Schizophrenic DisordersNARCISNCT04608032
Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia
A study testing [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder and Recovery-Oriented Therapy in people with Schizophrenic Disorders, run by Centre hospitalier de Ville-Evrard, France at 2 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenic Disorders
- What is being tested?
- [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder and Recovery-Oriented Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Sep 2020to 1 Dec 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Ch Ville Evrard
Neuilly-sur-Marne, 93330
Clémence Isaac, MSC, 0143093232, clm.isaac@gmail.com
Clémence ISAAC, MBBS
- Recruiting
URC Ville Evrard
Neuilly-sur-Marne, 93330
Clémence ISAAC, PHD, 0143093232, clm.isaac@gmail.com
Youcef BENCHERIF, CRA, 0143093232, y.bencherif@epsve.fr
About this study
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.
- Conditions
- Schizophrenic Disorders
- Being tested
- [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder, Recovery-Oriented Therapy
- Keywords
- Schizophrenia, Neurocognition, Social cognition, Metacognition, Cognitive remediation
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorderOther
Also called [Eco-Sz]
The first group will have [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder
Recovery-Oriented TherapyOther
Also called [THoR]
The second group will have [THoR] Recovery-Oriented Therapy
| Study group | Role | What they receive |
|---|---|---|
| Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz] | Experimental | 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 Receives: Other: [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder |
| [THoR] Recovery-Oriented Therapy | Active comparator | 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 Receives: Other: Recovery-Oriented Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
STROOP
Interference score
Measured: pre-inclusion
TMTB
Trail Making Test
Measured: pre-inclusion
Litteral score of Verbal fluences
Litteral score of Verbal fluences
Measured: pre-inclusion
GO/NOGO
cognitive control score
Measured: pre-inclusion
tower of Hanoi
Tower planning total score from tower of Hanoi
Measured: pre-inclusion
Matrix test (WAIS-IV)
The perceptual reasoning score of the Matrix test.
Measured: pre-inclusion
Secondary outcomes (37)
Mini-500
(Entretien structuré Neuropsychiatrique International
Measured: pre-inclusion
CTQ
Childhood Trauma Questionnaire - minimum value = 28 - maximum value = 112
Measured: pre-inclusion
PANSS
Positive and Negative Syndrome Scale - minimum value = 30 - maximum value = 210
Measured: pre-inclusion
EESEP
Self-Efficacity Rating Scale - minimum value = 21 - maximum value = 105
Measured: Eighteen week
EESEP
Self-Efficacity Rating Scale - minimum value = 21 - maximum value = 105
Measured: Twenty six week
ERF
Functional Impact Scale - minimum value = 5 - maximum value = 35
Measured: First week
ERF
Functional Impact Scale - minimum value = 5 - maximum value = 35
Measured: Ten week
ERF
Functional Impact Scale - minimum value = 5 - maximum value = 35
Measured: Eighteen week
ERF
Functional Impact Scale - minimum value = 5 - maximum value = 35
Measured: Twenty six week
ERF-CS
Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20
Measured: First week
ERF-CS
Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20
Measured: Ten week
ERF-CS
Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20
Measured: Eighteen week
ERF-CS
Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20
Measured: Twenty six week
MCQ-30
Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120
Measured: First week
MCQ-30
Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120
Measured: Ten week
MCQ-30
Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120
Measured: Eighteen week
MCQ-30
Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120
Measured: Twenty six week
QFS
Social Functioning Questionnaire - no minimum or maximum value
Measured: First week
QFS
Social Functioning Questionnaire - no minimum or maximum value
Measured: Ten week
QFS
Social Functioning Questionnaire - no minimum or maximum value
Measured: Eighteen week
QFS
Social Functioning Questionnaire - no minimum or maximum value
Measured: Twenty six week
SAIQ
Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68
Measured: First week
SAIQ
Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68
Measured: Ten week
SAIQ
Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68
Measured: Eighteen week
SAIQ
Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68
Measured: Twenty six week
SCS
Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66
Measured: First week
SCS
Revised Self-Consciousness Scale- minimum value = 0 - maximum value = 66
Measured: Ten week
SCS
Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66
Measured: Eighteen week
SCS
Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66
Measured: Twenty six week
