Clinical trial NCT02879604: Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia
Official title: Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: cognitive remediation, cost-effectiveness analysis
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Assistance Publique Hopitaux De Marseille
name: University Hospital, Clermont-Ferrand
name: Assistance Publique - Hôpitaux de Paris
name: Hôpital Louis Mourier
name: Centre Hospitalier Charles Perrens, Bordeaux
name: University Hospital, Strasbourg
name: Hospital Center Alpes-Isère
name: Hôpitaux à Bron
name: Fondation FondaMental
First posted: 2016-08-25
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cost-utility questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Functioning questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Charles Perrens Hospital
city: Bron
country: France
facility: Le Vinatier Hospital
city: Clermont-Ferrand
country: France
facility: Gabriel-Montpied Univesity Hospital
city: Colombes
country: France
facility: Louis Mourier Hospital
city: Créteil
country: France
facility: Chenevier Hospital
city: Marseille
country: France
facility: La Conception Hospital
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Saint-Égrève
country: France
facility: Alpes Isère Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
Study officials:
affiliation: Montpellier University Hospital
name: Delphine DC CAPDEVIELLE, MD-PhD
role: STUDY_DIRECTOR
References: