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Study Protocol

Cognitive dysfunction and its relationship with psychopathology and quality of life in patients with schizophrenia: a protocol for a cross sectional study

[version 1; peer review: 1 approved with reservations]
PUBLISHED 03 May 2024
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

One central characteristic of schizophrenia is cognitive dysfunction, which typically has modest to severe effects on a variety of cognitive areas. Evidence suggests that cognitive impairment may occur far sooner than the clinical symptoms. The connection between cognitive deficiencies and functional outcome indicators has attracted increasing attention in recent years. Cognitive deficits are widely known to affect overall functioning, In India, few studies have been conducted to determine the profile of cognitive abnormalities in individuals in the chronic phase of schizophrenia as well as those in remission. Research from developing nations is crucial because schizophrenia prevalence in these nations is thought to be lower than that in industrialized nations. The aim of this study will be to assess the prevalence of cognitive dysfunction in individuals with schizophrenia and examine the relationship between cognitive dysfunction with psychopathology and quality of life in individuals with schizophrenia.

Protocol

This will be a cross sectional hospital-based study. After ethical clearance, all patients in the Psychiatry Department meeting the criteria of Schizophrenia, according to the ICD-10, will be part of the study. The expected number of participants is 228. All participants within the age group of 18 to 65 years who are clinically diagnosed to have schizophrenia using ICD-10 and who are able to give written informed consent will be included in the study. The patient’s sociodemographic data will be collected in Outpatient or inpatient basis and then the following questionnaires will be applied to them: i) Socio-demographic Proforma; ii) The Positive and Negative Syndrome Scale (PANSS); iii) The World Health Organization Quality of Life-BREF scale (WHOQOL-BREF); and iv) Addenbrooke’s cognitive examination III (ACE). Once the aforementioned questionnaires are completed, the prevalence of cognitive dysfunction in patients with schizophrenia will be assessed, and its relationship with psychopathology and quality of life will be studied.

Keywords

cognition, cognitive dysfunction, schizophrenia, pathophysiology, quality of life

Introduction

Cognitive dysfunction is considered a “central characteristic” of schizophrenia.1 Schizophrenia typically has a modest-to-severe effects on various cognitive areas. Evidence suggests that cognitive impairment may occur far sooner than the clinical symptoms.2,3 Patients have cognitive impairments throughout their lives, with evidence of cognitive abnormalities observable before the development of any symptoms during the prodromal phase, at the beginning of the first psychotic episode, and throughout the course of schizophrenia.4 A patient with cognitive impairment typically struggles with daily tasks, including paying attention, processing information quickly, retaining it and recalling it, responding quickly to information, using critical thought, and solving issues. Such limitations frequently impede the patient’s capacity to attain and maintain success in the workplace; they interfere with community participation and, more crucially, prevent participation in rehabilitation and therapeutic activities.5

Progressive decline over time has been associated with cognitive deficiencies.6,7 Cognitive deficiencies significantly influence how the illness progresses and how it turns out in the end. Although alertness is linked to the capacity to deal with social issues, cognitive abilities such as verbal memory are associated with social functioning.8 These cognitive deficiencies affect the quality of life, including employment performance, community involvement, social problem-solving, and the development of social skills.911

The connection between cognitive deficiencies and functional outcome indicators has attracted increasing attention in recent years. This has motivated others to look for therapeutic options to help cognitive impairments, particularly in the early stages of the illness, to minimize or limit functional disability, which is problematic in the treatment of schizophrenia.1215

Cognitive deficits are widely known to affect overall functioning,16,17 yet so far not many studies have been conducted analyzing individuals in the chronic phase of schizophrenia1822 as well as those in remission2325 to determine the profile of cognitive abnormalities in patients from India. Research from developing nations is crucial because schizophrenia prevalence in these nations is thought to be lower than that in industrialized nations.26 Compared to emerging nations such as India, the results have proven to be worse in wealthy countries.27 It is claimed that patients’ cognitive profiles, which are key indicators of how their sickness would turn out, are comparable across economies.28 However, the number of studies on this topic is still limited.

Rationale

The evaluation of cognitive functioning is crucial for understanding the neurobiological correlates of this complex illness, as well as for creating cutting-edge therapies and rehabilitation plans. While researching this issue, we would be able to evaluate cognitive impairment in people with schizophrenia and examine how it relates to psychopathology and quality of life.

Aim

To study cognitive dysfunction and its relationship with quality of life in patients with schizophrenia.

Objectives

  • 1. To assess the prevalence of cognitive dysfunction in patients with schizophrenia.

  • 2. To examine the relationship of cognitive dysfunction with psychopathology and quality of life in patients with schizophrenia.

Methods

Study design

We will perform a cross sectional hospital-based study.

Study population

Patients diagnosed with schizophrenia being treated in the inpatient and outpatient departments of Psychiatry, Acharya Vinoba Bhave Rural Hospital, Sawangi (M), Wardha-442001 will be taken as the study population. The type of sampling done will be convenience sampling.

The sample size will be calculated using the following formula:

n=Z1α/2σ2

Where n is the sample size to be calculated and Z1-α ̸2 is the level of significance at 5% i.e. at 95% confidence level that is 1.96. σ is the estimated standard deviation i.e. 7.88 and d is the estimation error i.e. 1.023.

d = estimation error = 1.023

taking n=Z1α/2σ2

the number of participants needed in the study (n) is calculated to be 228.

Data collection

After ethical committee clearance, all patients admitted to the Psychiatry Department of Acharya Vinoba Bhave Rural Hospital, Sawangi (M), Wardha-442001 who meet the criteria of Schizophrenia according to the International Classification of Diseases 10th Revision (ICD-10), will be included in the study. Informed consent of the patients will be obtained. The patient’s sociodemographic data will be collected using the sociodemographic proforma and then the following questionnaires will be administered i) Socio-demographic Proforma; ii) The Positive and Negative Syndrome Scale (PANSS) (copyright has been obtained); iii) The World Health Organization Quality of Life-BREF scale (WHOQOL-BREF) (copyright has been obtained); and iv) Addenbrooke’s cognitive examination III (ACE).

Ethics and consent

The Institutional Ethics Committee provided ethical approval for the study on 31/03/2023 (IEC no. – DMIHER (DU)/IEC/2023/873). Patients who are targeted for this study will be asked to provide written informed consent.

Inclusion criteria

  • 1. Patients who are clinically diagnosed with Schizophrenia using the ICD-10 criteria.

  • 2. Patients in the age group of 18 to 65 years.

  • 3. Patient should be fit to provide written informed consent. Firstly, the patient would be informed about the study and that the patient should be competent to make a decision. The patient should have the capacity to understand the purpose of the study that is being conducted, that it is their decision in participating in the study.

Exclusion criteria

  • 1. Subjects who are not willing to give written informed consent.

  • 2. Patients who are medically not fit or are not able to cooperate with the study.

  • 3. Patients with a history of delayed developmental milestone or any other major organic brain disease.

  • 4. Patients having a history of head injury.

Tools

  • 1. Socio-demographic data: This proforma is semi-structured and contains information regarding sociodemographic variables such as age, sex, marital status, education, religious background, occupation, and domicile background. The clinical data sheet contains variables such as age of onset, illness duration, precipitating factors, and treatment history, if available. The proforma was created by our team.

  • 2. PANSS: The PANSS includes 30 items, with a seven point rating scale.29 It was devised as an operationalized method that evaluates positive, negative, and other symptoms based on a formal semi-structured clinical interview. Of the 30 items, seven items are under a positive scale assessing features that are super added to a normal mental status, seven items are grouped into a negative scale that assesses features that are absent from a normal mental status, and the remaining 16 items contain a general psychopathology scale that measures the overall severity of schizophrenic disorder by summation of 16 items. It has an internal reliability ranging from 0.73 to 0.83.

  • 3. WHOQOL-BREF SCALE: This questionnaire has 26-items, with a five-point Likert scale that was developed by WHO to assess the quality of life over the past 2 weeks.30 Four domains are assessed here: physical health includes seven items, psychological health includes six items, social relationships includes three items, and environmental health includes eight items. Two items are also included for overall quality of life and general health. Each item on the scale has a rating from 1 to 5, where each domain score is added to obtain a raw score for each domain. A high rating on a scale implies a high quality of life. The WHOQOL-BREF domain scores demonstrate good divergent validity, content validity, internal consistency, and test-retest reliability.

  • 4. ACE III: Five cognitive domains tested in this screening exam: attention, memory, language, fluency, and visuospatial skills.31 It is useful for the detection of cognitive impairment and can differentiate between patients with and without cognitive impairment. It takes 20 minutes to complete. The total score is 100, with higher scores indicating stronger cognitive functioning.

Statistical analysis

SPSS version 28.0 software will be utilized to analyze descriptive statistics. Continuous variables will be presented as mean ± SD. Categorical variables will be expressed as frequencies and percentages. For the comparison of means, the Student’s t-test or Mann–Whitney U test will be used. If two categorical variables are associated, it will be determined using Pearson’s chi-square test or the chi-square test of association. Spearman/Pearson’s correlation will be used to compare cognitive dysfunction with psychopathology and quality of life in patients with schizophrenia. Statistical significance will be set at p value<0.05.

Expected outcomes

Through this study we will be able to assess the prevalence of cognitive disfunction in schizophrenia and learn about its relationship with negative and positive symptoms of schizophrenia and the quality of life of the patients living with schizophrenia who have cognitive dysfunction.

Ethical or other implications

  • 1. The confidentiality of every participant will be guaranteed, and written consent will be required before participating in this study. They will be notified that they can withdraw their consent at any time, after which they will be excluded from the study.

