ClinicalTrials.Veeva

Menu

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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Schizophrenia

Treatments

Other: Compensatory cognitive training
Other: Usual

Study type

Interventional

Funder types

Other

Identifiers

NCT02879604
UF 9679

Details and patient eligibility

About

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.

Full 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.

Enrollment

218 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

218 participants in 2 patient groups, including a placebo group

Compensatory cognitive training
Experimental group
Description:
Compensatory cognitive training
Treatment:
Other: Compensatory cognitive training
usual treatment
Placebo Comparator group
Description:
usual treatment for shizophrenai
Treatment:
Other: Usual

Trial contacts and locations

9

Loading...

Central trial contact

Delphine CD Capdevielle, MD-PhD; Stéphane SR Raffard, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems