CClinicalTrials.gg
RecruitingNCT04608032NARCISUpdated Feb 9, 2024

Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia

An interventional study of [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder and Recovery-Oriented Therapy in Schizophrenic Disorders, sponsored by Centre hospitalier de Ville-Evrard, France. Recruiting at 2 sites in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by Centre hospitalier de Ville-Evrard, France · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Sep 2020; still recruiting 6 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study evaluates the effect of a cognitive remediation program on neurocognitive, social cognitive and metacognitive functions designed for patients living with a schizophrenia spectrum disorder.

Read the detailed description

Evaluation of the specific therapeutic efficacy of the ecological cognitive remediation program for schizophrenia spectrum disorder [ECo-Sz] on neurocognitive deficits, social cognition deficits and metacognition deficits of patients with a schizophrenia spectrum disorder.

In this double-blind (patients, outcomes assessors) controlled randomized trial the investigators compare patients receiving Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz] to patients benefiting from recovery-oriented therapy [ThOR]. Patients are treated for two months and monitored for four months.

02

Conditions studied

  • Schizophrenic Disorders

Keywords

  • Schizophrenia
  • Neurocognition
  • Social cognition
  • Metacognition
  • Cognitive remediation
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 70 is close to the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Centre hospitalier de Ville-Evrard, France is the lead sponsor of 22 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Schizophrenia Disorder diagnosis, according to Diagnostic and Statistical Manual of mental disorders - Fifth edition (DSM-V) - Patient stabilized in terms of positive and negative symptomatology (absence or presence of weak positive and negative symptoms)
  • Positive and Negative stable symptoms (no or few positive and negative symptoms)
  • Stable and effective minimum dose of medication (antipsychotic) for the last three months
  • Cognitive complaint expressed by the patient
  • Informed consent form read, initialed and signed
  • Understanding of spoken and read French
  • Patient registered on the social welfare system

Exclusion criteria

Exclusion Criteria:

  • Other diagnosis at the forefront than Schizophrenia of the DSM-V
  • Medical history neurological disorder resulting in hospitalization
  • Acute episode in the last three month
  • Somatic disorders resulting in cognitive impairment
  • Engagement in a research protocol either currently or over the last month
  • Neuropsychological assessment evaluation during the last six month
  • Patients under the protection of a conservator (simple or reinforced)
  • Individuals in vulnerable circumstances
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz]

    To inform the patient about cognitive impairments and their repercussions ; to train the patient in problem-solving skills through exercices ; to implement strategies in daily life. Duration : two month. Frequency : Two one hour individual sessions and one hour of at-home training per week. Modalities : pen and papers exercices (tools, token, cards, maps and chessboard). Modules : Psychoeducation, Attention, Memory, Executive functions, Social cognition and metacognition, Functional impairments

    Other: [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder

  • Active comparator
    [THoR] Recovery-Oriented Therapy

    Individual psychotherapy sessions focussing on autonomy in daily life, management of mood disorders' and functional impact, social skills, motivation and the regulation of sleep and daily activities

    Other: Recovery-Oriented Therapy

Interventions

  • Other[Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder

    The first group will have \[Eco-Sz\] Ecological Cognitive training program for schizophrenia spectrum disorder

    Also known as: [Eco-Sz]

  • OtherRecovery-Oriented Therapy

    The second group will have \[THoR\] Recovery-Oriented Therapy

    Also known as: [THoR]

06

What researchers measure

Primary outcomes

  1. STROOP

    Interference score

    Time frame: pre-inclusion

  2. TMTB

    Trail Making Test

    Time frame: pre-inclusion

  3. Litteral score of Verbal fluences

    Litteral score of Verbal fluences

    Time frame: pre-inclusion

  4. GO/NOGO

    cognitive control score

    Time frame: pre-inclusion

  5. tower of Hanoi

    Tower planning total score from tower of Hanoi

    Time frame: pre-inclusion

  6. Matrix test (WAIS-IV)

    The perceptual reasoning score of the Matrix test.

