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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Compensatory cognitive training
Usual
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring cognitive remediation, cost-effectiveness analysis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Charles Perrens Hospital
  • Le Vinatier Hospital
  • Gabriel-Montpied Univesity Hospital
  • Louis Mourier Hospital
  • Chenevier Hospital
  • La Conception Hospital
  • Montpellier University Hospital
  • Alpes Isère Hospital
  • Strasbourg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Compensatory cognitive training

usual treatment

Arm Description

Compensatory cognitive training

usual treatment for shizophrenai

Outcomes

Primary Outcome Measures

Cost-utility questionnaire
Cost difference between the 2 group of patients

Secondary Outcome Measures

Functioning questionnaire
FROGS, Functional Remission of General Schizophrenia

Full Information

First Posted
August 17, 2016
Last Updated
October 2, 2023
Sponsor
University Hospital, Montpellier
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT02879604
Brief Title
Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia
Acronym
Grecco
Official Title
Cost-utility Study of a Group of Compensatory Cognitive Remediation in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
March 28, 2023 (Actual)
Study Completion Date
March 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
cognitive remediation, cost-effectiveness analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compensatory cognitive training
Arm Type
Experimental
Arm Description
Compensatory cognitive training
Arm Title
usual treatment
Arm Type
Placebo Comparator
Arm Description
usual treatment for shizophrenai
Intervention Type
Other
Intervention Name(s)
Compensatory cognitive training
Other Intervention Name(s)
CCT
Intervention Description
In addition to the usual care, method of compensatory cognitive remediation
Intervention Type
Other
Intervention Name(s)
Usual
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Cost-utility questionnaire
Description
Cost difference between the 2 group of patients
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Functioning questionnaire
Description
FROGS, Functional Remission of General Schizophrenia
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine DC CAPDEVIELLE, MD-PhD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Charles Perrens Hospital
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Le Vinatier Hospital
City
Bron
ZIP/Postal Code
69678
Country
France
Facility Name
Gabriel-Montpied Univesity Hospital
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Louis Mourier Hospital
City
Colombes
ZIP/Postal Code
92701
Country
France
Facility Name
Chenevier Hospital
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
La Conception Hospital
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Alpes Isère Hospital
City
Saint-Égrève
ZIP/Postal Code
38521
Country
France
Facility Name
Strasbourg University Hospital
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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