Schizophrenic Disorders
Conditions
Keywords
Schizophrenia, Neurocognition, Social cognition, Metacognition, Cognitive remediation
Brief 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.
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.
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
OTHERRecovery-Oriented Therapy
The second group will have \[THoR\] Recovery-Oriented Therapy
Sponsors
Centre hospitalier de Ville-Evrard, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
The first group is about cognitive remediation therapy (ECo-Sz). The second group is about recovery oriented therapy (ThOR).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tower of Hanoi | pre-inclusion | Tower planning total score from tower of Hanoi |
| Matrix test (WAIS-IV) | pre-inclusion | The perceptual reasoning score of the Matrix test. |
| STROOP | pre-inclusion | Interference score |
| TMTB | pre-inclusion | Trail Making Test |
| Litteral score of Verbal fluences | pre-inclusion | Litteral score of Verbal fluences |
| GO/NOGO | pre-inclusion | cognitive control score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EESEP | Eighteen week | Self-Efficacity Rating Scale - minimum value = 21 - maximum value = 105 |
| ERF | First week | Functional Impact Scale - minimum value = 5 - maximum value = 35 |
| ERF-CS | First week | Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20 |
| MCQ-30 | First week | Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120 |
| QFS | First week | Social Functioning Questionnaire - no minimum or maximum value |
| SAIQ | First week | Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68 |
| SCS | First week | Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66 |
| SDS | First week | Social Desirability Scale - minimum value = 0 - maximum value = 33 |
| STORI | First week | Stage of Recovery Instrument - minimum value = 0 - maximum value = 50 |
| Mini-500 | pre-inclusion | (Entretien structuré Neuropsychiatrique International |
| CTQ | pre-inclusion | Childhood Trauma Questionnaire - minimum value = 28 - maximum value = 112 |
| PANSS | pre-inclusion | Positive and Negative Syndrome Scale - minimum value = 30 - maximum value = 210 |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Balloon Analogue Risk Task | First week | The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value |
| ToM-15 | First week | 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 |
| Cubes Subtest | First week | Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20 |
| Visual Puzzle Subtest | First week | Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20 |
| Similiraties Subtest | First week | Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20 |
| Working Memory Subtest | First week | Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20 |
| FAUX-PAS Test | First week | 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 |
| The Rey/Taylor complex figure test | First week | 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 |
| MEM IV Logical Memory | First week | Composite score of the Weschler Memory Scale - fourth edition |
| MEM IV Symbol Memory | First week | Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20 |
| D2 Test | First week | The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value |
Countries
France
Contacts
Primary ContactDominique JANUEL, MBBS
Outcome results
None listed