SchizophreniaGreccoNCT02879604
Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia
A study testing Compensatory cognitive training and Usual in people with Schizophrenia, run by University Hospital, Montpellier at 9 sites in France.
Trial summary
Significant cognitive impairment (executive functions, memory, attention) is common in schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and atypical antipsychotic) do not have impact on cognitive functioning. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Compensatory cognitive training and Usual
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 9 sitesFrance
- Study dates
- 5 Mar 2018to 28 Mar 2023
- 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
- Diagnostic with schizophrénie
- Less than 10 years of the evolution of the disease
Who cannot join
- History of severe cranial trauma and / or neurological pathology with cognitive impairment
- Ongoing participation in another study for treatment of negative or cognitive symptoms
- Ongoing participation in a study on management in psychotherapy for cognitive disorders and negative symptoms
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Charles Perrens Hospital
Bordeaux, 33076
Le Vinatier Hospital
Bron, 69678
Gabriel-Montpied Univesity Hospital
Clermont-Ferrand, 63003
Louis Mourier Hospital
Colombes, 92701
Chenevier Hospital
Créteil, 94000
La Conception Hospital
Marseille, 13005
Montpellier University Hospital
Montpellier, 34295
Alpes Isère Hospital
Saint-Égrève, 38521
Strasbourg University Hospital
Strasbourg, 67091
About this study
Significant cognitive impairment (executive functions, memory, attention) is common in schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and atypical antipsychotic) do not have impact on cognitive functioning. For over 20 years, alternative non-pharmacological therapeutics have been developed in schizophrenia. These techniques called cognitive remediation specifically target cognitive deficits. The first cognitive remediation available for patients was designed to stimulate new learning, or relearning, of cognitive tasks, and thus to improve certain deficient domains. These procedures were efficient in improving cognition as measured by neurocognitive tests but their impact on functioning and daily life was weak. In a second time, compensatory remediation has been developed. Compensatory approaches seek to make improvements in the patient's functioning by avoiding areas of impairment and recruiting other intact cognitive domains or by creating a supportive external environment. In recent meta-analysis compensatory remediation has larger effect-size than classical cognitive remediation, with an impact on patients psychosocial functioning. Recently, Dr E. Twamley (University of California) developed and tested a group-based, manualized, compensatory cognitive training intervention.
Compensatory cognitive training (CCT) is a low-tech, brief intervention and is easily transposable in community care. Our team translated this method into French. The investigators planned a cost -utility study between CCT and treatment as usual in schizophrenia patients with less than 10 years of evolution.
Read the detailed description
This study will take place over 3 years with a recruitment period of 18 months. After verification of the eligibility criteria and signature of the consent, the patients will be divided into 2 groups by randomization: the intervention group and the control group. The duration of participation of the subjects will be 12 months. Assessments are available in 4 steps (V1 at inclusion, V2 at 3 months, V3 at 6 months and V4 at 12 months). These visits include an assessment of the functioning of patients, symptomatology, quality of life, treatment and care received at all visits, occupational activity and cognitive assessment and social knowledge at V1 and V4.
- Conditions
- Schizophrenia
- Being tested
- Compensatory cognitive training, Usual
- Keywords
- cognitive remediation, cost-effectiveness analysis
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compensatory cognitive trainingOther
Also called CCT
In addition to the usual care, method of compensatory cognitive remediation
UsualOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Compensatory cognitive training | Experimental | Compensatory cognitive training Receives: Other: Compensatory cognitive training |
| usual treatment | Placebo comparator | usual treatment for shizophrenai Receives: Other: Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-utility questionnaire
Cost difference between the 2 group of patients
Measured: 12 months
Secondary outcomes (1)
Functioning questionnaire
FROGS, Functional Remission of General Schizophrenia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start5 Mar 2018
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille, University Hospital, Clermont-Ferrand, Assistance Publique - Hôpitaux de Paris, Hôpital Louis Mourier, Centre Hospitalier Charles Perrens, Bordeaux, University Hospital, Strasbourg, Hospital Center Alpes-Isère, Hôpitaux à Bron, Fondation FondaMental
- Responsible party
- Sponsor
- Investigators
- Delphine DC CAPDEVIELLE, MD-PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879604
- Sponsor's protocol ID
- RECHMPL15_0503
- Acronym
- Grecco
- Status last verified
- Oct 2023
- First submitted
- 17 Aug 2016
- Last updated
- 30 Sep 2025
- 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 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia
- ClinicalTrials.gov ID
- NCT02879604
- Acronym / sponsor ID
- Grecco / RECHMPL15_0503
- Conditions
- Schizophrenia
- Keywords
- cognitive remediation, cost-effectiveness analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Assistance Publique Hopitaux De Marseille, University Hospital, Clermont-Ferrand, Assistance Publique - Hôpitaux de Paris, Hôpital Louis Mourier, Centre Hospitalier Charles Perrens, Bordeaux, University Hospital, Strasbourg, Hospital Center Alpes-Isère, Hôpitaux à Bron, Fondation FondaMental
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 25 Aug 2016 (estimated)
- 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.
