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Discriminant Validity of the Multiple Errands Test in Schizophrenia (VALITEM)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multiple Errands Test (MET)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Schizophrenia focused on measuring MET, Prognosis, Cognition, Ecological, Executive function

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Experimental group
  • Diagnosis of schizophrenia or schizoaffective disorder (DSM V criteria)
  • Clinically stable
  • Age : between18 and 50 years
  • Social security affiliation
  • French speakers
  • Written consent signed

Control group

  • Age : between18 and 50 years
  • Social security affiliation
  • French speakers
  • Written consent signed

Exclusion Criteria:

A history of neurological or somatic disorders with sensori-motor impact, a toxic or alcohol abuse in the 6 months prior to participation, an electroconvulsive therapy in the 12 months prior to participation, or any recent affective episode. Uncorrected perceptive disorders affecting the understanding of oral and written questions. Test district knowledge.

Sites / Locations

  • Henri Mondor Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Schizophrenia Patient

Control Subject

Arm Description

Outcomes

Primary Outcome Measures

Comparison of quantitative variable between score for MET and standard functional evaluation

Secondary Outcome Measures

Full Information

First Posted
May 17, 2016
Last Updated
March 29, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02782091
Brief Title
Discriminant Validity of the Multiple Errands Test in Schizophrenia
Acronym
VALITEM
Official Title
Validation of an Ecological Assessment of Executive Function (Multiple Errands Test) in Patients With Schizophrenia : Study of Discriminant Validity
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 16, 2016 (Actual)
Primary Completion Date
January 21, 2020 (Actual)
Study Completion Date
January 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 D'AUTO-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
MET, Prognosis, Cognition, Ecological, Executive function

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Schizophrenia Patient
Arm Type
Experimental
Arm Title
Control Subject
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Multiple Errands Test (MET)
Other Intervention Name(s)
Errands Test (Shallice and Burgess, 1991)
Intervention Description
1 hour assessment in an unknown district with 2 independent raters.
Primary Outcome Measure Information:
Title
Comparison of quantitative variable between score for MET and standard functional evaluation
Time Frame
Inclusion visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Experimental group Diagnosis of schizophrenia or schizoaffective disorder (DSM V criteria) Clinically stable Age : between18 and 50 years Social security affiliation French speakers Written consent signed Control group Age : between18 and 50 years Social security affiliation French speakers Written consent signed Exclusion Criteria: History of neurological or somatic disorders with sensori-motor impact Electroconvulsive therapy in the 6 months prior to participation Person living near the test site and/or knowing the neighborhood Person under guardianship Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck SCHURHOFF, Prof, MD.
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Discriminant Validity of the Multiple Errands Test in Schizophrenia

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