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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified April 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02782091
First received: May 17, 2016
Last updated: May 20, 2016
Last verified: April 2016
  Purpose

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 (SAS) 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. A number of 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.

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.


Condition Intervention
Schizophrenia Behavioral: Multiple Errands Test (MET)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of an Ecological Assessment of Executive Function (Multiple Errands Test) in Patients With Schizophrenia : Study of Discriminant Validity

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Comparison of quantitative variable between score for MET and standard functional evaluation [ Time Frame: Inclusion visit ]

Estimated Enrollment: 120
Study Start Date: May 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Schizophrenia Patient Behavioral: Multiple Errands Test (MET)
1 hour assessment in an unknown district with 2 independent raters.
Other Name: Errands Test (Shallice and Burgess, 1991)
Experimental: Control Subject Behavioral: Multiple Errands Test (MET)
1 hour assessment in an unknown district with 2 independent raters.
Other Name: Errands Test (Shallice and Burgess, 1991)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02782091

Contacts
Contact: Gwenaelle DELOURME (0)1 49 81 34 60 ext +33 gwenaelle.delourme@aphp.fr
Contact: Ewa BULZACKA (0)1 49 81 34 60 ext +33 ewa.bulzacka@gmail.com

Locations
France
Henri Mondor Hospital Not yet recruiting
Creteil, France, 94010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Franck SCHURHOFF, Prof, MD. Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02782091     History of Changes
Other Study ID Numbers: P150701
Study First Received: May 17, 2016
Last Updated: May 20, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
MET
Prognosis
Cognition
Ecological
Executive function

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2017