    Time frame: pre-inclusion

Secondary outcomes

  1. Mini-500

    (Entretien structuré Neuropsychiatrique International

    Time frame: pre-inclusion

  2. CTQ

    Childhood Trauma Questionnaire - minimum value = 28 - maximum value = 112

    Time frame: pre-inclusion

  3. PANSS

    Positive and Negative Syndrome Scale - minimum value = 30 - maximum value = 210

    Time frame: pre-inclusion

  4. EESEP

    Self-Efficacity Rating Scale - minimum value = 21 - maximum value = 105

    Time frame: Eighteen week

  5. EESEP

    Self-Efficacity Rating Scale - minimum value = 21 - maximum value = 105

    Time frame: Twenty six week

  6. ERF

    Functional Impact Scale - minimum value = 5 - maximum value = 35

    Time frame: First week

  7. ERF

    Functional Impact Scale - minimum value = 5 - maximum value = 35

    Time frame: Ten week

  8. ERF

    Functional Impact Scale - minimum value = 5 - maximum value = 35

    Time frame: Eighteen week

  9. ERF

    Functional Impact Scale - minimum value = 5 - maximum value = 35

    Time frame: Twenty six week

  10. ERF-CS

    Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20

    Time frame: First week

  11. ERF-CS

    Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20

    Time frame: Ten week

  12. ERF-CS

    Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20

    Time frame: Eighteen week

  13. ERF-CS

    Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20

    Time frame: Twenty six week

  14. MCQ-30

    Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120

    Time frame: First week

  15. MCQ-30

    Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120

    Time frame: Ten week

  16. MCQ-30

    Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120

    Time frame: Eighteen week

  17. MCQ-30

    Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120

    Time frame: Twenty six week

  18. QFS

    Social Functioning Questionnaire - no minimum or maximum value

    Time frame: First week

  19. QFS

    Social Functioning Questionnaire - no minimum or maximum value

    Time frame: Ten week

  20. QFS

    Social Functioning Questionnaire - no minimum or maximum value

    Time frame: Eighteen week

  21. QFS

    Social Functioning Questionnaire - no minimum or maximum value

    Time frame: Twenty six week

  22. SAIQ

    Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68

    Time frame: First week

  23. SAIQ

    Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68

    Time frame: Ten week

  24. SAIQ

    Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68

    Time frame: Eighteen week

  25. SAIQ

    Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68

    Time frame: Twenty six week

  26. SCS

    Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66

    Time frame: First week

  27. SCS

    Revised Self-Consciousness Scale- minimum value = 0 - maximum value = 66

    Time frame: Ten week

  28. SCS

    Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66

    Time frame: Eighteen week

  29. SCS

    Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66

    Time frame: Twenty six week

  30. SDS

    Social Desirability Scale - minimum value = 0 - maximum value = 33

    Time frame: First week

  31. SDS

    Social Desirability Scale - minimum value = 0 - maximum value = 33

    Time frame: Ten week

  32. SDS

    Social Desirability Scale - minimum value = 0 - maximum value = 33

    Time frame: Eighteen week

  33. SDS

    Social Desirability Scale - minimum value = 0 - maximum value = 33

    Time frame: Twenty six week

  34. STORI

    Stage of Recovery Instrument - minimum value = 0 - maximum value = 50

    Time frame: First week

  35. STORI

    Stage of Recovery Instrument - minimum value = 0 - maximum value = 50

    Time frame: Ten week

  36. STORI

    Stage of Recovery Instrument - minimum value = 0 - maximum value = 50

    Time frame: Eighteen week

  37. STORI

    Stage of Recovery Instrument - minimum value = 0 - maximum value = 50

    Time frame: Twenty six week

Other outcomes

  1. FAUX-PAS Test

    A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters - minimum value = 0 - maximum value = 60

    Time frame: First week

  2. FAUX-PAS Test

    A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters - minimum value = 0 - maximum value = 60

    Time frame: Ten week week

  3. FAUX-PAS Test

    A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters - minimum value = 0 - maximum value = 60

    Time frame: Eighteen week week

  4. FAUX-PAS Test

    A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters - minimum value = 0 - maximum value = 60

    Time frame: Twenty six week

  5. The Rey/Taylor complex figure test

    The test is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by ping it freehand and then drawing from memory. This test permits the evaluation of visuospatial abilities, memory, attention, planning and working memory - minimum value = 0 - maximum value = 36

    Time frame: First week

  6. The Rey/Taylor complex figure test

    The test is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by ping it freehand and then drawing from memory. This test permits the evaluation of visuospatial abilities, memory, attention, planning and working memory - minimum value = 0 - maximum value = 36