SDS
Social Desirability Scale - minimum value = 0 - maximum value = 33
Measured: First week
SDS
Social Desirability Scale - minimum value = 0 - maximum value = 33
Measured: Ten week
SDS
Social Desirability Scale - minimum value = 0 - maximum value = 33
Measured: Eighteen week
SDS
Social Desirability Scale - minimum value = 0 - maximum value = 33
Measured: Twenty six week
STORI
Stage of Recovery Instrument - minimum value = 0 - maximum value = 50
Measured: First week
STORI
Stage of Recovery Instrument - minimum value = 0 - maximum value = 50
Measured: Ten week
STORI
Stage of Recovery Instrument - minimum value = 0 - maximum value = 50
Measured: Eighteen week
STORI
Stage of Recovery Instrument - minimum value = 0 - maximum value = 50
Measured: Twenty six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start8 Sep 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first group is about cognitive remediation therapy (ECo-Sz). The second group is about recovery oriented therapy (ThOR).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de Ville-Evrard, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clémence ISAAC, Centre hospitalier de Ville-Evrard, France
- Investigators
- Clémence ISAAC, PHD, Principal investigator, URC EPS Ville Evrard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608032
- Sponsor's protocol ID
- 10477M-NARCIS
- Acronym
- NARCIS
- Status last verified
- Feb 2024
- First submitted
- 23 Oct 2020
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia
- ClinicalTrials.gov ID
- NCT04608032
- Acronym / sponsor ID
- NARCIS / 10477M-NARCIS
- Conditions
- Schizophrenic Disorders
- Keywords
- Schizophrenia, Neurocognition, Social cognition, Metacognition, Cognitive remediation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Centre hospitalier de Ville-Evrard, FranceUniversity, hospital or other
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The first group is about cognitive remediation therapy (ECo-Sz). The second group is about recovery oriented therapy (ThOR).
| Arm | Type | Receives |
|---|---|---|
| Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz] | Experimental | Other: [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorderTo 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 |
| [THoR] Recovery-Oriented Therapy | Active comparator | Other: Recovery-Oriented TherapyIndividual 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorderAlso: [Eco-Sz]The first group will have [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder | Other | Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz] |
| Recovery-Oriented TherapyAlso: [THoR]The second group will have [THoR] Recovery-Oriented Therapy | Other | [THoR] Recovery-Oriented Therapy |
Primary outcome
STROOP
Time frame: pre-inclusion
Interference score
TMTB
Time frame: pre-inclusion
Trail Making Test
Litteral score of Verbal fluences
Time frame: pre-inclusion
Litteral score of Verbal fluences
GO/NOGO
Time frame: pre-inclusion
cognitive control score
tower of Hanoi
Time frame: pre-inclusion
Tower planning total score from tower of Hanoi
Matrix test (WAIS-IV)
Time frame: pre-inclusion
The perceptual reasoning score of the Matrix test.
37 secondary outcomes
Mini-500
Time frame: pre-inclusion
CTQ
Time frame: pre-inclusion
PANSS
Time frame: pre-inclusion
EESEP
Time frame: Eighteen week
EESEP
Time frame: Twenty six week
ERF
Time frame: First week
ERF
Time frame: Ten week
ERF
Time frame: Eighteen week
ERF
Time frame: Twenty six week
ERF-CS
Time frame: First week
ERF-CS
Time frame: Ten week
ERF-CS
Time frame: Eighteen week
ERF-CS
Time frame: Twenty six week
MCQ-30
Time frame: First week
MCQ-30
Time frame: Ten week
MCQ-30
Time frame: Eighteen week
MCQ-30
Time frame: Twenty six week
QFS
Time frame: First week
QFS
Time frame: Ten week
QFS
Time frame: Eighteen week
QFS
Time frame: Twenty six week
SAIQ
Time frame: First week
SAIQ
Time frame: Ten week
SAIQ
Time frame: Eighteen week
SAIQ
Time frame: Twenty six week
SCS
Time frame: First week
SCS
Time frame: Ten week
SCS
Time frame: Eighteen week
SCS
Time frame: Twenty six week
SDS
Time frame: First week
SDS
Time frame: Ten week
SDS
Time frame: Eighteen week
SDS
Time frame: Twenty six week
STORI
Time frame: First week
STORI
Time frame: Ten week
STORI
Time frame: Eighteen week
STORI
Time frame: Twenty six week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clémence ISAAC, PHD principal investigator
URC EPS Ville Evrard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder and Recovery-Oriented Therapy in people with Schizophrenic Disorders, run by Centre hospitalier de Ville-Evrard, France at 2 sites 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 7 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique JANUEL, MBBS (0143093232, d.januel@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STROOP (time frame: pre-inclusion). The study lists 6 primary outcomes in all. 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 9 Feb 2024.