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

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT02879604
Collaborator
Assistance Publique Hopitaux De Marseille (Other), University Hospital, Clermont-Ferrand (Other), Assistance Publique - Hôpitaux de Paris (Other), Hôpital Louis Mourier (Other), Centre Hospitalier Charles Perrens, Bordeaux (Other), University Hospital, Strasbourg (Other), Hospital Center Alpes-Isère (Other), Hôpitaux à Bron (Other), Fondation FondaMental (Other)
218
Enrollment
9
Locations
2
Arms
74.9
Anticipated Duration (Months)
24.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Compensatory cognitive training
  • Other: Usual
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
218 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia
Actual Study Start Date :
Mar 5, 2018
Anticipated Primary Completion Date :
Mar 7, 2023
Anticipated Study Completion Date :
Jun 2, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Compensatory cognitive training

Compensatory cognitive training

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

    		•
    Placebo Comparator: usual treatment

    usual treatment for shizophrenai

    Other: Usual
    Usual care

    Outcome Measures

    Primary Outcome Measures

    1. Cost-utility questionnaire [12 months]

      Cost difference between the 2 group of patients

    Secondary Outcome Measures

    1. Functioning questionnaire [3 months]

      FROGS, Functional Remission of General Schizophrenia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charles Perrens Hospital Bordeaux France 33076
    2 Le Vinatier Hospital Bron France 69678
    3 Gabriel-Montpied Univesity Hospital Clermont-Ferrand France 63003
    4 Louis Mourier Hospital Colombes France 92701
    5 Chenevier Hospital Créteil France 94000
    6 La Conception Hospital Marseille France 13005
    7 Montpellier University Hospital Montpellier France 34295
    8 Alpes Isère Hospital Saint-Égrève France 38521
    9 Strasbourg University Hospital Strasbourg France 67091

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Delphine DC CAPDEVIELLE, MD-PhD, Montpellier University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT02879604
    Other Study ID Numbers:
    • UF 9679
    First Posted:
    Aug 25, 2016
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    cognitive remediation, cost-effectiveness analysis
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Dec 21, 2021