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Completed

NCT Number: NCT02879604

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

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charles Perrens Hospital, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compensatory cognitive training

Other

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

Other names: CCT

Usual

Other

Usual care

Primary outcomes

  1. Cost-utility questionnaire

    Time frame: 12 months

    Cost difference between the 2 group of patients

Secondary outcomes

  1. Functioning questionnaire

    Time frame: 3 months

    FROGS, Functional Remission of General Schizophrenia

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

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

Registry information

Acronym: Grecco

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2016
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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