in individuals with PD underscore the unique nature of gaming
addiction, where the objective is to promote healthy gaming habits
rather than complete avoidance, as seen in other forms of addiction. In
order to help patients to reach these healthy habits, it is imperative
to enhance our comprehension of the influence of gaming on the clinical
trajectory of individuals diagnosed with PD.

Using an innovative screening and assessment procedure for GD tailored
to young adults with FEP, the aim of this study is to better understand
the impact of gaming in people with FEP by: 1) determining the
prevalence of GD among FEP patients; 2) determining the consequences of
GD on the clinical trajectory of FEP patients; and 3) assessing
individual factors that differentiate patients who developed GD among
the overall study population

\section*{Methods}

{\label{methods}}

\subsection*{Study design}

{\label{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.

\subsection*{Study settings}

{\label{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.

\subsection*{Participants}

{\label{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.

\subsection*{Variables}

{\label{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
the\emph{Internet 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 ``\emph{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 ``\emph{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 ``\emph{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.

\section*{Statistical analyses}

{\label{statistical-analyses}}

To meet the first two objectives, the patients' characteristics at
admission and during follow-up will be presented in the form of
descriptive statistics and compared between different subgroups of
patients using uni- and multivariate logistic regression models. All
tests will be performed with a bilateral significance level set at 5\%.

To meet the third objective, repeated measures ANCOVA will be performed.
In this analysis, the independent variable will be the presence or
absence of GD as defined by ICD-11 criteria, while the dependent
variables will be the clinical ratings (PANSS-6, CGI-S, SOFAS) measured
at admission and repeated every 6 months during the patients' follow-up.
The covariates of the analysis will be: 1) the main psychiatric
diagnosis; 2) the pharmacological treatment used; 3) the age and
sex/gender of the patients; 4) the duration of untreated psychosis;
these factors being determinant in the clinical evolution of the
patients living with FEP. The results from these analyses will be
performed with a bilateral significance level set at 5\%.

\section*{Discussion}

{\label{discussion}}

This aims to improve our understanding of the relationship between GD
and PD. It will be the first empirical study that explores this
comorbidity, which has only been previously discussed in a few case
reports. The results will not only confirm or refute the association
between GD and PD, but also provide a more detailed description of the
factors linking these two conditions and their consequences.

A notable strength of this study is the systematic screening procedure
of GD that has been developed, which eliminates any detection bias and
improves sensibility. All patients newly admitted to either of the two
participating FEP programs will undergo the same screening process,
irrespective of their disease progression and treatment history. This
systematic approach is particularly crucial given the limited knowledge
about the consequences of GD, which may be underestimated by both
patients and clinicians. On completion of the study, the screening
procedure for is expected to be implemented across all FEP programs in
Quebec, and potentially in other regions in Canada as well.

The study's large sample size and extended follow-up duration are also
significant strengths, ensuring sufficient statistical power to generate
meaningful findings. The lack of a consent requirement, combined with
the diverse areas served by the two participating FEP programs,
including urban and rural areas, ensures that the sample is
representative of the FEP population in Quebec. Consequently, the
findings are expected to be generalizable to all FEP programs in the
province.

By collecting variables that are routinely documented by clinicians as
part of their systematic clinical follow-up, the ecological validity of
this study is further strengthened. The close collaboration between our
research team and clinicians facilitates knowledge transfer and improves
the quality of patient care.

The primary limitation of this research project lies in its dependence
on clinician cooperation in adhering to the GD screening procedure, as
we have no control over their clinical practices and prescribing
patterns. However, we have implemented a monitoring committee to assess
clinicians' adherence to the GD screening process on a regular basis.
Furthermore, all new clinicians joining the study receive comprehensive
training in the utilization of this procedure. By considering these
methodological aspects collectively, we anticipate that the results will
substantially enhance our understanding of this understudied
comorbidity.

\subsection*{Abbreviations}

{\label{abbreviations}}

FEP: First-episode psychosis; GD: Gaming Disorder; DSM-5: Diagnostic and
Statistical Manual of Mental Disorders, Fifth Edition; ICD-11:
International Classification of Diseases, 11\textsuperscript{th}Edition;
PANSS: Positive and Negative Syndrome Scale; CGI: Clinical Global
Impression Scale; SOFAS: Social and Occupational Functioning Assessment
Scale; REDCap: Research Electronic Data Capture

\subsection*{Aknowledgements}

{\label{aknowledgements}}

The authors are thankful to the clinical staff working at the 2 study
sites for their precious collaboration and their unwavering dedication
to patients' recovery.

\subsection*{Authors contributions}

{\label{authors-contributions}}

MHL conceptualized the study, developed the screening and assessment
procedure for GD implemented it at both study sites, wrote the original
draft, reviewed, and edited the final draft. CD and OC wrote the
original draft, reviewed and edited the final draft. OC, LB, EF, SB,
AME, CD contributed to data collection, reviewed and edited the final
draft. CT managed the grant funding and coordinated research activity.
ZAAH and JR reviewed the final draft for accuracy, clarity, coherence.
AAB supervised the conduct of the study at site \#2. YK and IG provided
input in developing the screening and assessment procedure for GD,
critically reviewing and editing the original draft. MAR and MFD
supervised the conduct of the study at site \#1, supervised all stages
of the study, and critically reviewed and edited the original draft. MFD
coordinated responsibility for the grant funding. All authors reviewed
and approved the final draft.

\subsection*{Funding}

{\label{funding}}

This project is supported by a Mitacs Grant (IT34510). MHL is also
supported by the Frederick Banting and Charles Best Canada Graduate
Scholarship Doctoral Awards from the Canadian Institute of Health
Research (FID-172598). The funders played no role in this study, and we
have no restrictions regarding the submission of this protocol for
publication.

\subsection*{Data availability}

{\label{data-availability}}

Not applicable.

\section*{Declarations}

{\label{declarations}}

\subsection*{Ethics approval and consent to
participate}

{\label{ethics-approval-and-consent-to-participate}}

Ethics approval was obtained at both study sites (MP-13-2022-2470, NSM)
and the requirement to obtain consent was waived.

\subsection*{}

{\label{section}}

\subsection*{Consent for publication}

{\label{consent-for-publication}}

Not applicable.

\subsection*{Competing interest}

{\label{competing-interest}}

OC has received an honorarium from Janssen and Otsuka-Lundbeck Alliance.
MFD has received grants from Janssen and Otsuka-Lundbeck Alliance. MAR
has received grants from Otsuka-Lundbeck Alliance, Janssen, Sunovion and
Mylan. All other authors have no conflicts of interest that are directly
relevant to this study.

\subsection*{Authors details}

{\label{authors-details}}

\textsuperscript{1}Faculty of Medicine, Department of Psychiatry,

\textsuperscript{2}CERVO Brain Research Centre,

\textsuperscript{3}CHU de Québec-Université Laval Research Center --
Université Laval,

\textsuperscript{4}Faculty of Pharmacy, Université Laval,

\textsuperscript{5}Quebec Mental Health University Institute, Centre
intégré universitaire en santé et services sociaux de la capitale
nationale,

\textsuperscript{6}School of Psychology, Université Laval,

\textsuperscript{7}Faculty of Medicine, Department of Psychiatry,
Université de Montréal,

\textsuperscript{8}University of Montreal Hospital Research Center,

\textsuperscript{9}Department of Psychiatry, Lausanne University,

\textsuperscript{10}Lausanne University Hospital Research Center,

\textsuperscript{11}Centre Québécois d'Excellence pour la Prévention et
le Traitement du Jeu, Université Laval

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