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SchizophreniaVALITEMNCT02782091

Discriminant Validity of the Multiple Errands Test in Schizophrenia

A study testing Multiple Errands Test (MET) in people with Schizophrenia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia
What is being tested?
Multiple Errands Test (MET)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteFrance
Study dates
16 Jun 2016to 21 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Experimental group
  • Diagnosis of schizophrenia or schizoaffective disorder (DSM V criteria)
  • Clinically stable
  • Age : between18 and 50 years
  • Social security affiliation
  • French speakers
Show all 12Show fewer
  • Written consent signed
  • Control group
  • Age : between18 and 50 years
  • Social security affiliation
  • French speakers
  • Written consent signed

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Henri Mondor Hospital

    Créteil, 94010

Other trials in France

About this study

Official title: Validation of an Ecological Assessment of Executive Function (Multiple Errands Test) in Patients With Schizophrenia : Study of Discriminant Validity

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.

Read more

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.

Read the 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.

Conditions
Schizophrenia
Being tested
Multiple Errands Test (MET)
Keywords
MET, Prognosis, Cognition, Ecological, Executive function
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multiple Errands Test (MET)Behavioural

    Also called Errands Test (Shallice and Burgess, 1991)

    1 hour assessment in an unknown district with 2 independent raters.

Study groups in NCT02782091
Study groupRoleWhat they receive
Schizophrenia PatientExperimentalNot described
Receives: Behavioral: Multiple Errands Test (MET)
Control SubjectExperimentalNot described
Receives: Behavioral: Multiple Errands Test (MET)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Inclusion visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2016 (estimated)
  2. Study start16 Jun 2016
  3. Primary completion21 Jan 2020
  4. Study completion21 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02782091
Sponsor's protocol ID
P150701
Acronym
VALITEM
Status last verified
Mar 2023
First submitted
17 May 2016
Last updated
31 Mar 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multiple Errands Test (MET) in people with Schizophrenia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of quantitative variable between score for MET and standard functional evaluation (time frame: Inclusion visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.

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