Skip to content

Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia

Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02879604
Acronym
Grecco
Enrollment
218
Registered
2016-08-25
Start date
2018-03-05
Completion date
2023-03-28
Last updated
2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

cognitive remediation, cost-effectiveness analysis

Brief 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. 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.

Interventions

In addition to the usual care, method of compensatory cognitive remediation

OTHERUsual

Usual care

Sponsors

Assistance Publique Hopitaux De Marseille
CollaboratorOTHER
University Hospital, Clermont-Ferrand
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
CollaboratorOTHER
Hôpital Louis Mourier
CollaboratorOTHER
Centre Hospitalier Charles Perrens, Bordeaux
CollaboratorOTHER_GOV
University Hospital, Strasbourg
CollaboratorOTHER
Hospital Center Alpes-Isère
CollaboratorOTHER
Hôpitaux à Bron
CollaboratorOTHER
Fondation FondaMental
CollaboratorOTHER
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Diagnostic with schizophrénie * Less than 10 years of the evolution of the disease

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Cost-utility questionnaire12 monthsCost difference between the 2 group of patients

Secondary

MeasureTime frameDescription
Functioning questionnaire3 monthsFROGS, Functional Remission of General Schizophrenia

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026