Validation of a Tool for the Dimensional Assessment of Apathy in a Population Suffering From Schizophrenia. (HANDI-AS1)
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|ClinicalTrials.gov Identifier: NCT03801551|
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 18, 2019
Schizophrenia affects about 1% of the world's population. According to the WHO, it was one of the ten most worrying pathologies of the twenty-first century. The situation of psychic disability that results impacted the entire life course. This disease is characterized by positive symptoms (delirium, hallucination, psychotic agitation) and negative symptoms and disorganization (destructuring of thought, language and behavior). Cognitive disorders are easily measurable in the spectrum of schizophrenia and are quantifiable with some tools to measure the level of performance of the individual in different areas.
In these patients apathy is found in one out of two cases (prevalence of 51%), so it is a widespread negative symptom. Apathy corresponds to a pathology of voluntary action that can exist in different forms, resulting from the alteration of one or more mechanisms. It is a predictor of functional outcomes, regardless of positive symptoms or depression.
Studies of people with head injuries have found a link between frontal cognitive impairment and apathy. The recognition, the identification of the dimensional mechanisms of apathy and the understanding of the links with cognitive disorders are therefore a major issue in the improvement of the functional prognosis. Moreover, these mechanisms are currently little studied in the spectrum of schizophrenia.
There are currently questionnaires to show the presence or absence of apathy, such as the Apathy Evaluation Scale or the Lille Apathy Rating Scale. However most scales offer a global apathy score and the proposed treatments are limited due to the difficulty in identifying the dimensions and understanding of the underlying mechanisms of their own.
The potentiality of apathy to become a source of disability is now widely recognized. It is therefore important to consider the expression of this handicap in terms of the repercussions that this disorder may have on the daily lives of patients. There are questionnaires to measure the functional autonomy of patients with a psychic disorder. Apathy is also an obstacle to supporting patients in psychiatry.
The lack of knowledge and underestimation of apathy and its mechanisms in schizophrenia, in addition to overworking the psychiatric health sector, favor a drift towards the institutionalization of the person, with its medico-economic consequences on the system.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Diagnostic Test: Validate according to psychometric criteria, a dimensional measure of apathy in a population suffering from schizophrenia spectrum disorder and other psychotic disorders (according to DSM-5 criteria).||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of a Tool for the Dimensional Assessment of Apathy in a Population Suffering From Schizophrenia.|
|Actual Study Start Date :||July 3, 2018|
|Estimated Primary Completion Date :||August 4, 2020|
|Estimated Study Completion Date :||August 4, 2020|
Diagnostic Test: Validate according to psychometric criteria, a dimensional measure of apathy in a population suffering from schizophrenia spectrum disorder and other psychotic disorders (according to DSM-5 criteria).
Validate according to psychometric criteria, a dimensional measure of apathy in a population suffering from schizophrenia spectrum disorder and other psychotic disorders (according to DSM-5 criteria).
- validation of the scale [ Time Frame: 1 month ]The DAS is a self-rated multidimensional apathy measure, consisting of 24 items assessing Executive, Initiation and Emotional dimensions of apathy. Each item was rated on a 4-point Likert scale (Hardlyever, Occasionally, Often and Almost always), the minimum score for each subscale is 0 (least apathy) and the maximum 24 (most apathy), with a total score of 72. The French Dimensional Apathy Scale (f-DAS) was firstly tested on healthy participants. The Cronbach Alpha of f-DAS was 0.71 and reflected an acceptable internal reliability.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801551
|Contact: LISE M'BAREK||549 783 062 ext +firstname.lastname@example.org|
|Centre Hospitalier Esquirol||Not yet recruiting|
|Limoges, France, 87025|
|Contact: Emilie LEGROS-LAFARGE, Doctor|
|Centre Hospitalier de Niort||Recruiting|
|Niort, France, 79021|
|Contact: Lise M'BAREK 549 783 062 ext +33 email@example.com|
|Study Director:||LISE M'BAREK||Centre Hospitalier de Niort - France|