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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2023-03-28

Brief Summary

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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.

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Detailed Description

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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

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Compensatory cognitive training

Group Type EXPERIMENTAL

Compensatory cognitive training

Intervention Type OTHER

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

usual treatment

usual treatment for shizophrenai

Group Type PLACEBO_COMPARATOR

Usual

Intervention Type OTHER

Usual care

Interventions

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Compensatory cognitive training

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

Intervention Type OTHER

Usual

Usual care

Intervention Type OTHER

Other Intervention Names

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CCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No