    Time frame: Ten week

  7. The Rey/Taylor complex figure test

    The test is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by ping it freehand and then drawing from memory. This test permits the evaluation of visuospatial abilities, memory, attention, planning and working memory - minimum value = 0 - maximum value = 36

    Time frame: Eighteen week

  8. The Rey/Taylor complex figure test

    The test is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by ping it freehand and then drawing from memory. This test permits the evaluation of visuospatial abilities, memory, attention, planning and working memory - minimum value = 0 - maximum value = 36

    Time frame: Twenty six week

  9. MEM IV Logical Memory

    Composite score of the Weschler Memory Scale - fourth edition

    Time frame: First week

  10. MEM IV Logical Memory

    Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Ten week

  11. MEM IV Logical Memory

    Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Eighteen week

  12. MEM IV Logical Memory

    Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Twenty six week

  13. MEM IV Symbol Memory

    Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: First week

  14. MEM IV Symbol Memory

    Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Ten week

  15. MEM IV Symbol Memory

    Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Eighteen week

  16. MEM IV Symbol Memory

    Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Twenty six week

  17. The Balloon Analogue Risk Task

    The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value

    Time frame: First week

  18. The Balloon Analogue Risk Task

    The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value

    Time frame: Ten week

  19. The Balloon Analogue Risk Task

    The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value

    Time frame: Eighteen week

  20. The Balloon Analogue Risk Task

    The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value

    Time frame: Twenty six week

  21. D2 Test

    The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value

    Time frame: First week

  22. D2 Test

    The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value

    Time frame: Ten week

  23. D2 Test

    The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value

    Time frame: Eighteen week

  24. D2 Test

    The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value

    Time frame: Twenty six week

  25. ToM-15

    The test is a task assessing theory of mind abilities you cannot move more than one disk at a time; a disk can only be placed on another disk larger than it or on an empty location - no minimum or maximum value

    Time frame: First week

  26. ToM-15

    The test is a task assessing theory of mind abilities you cannot move more than one disk at a time; a disk can only be placed on another disk larger than it or on an empty location - no minimum or maximum value

    Time frame: Ten week

  27. ToM-15

    The test is a task assessing theory of mind abilities you cannot move more than one disk at a time; a disk can only be placed on another disk larger than it or on an empty location - no minimum or maximum value

    Time frame: Eighteen week

  28. ToM-15

    The test is a task assessing theory of mind abilities you cannot move more than one disk at a time; a disk can only be placed on another disk larger than it or on an empty location - no minimum or maximum value

    Time frame: Twenty six week

  29. Cubes Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: First week

  30. Cubes Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Ten week

  31. Cubes Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Eighteen week

  32. Cubes Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Twenty six week

  33. Visual Puzzle Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: First week

  34. Visual Puzzle Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Ten week

  35. Visual Puzzle Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Eighteen week

  36. Visual Puzzle Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Twenty six week

  37. Similiraties Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: First week

  38. Similiraties Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Ten week

  39. Similiraties Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Eighteen week

  40. Similiraties Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Twenty six week

  41. Working Memory Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: First week

  42. Working Memory Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Ten week

  43. Working Memory Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Eighteen week

  44. Working Memory Subtest

    Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20

    Time frame: Twenty six week

07

Study locations

2 of 2 sites recruiting
  • Ch Ville Evrard
    Neuilly-sur-Marne, 93330, France
    • Clémence Isaac, MSC · Contact · clm.isaac@gmail.com · 0143093232
    • Clémence ISAAC, MBBS · Principal investigator
    Recruiting
  • URC Ville Evrard
    Neuilly-sur-Marne, 93330, France
    • Clémence ISAAC, PHD · Contact · clm.isaac@gmail.com · 0143093232
    • Youcef BENCHERIF, CRA · Contact · y.bencherif@epsve.fr · 0143093232
    • Clémence ISAAC, PHD · Principal investigator
    • Alex MOTUT, MSC · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04608032
Lead sponsor
Centre hospitalier de Ville-Evrard, France
Responsible party
Clémence ISAAC (Principal Investigator, Centre hospitalier de Ville-Evrard, France) — Principal investigator
First posted
Oct 29, 2020
Start date
Sep 8, 2020
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Feb 9, 2024

Study contacts

Dominique JANUEL, MBBS
Contact
d.januel@epsve.fr
0143093232
Clémence ISAAC, PHD
principal investigator · URC EPS Ville Evrard

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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