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

This study is not yet open for participant recruitment.
Verified September 2017 by University Hospital, Montpellier
Sponsor:
ClinicalTrials.gov Identifier:
NCT02879604
First Posted: August 25, 2016
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Assistances publiques hopitaux de Marseille
University Hospital, Clermont-Ferrand
Assistances publiques hopitaux de Paris
Hôpital Louis Mourier, Colombes
Hôpital Charles Perrens, Bordeaux
CHRU Strasbourg
Hospital Center Alpes-Isère
Centre Hospitalier le Vinatier, Bron
Laboratoire Santé Publique - Faculté de Médecine - Marseille
Fondation FondaMental
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose

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 Intervention
Schizophrenia Other: Compensatory cognitive training Other: Usual

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Cost-utility questionnaire [ Time Frame: 12 months ]
    Cost difference between the 2 group of patients


Secondary Outcome Measures:
  • Functioning questionnaire [ Time Frame: 3 months ]
    FROGS, Functional Remission of General Schizophrenia


Estimated Enrollment: 210
Anticipated Study Start Date: September 2017
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Compensatory cognitive training
Compensatory cognitive training
Other: Compensatory cognitive training
In addition to the usual care, method of compensatory cognitive remediation
Other Name: CCT
Placebo Comparator: usual treatment
usual treatment for shizophrenai
Other: Usual
Usual care

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879604


Contacts
Contact: Delphine Capdevielle, MD-PhD 033467339727 d-capdevielle@chu-montpellier.fr
Contact: Stéphane Raffard, PhD 033467339702 s-raffard@chu-montpellier.fr

Sponsors and Collaborators
University Hospital, Montpellier
Assistances publiques hopitaux de Marseille
University Hospital, Clermont-Ferrand
Assistances publiques hopitaux de Paris
Hôpital Louis Mourier, Colombes
Hôpital Charles Perrens, Bordeaux
CHRU Strasbourg
Hospital Center Alpes-Isère
Centre Hospitalier le Vinatier, Bron
Laboratoire Santé Publique - Faculté de Médecine - Marseille
Fondation FondaMental
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02879604     History of Changes
Other Study ID Numbers: UF 9679
First Submitted: August 17, 2016
First Posted: August 25, 2016
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
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
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders