Gender Differences in Social Cognition in Patients With Schizophrenia of Recent Diagnosis and Healthy Controls Subjects
Individuals with schizophrenia have important and persistent deficits in multiple neurocognitive domains as well as in the Social Cognition (SC). SC refers to the mental operations underlying social behavior, and it is understood as a multidimensional construct that comprises emotional processing (EP), social perspective and knowledge, attributional bias and theory of mind (ToM) or mentalizing. Mentalizing and EP skills have been the two most studied subdomains of SC in schizophrenia. Both domains have been found to be impaired in chronic schizophrenia patients as well as in patients in early stages of the illness. In this context, although negative symptoms may play and important role, females seem to perform better than males in ToM and EP tasks, suggesting the presence of gender differences in the SC skills in patients with schizophrenia. However, to our knowledge, there are no studies that have explored the gender-related differences between cognitive and affective ToM and its relationship with the EP performance in schizophrenia patients of recent diagnosis comparing with healthy subjects.
In this line, the main objective of this project is to analyze the influence of gender in the cognitive and affective ToM abilities, in a group of patients with schizophrenia in early stages of the illness comparing with healthy subjects. Secondarily, this study pretends to explore the association between EP skills and affective ToM tasks performance in males and females with and without recent diagnosis of schizophrenia.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
50 patients (25 men and 25 women) will be recruited to participate in the study. Diagnosis of schizophrenia or schizoaffective disorder will be obtained through the medical records of each patient, and confirmed with the administration of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) (American Psychiatric Association, 1994) by an expert psychiatrist. The same professional will confirm the inclusion and exclusion criteria, and administrate and correct the Positive and Negative Syndrome Scale (PANNS) of all patients. An expert neuropsychologist will administrate and correct the the abbreviated form of the Wechsler Adult Intelligence Scale (WAIS-III) and the ToM and EP tasks.
In a second phase, a total of 50 healthy people (25 men and 25 women), matched according to age and years of schooling with the previous group, will be recruited. An expert neuropsychologist will confirm the inclusion and exclusion criteria, and administrate and correct the Vocabulary subtests of the WAIS-III and ToM and EP tasks.
All of them will be informed about the characteristics of the study before participating, and will sign an informed consent approved by the ethical committee of the hospital. The subjects will participate voluntarily.
4 groups ANOVAs will be performed for studying differences in affective and cognitive ToM between the groups (1-Women With Recent Diagnosis of Schizophrenia; 2-Men With Recent Diagnosis of Schizophrenia; 3-Healthy Women; 4-Healthy Men). Linear regression models will be performed for exploring the relationship between gender, negative symptoms (only in the schizophrenia sample) and EP (independents variables) in affective ToM (dependent variable).
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
-
-
Barcelona
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Sabadell, Barcelona, Испания, 08208
- Corporació Parc Tauli
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
PARTICIPANTS WITH SCHIZOPHRENIA
Inclusion Criteria:
- Patients meeting DSM-IV criteria for schizophrenia or schizoaffective disorder with less than 5 years of evolution of the disorder.
- Being an outpatient for at least 4 weeks before the study (clinical stability).
- No changes in the antipsychotic medication during the month before the study.
- Score less than 4 in the P1, P2 and P3 items of the PANSS.
- Score less than 4 in the Calgary Depression Scale.
Exclusion Criteria:
- Intellectual disability (IQ<70).
- History of brain damage.
- History of substance abuse (except nicotine or caffeine) during the last 12 months before the study.
PARTICIPANTS WITHOUT SCHIZOPHRENIA
Inclusion Criteria:
• Healthy people over 18 years old.
Exclusion Criteria:
- Sensory impairment: visual or hearing disabilities.
- Intellectual disability (IQ<70).
- History of neurologic disease.
- History of psychiatric disorder.
- History of substance abuse (except nicotine or caffeine) during the last 12 months before the study.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: Кейс-контроль
- Временные перспективы: Поперечный разрез
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Women schiz.
Women with recent diagnosis of schizophrenia
|
|
|
Men schiz.
Men with recent diagnosis of schizophrenia
|
|
|
Women healthy
Women without diagnosis of schizophrenia or other neurological and/or psychiatric diagnosis
|
|
|
Men healthy
Men without diagnosis of schizophrenia or other neurological and/or psychiatric diagnosis
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Affective Theory of Mind
Временное ограничение: Through study completion, an average of 6 months
|
Measured by: Reading the Mind in the Eyes test (RMET)
|
Through study completion, an average of 6 months
|
|
Cognitive Theory of Mind
Временное ограничение: Through study completion, an average of 6 months
|
Measured by: False belief stories
|
Through study completion, an average of 6 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Emotional Processing
Временное ограничение: Through study completion, an average of 6 months
|
Measured by: Pictures of Facial Affect (POFA)
|
Through study completion, an average of 6 months
|
|
Psychosis Symptoms
Временное ограничение: Through study completion, an average of 6 months
|
Measured by: Positive and Negative Syndrome Scale
|
Through study completion, an average of 6 months
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Intelligence Quotient (IQ) in schizophrenia groups
Временное ограничение: Through study completion, an average of 6 months
|
Measured by: The abbreviated form of the Wechsler Adult Intelligence Scale (WAIS-III) (Blyder et al., 2000)
|
Through study completion, an average of 6 months
|
|
Intelligence Quotient (IQ) in healthy groups
Временное ограничение: Through study completion, an average of 6 months
|
Measured by: The Vocabulary subtest (WAIS-III) in healthy participants.
|
Through study completion, an average of 6 months
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Sol Fernandez-Gonzalo, PhD, Corporació Parc Tauli
Публикации и полезные ссылки
Общие публикации
- Abu-Akel A, Bo S. Superior mentalizing abilities of female patients with schizophrenia. Psychiatry Res. 2013 Dec 30;210(3):794-9. doi: 10.1016/j.psychres.2013.09.013. Epub 2013 Oct 5.
- Bora E, Pantelis C. Theory of mind impairments in first-episode psychosis, individuals at ultra-high risk for psychosis and in first-degree relatives of schizophrenia: systematic review and meta-analysis. Schizophr Res. 2013 Mar;144(1-3):31-6. doi: 10.1016/j.schres.2012.12.013. Epub 2013 Jan 21.
- Bozikas VP, Andreou C. Longitudinal studies of cognition in first episode psychosis: a systematic review of the literature. Aust N Z J Psychiatry. 2011 Feb;45(2):93-108. doi: 10.3109/00048674.2010.541418.
- Green MF, Penn DL, Bentall R, Carpenter WT, Gaebel W, Gur RC, Kring AM, Park S, Silverstein SM, Heinssen R. Social cognition in schizophrenia: an NIMH workshop on definitions, assessment, and research opportunities. Schizophr Bull. 2008 Nov;34(6):1211-20. doi: 10.1093/schbul/sbm145. Epub 2008 Jan 8.
- Kohler CG, Turner TH, Bilker WB, Brensinger CM, Siegel SJ, Kanes SJ, Gur RE, Gur RC. Facial emotion recognition in schizophrenia: intensity effects and error pattern. Am J Psychiatry. 2003 Oct;160(10):1768-74. doi: 10.1176/appi.ajp.160.10.1768.
- Mesholam-Gately RI, Giuliano AJ, Goff KP, Faraone SV, Seidman LJ. Neurocognition in first-episode schizophrenia: a meta-analytic review. Neuropsychology. 2009 May;23(3):315-36. doi: 10.1037/a0014708.
- Savla GN, Vella L, Armstrong CC, Penn DL, Twamley EW. Deficits in domains of social cognition in schizophrenia: a meta-analysis of the empirical evidence. Schizophr Bull. 2013 Sep;39(5):979-92. doi: 10.1093/schbul/sbs080. Epub 2012 Sep 4.
- Navarra-Ventura G, Fernandez-Gonzalo S, Turon M, Pousa E, Palao D, Cardoner N, Jodar M. Gender Differences in Social Cognition: A Cross-Sectional Pilot Study of Recently Diagnosed Patients with Schizophrenia and Healthy Subjects. Can J Psychiatry. 2018 Aug;63(8):538-546. doi: 10.1177/0706743717746661. Epub 2017 Dec 7.
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2015534
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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