  • 2. The purpose of the study will be explained to the participants and samples will be selected on a voluntary basis.

Bias

A simple random sampling will be followed for the selection of the study participants to prevent selection bias. To avoid measurement bias, an open ended questionnaire will be used.

Dissemination

This study will be presented in the National Conference Proceedings and published in an indexed journal.

Study status

Participant recruitment has not yet begun.

Discussion

A meta-analysis conducted by Schaefer et al., in 2013 of 100 studies involving 9,048 patients with schizophrenia and 8,814 healthy controls found that there were significant generalized cognitive impairments in patients with schizophrenia, with moderate to severe impairments compared to controls across all neuropsychological measures examined and somewhat larger cognitive differences in the domains of processing speed and episodic memory.32

By applying the ACE-R SCALE i.e., Addenbrooke Cognitive Examination-Revised Scale, Talreja et al. (2013) evaluated individuals living with schizophrenia.33 It revealed that cognitive failure in the areas of attention, language, memory, focus, and executive function existed in 70% of the patients. Patients who lived in urban environments and had illnesses that lasted longer than two years had increased cognitive impairment. Masculine gender has been linked to impairment in language and memory.

Cross-sectional studies have demonstrated a link between negative symptoms and cognitive deficits in patients with schizophrenia. A link was studied between cognitive domains and four symptom dimensions (positive, negative, depressed, and disorganized) in a meta-analysis by Dominguez et al.34 The strongest correlations between negative symptoms and verbal fluency, verbal learning and memory, and IQ were discovered.

A total of 100 individuals suffering from chronic schizophrenia and 100 matched normal controls in a study titled “Cognitive impairment and associated factors in patients with chronic schizophrenia” were compared by Srinivasan et al. (2005)35 who found that patients with schizophrenia performed poorly on all cognitive tests when compared to controls without schizophrenia. Patient cognitive impairments were associated with sex, education level, age, disease duration, and the presence of both positive and negative symptoms.

Addington et al., examined the cognitive functioning of a patient population experiencing their first episode of schizophrenia with that of people who had previously had the illness. A total of 111 patients who experienced their first episode of schizophrenia and 76 outpatients with a history of illness were included in the study. The two categories did not substantially differ from one another with regard to cognitive performance. Although the patients from the first episode scored higher, their performance was subpar.36 They concluded that people who experienced their first episode exhibited cognitive abnormalities similar to those of patients who had been diagnosed with schizophrenia.

In 2020, a study on “cognitive dysfunction and impairment in persons living with schizophrenia” was conducted by Srisudha et al., with 82 adult individuals who had been diagnosed with schizophrenia.37 Overall, 93.9% had at least one mild cognitive symptom. Being married was linked to greater cognitive performance. Cognitive impairment was not linked to any other sociodemographic variable. Cognitive deficits and disability were substantially correlated, indicating that a greater cognitive deficiency in schizophrenia is associated with a greater risk of disability. They concluded that cognitive remediation treatments supported by scientific data should be part of schizophrenia treatment plans.

In their hospital-based study on “Disability among patients with schizophrenia” published in 2019, Fakorede et al., found that 78% of 300 patients had some form of impairment, 77% of which were mild to moderate, and 1% of whom had severe disability. They discovered that impairment is particularly common among patients with schizophrenia, and is linked to a more severe form of the condition.38

According to Harvey et al., several factors contribute to disability, such as negative symptoms, impairments in daily functioning and social skills, and cognitive and social cognitive impairments.39 These deficits are linked to many aspects of disability, and neither disability nor the factors that predict it have a single universal dimension.

According to a study by Tonmoy et al. (2003) cognitive impairment in patients with schizophrenia invariably affects the functional outcomes of the illness (i.e., a person’s capacity for social engagement, employment, and self-care).40

Limitations

  • 1. The study design is a cross sectional based study.

  • 2. Adults with other medical co-morbidities will not be included.

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Longkumer I and Patil R. Cognitive dysfunction and its relationship with psychopathology and quality of life in patients with schizophrenia: a protocol for a cross sectional study [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:442 (https://doi.org/10.12688/f1000research.143365.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
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Reviewer Report 12 Jun 2024
Cristina Delgado Sallent, Psychological and Brain Sciences, Boston University (Ringgold ID: 1846), Boston, Massachusetts, USA 
Approved with Reservations
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This paper aims to deepen the understanding of the prevalence of cognitive deficits and their relationship with the psychopathology of schizophrenia in India. The study adopts a cross-sectional design and intends to recruit 228 patients to perform four different assessments ... Continue reading
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Delgado Sallent C. Reviewer Report For: Cognitive dysfunction and its relationship with psychopathology and quality of life in patients with schizophrenia: a protocol for a cross sectional study [version 1; peer review: 1 approved with reservations]. F1000Research 2024, 13:442 (https://doi.org/10.5256/f1000research.157017.r279936)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

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Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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