Ignite Creation Date:
2024-05-06 @ 8:38 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02782091
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2016-05-17
Brief Title:
Discriminant Validity of the Multiple Errands Test in Schizophrenia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Validation of an Ecological Assessment of Executive Function Multiple Errands Test in Patients With Schizophrenia Study of Discriminant Validity
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VALITEM
Brief Summary:
Schizophrenia SZ is a chronic severe disease resulting in a misperception of reality major social withdrawal and cognitive disturbances Executive dysfunctions are widely considered as primary determinants of functional outcome However classic neuropsychological executive function measures poorly represent patients functional outcome and seem inappropriate to evaluate the real-world functional impact of the disease
In this perspective Shallice and Burgess have developed for brain-damaged patients the Multiple Errands Test MET allowing to assess planning adaptation problem solving and mental flexibility in real life settings thus better capturing day-to-day abilities and including contextual social perceptive influences Setting the assessment outside the laboratory can help to identify subtle executive impairment not systematically expressed in standard care conditions and consequently improve the future care solutions MET is based on the Supervisory Attentional System model of executive functioning and attention control that specifies how thought and action schema become activated or suppressed for routine and non-routine circumstances
MET has been designed to measure real-world executive performance confronting the participants to unpredictable affordances and interpersonal interactions while planning and problem solving Patients are asked to accomplish several tasks of variable complexity in an unknown commercial district Severals rules must be respected and thus an action plan strategy formulation time and space management with very little assistance of the examiner are required
Most of the studies involving MET were conceived for patients with acquired brain damage LeThiec offered an extensive protocol with the initial scoring system in terms of inefficiencies rule breaks interpretation failures and task execution failures Simplified versions of MET were also suggested to be more suitable in hospital settings Only one study was done in SZ including a single patient it is therefore difficult to draw conclusions about clinical utility in SZ To date no other studies investigated the suitability of MET in patients with psychosis while executive impairment is well documented in this population The investigators hypothesized that the Multiple Errands Test MET an ecological assessment of executive function has a better ability to measure everyday adaptative functioning SZ compared to conventional EF assessment methods
In this perspective Shallice and Burgess have developed for brain-damaged patients the Multiple Errands Test MET allowing to assess planning adaptation problem solving and mental flexibility in real life settings thus better capturing day-to-day abilities and including contextual social perceptive influences Setting the assessment outside the laboratory can help to identify subtle executive impairment not systematically expressed in standard care conditions and consequently improve the future care solutions MET is based on the Supervisory Attentional System model of executive functioning and attention control that specifies how thought and action schema become activated or suppressed for routine and non-routine circumstances
MET has been designed to measure real-world executive performance confronting the participants to unpredictable affordances and interpersonal interactions while planning and problem solving Patients are asked to accomplish several tasks of variable complexity in an unknown commercial district Severals rules must be respected and thus an action plan strategy formulation time and space management with very little assistance of the examiner are required
Most of the studies involving MET were conceived for patients with acquired brain damage LeThiec offered an extensive protocol with the initial scoring system in terms of inefficiencies rule breaks interpretation failures and task execution failures Simplified versions of MET were also suggested to be more suitable in hospital settings Only one study was done in SZ including a single patient it is therefore difficult to draw conclusions about clinical utility in SZ To date no other studies investigated the suitability of MET in patients with psychosis while executive impairment is well documented in this population The investigators hypothesized that the Multiple Errands Test MET an ecological assessment of executive function has a better ability to measure everyday adaptative functioning SZ compared to conventional EF assessment methods
Detailed Description:
The objectives of this study are 1 establish normative data and 2 study discriminant validity of this tool with a large panel of EF measures
Methods
60 clinically stable SZ patients and 60 controls will be administered MET as well as two measures of executive function Wisconsin Card Sorting Test - 64 6 Elements Test Functional outcome will be assessed through Behavioural Inventory of Executive Functioning BRIEF-A ECHELLES LAUSANNOISES DAUTO-EVALUATION DES DIFFICULTES ET DES BESOINS ELADEB scale and Global Assessment of Functioning scale GAF scale Clinical measures will be recorded in patients Positive And Negative Symptoms Scale PANSS State Trait Anxiety Inventory - Y STAI-Y A Diagnostic Interview for Genetic Studies DIGS and Family Interview for Genetic Studies FIGS
Step1 The investigators will first compare patients and controls on all variables of MET and establish normative data
Step 2 The investigators will then study the discriminant validity of MET The investigators will compare MET with traditional measures of executive functioning The investigators will assess the correlation between each executive measure and functional outcome
Methods
60 clinically stable SZ patients and 60 controls will be administered MET as well as two measures of executive function Wisconsin Card Sorting Test - 64 6 Elements Test Functional outcome will be assessed through Behavioural Inventory of Executive Functioning BRIEF-A ECHELLES LAUSANNOISES DAUTO-EVALUATION DES DIFFICULTES ET DES BESOINS ELADEB scale and Global Assessment of Functioning scale GAF scale Clinical measures will be recorded in patients Positive And Negative Symptoms Scale PANSS State Trait Anxiety Inventory - Y STAI-Y A Diagnostic Interview for Genetic Studies DIGS and Family Interview for Genetic Studies FIGS
Step1 The investigators will first compare patients and controls on all variables of MET and establish normative data
Step 2 The investigators will then study the discriminant validity of MET The investigators will compare MET with traditional measures of executive functioning The investigators will assess the correlation between each executive measure and functional outcome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None