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

Schizophrenia Clinical Trial

— Grecco  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02879604
• Other study ID #: UF 9679
• Status: Completed
• Phase: N/A
• Start date: March 5, 2018
• Est. completion date: March 28, 2023

Study information

• Verified date: October 2023
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Compensatory cognitive training
In addition to the usual care, method of compensatory cognitive remediation
• Usual
Usual care

Locations

Country	Name	City	State
France	Charles Perrens Hospital	Bordeaux
France	Le Vinatier Hospital	Bron
France	Gabriel-Montpied Univesity Hospital	Clermont-Ferrand
France	Louis Mourier Hospital	Colombes
France	Chenevier Hospital	Créteil
France	La Conception Hospital	Marseille
France	Montpellier University Hospital	Montpellier
France	Alpes Isère Hospital	Saint-Égrève
France	Strasbourg University Hospital	Strasbourg

Sponsors (10)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost-utility questionnaire	Cost difference between the 2 group of patients	12 months
Secondary	Functioning questionnaire	FROGS, Functional Remission of General Schizophrenia	3 months