Significant cognitive impairment (executive functions, memory, attention) is common in schizophrenia affecting up to 80% of patients. But pharmacological treatments (typical and atypical antipsychotic) do not have impact on cognitive functioning. For over 20 years, alternative non-pharmacological therapeutics have been developed in schizophrenia. These techniques called cognitive remediation specifically target cognitive deficits. The first cognitive remediation available for patients was designed to stimulate new learning, or relearning, of cognitive tasks, and thus to improve certain deficient domains. These procedures were efficient in improving cognition as measured by neurocognitive tests but their impact on functioning and daily life was weak. In a second time, compensatory remediation has been developed. Compensatory approaches seek to make improvements in the patient's functioning by avoiding areas of impairment and recruiting other intact cognitive domains or by creating a supportive external environment. In recent meta-analysis compensatory remediation has larger effect-size than classical cognitive remediation, with an impact on patients psychosocial functioning. Recently, Dr E. Twamley (University of California) developed and tested a group-based, manualized, compensatory cognitive training intervention.
Compensatory cognitive training (CCT) is a low-tech, brief intervention and is easily transposable in community care. Our team translated this method into French. The investigators planned a cost -utility study between CCT and treatment as usual in schizophrenia patients with less than 10 years of evolution.
Detailed description
This study will take place over 3 years with a recruitment period of 18 months. After verification of the eligibility criteria and signature of the consent, the patients will be divided into 2 groups by randomization: the intervention group and the control group. The duration of participation of the subjects will be 12 months. Assessments are available in 4 steps (V1 at inclusion, V2 at 3 months, V3 at 6 months and V4 at 12 months). These visits include an assessment of the functioning of patients, symptomatology, quality of life, treatment and care received at all visits, occupational activity and cognitive assessment and social knowledge at V1 and V4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compensatory cognitive training | Experimental | Other: Compensatory cognitive trainingCompensatory cognitive training |
| usual treatment | Placebo comparator | Other: Usualusual treatment for shizophrenai |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnostic with schizophrénie
- Less than 10 years of the evolution of the disease
Key exclusion criteria (3 listed)
- History of severe cranial trauma and / or neurological pathology with cognitive impairment
- Ongoing participation in another study for treatment of negative or cognitive symptoms
- Ongoing participation in a study on management in psychotherapy for cognitive disorders and negative symptoms
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 |
|---|---|---|
| Compensatory cognitive trainingAlso: CCTIn addition to the usual care, method of compensatory cognitive remediation | Other | Compensatory cognitive training |
| UsualUsual care | Other | usual treatment |
Primary outcome
Cost-utility questionnaire
Time frame: 12 months
Cost difference between the 2 group of patients
1 secondary outcome
Functioning questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- 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.
Delphine DC CAPDEVIELLE, MD-PhD study director
University Hospital, Montpellier
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compensatory cognitive training and Usual in people with Schizophrenia, run by University Hospital, Montpellier at 9 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 2 inclusion and 3 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 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. Some participants in this study may receive a placebo. 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?
Cost-utility questionnaire (time frame: 12 months). 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 30 Sep 2025.