NCT02879604

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2023

Completed
Last Updated

September 30, 2025

Status Verified

October 1, 2023

Enrollment Period

5.1 years

First QC Date

August 17, 2016

Last Update Submit

September 29, 2025

Conditions

Schizophrenia

Keywords

cognitive remediation, cost-effectiveness analysis

Outcome Measures

Primary Outcomes (1)

  • Cost-utility questionnaire

    Cost difference between the 2 group of patients

    12 months

Secondary Outcomes (1)

  • Functioning questionnaire

    3 months

Study Arms (2)

Compensatory cognitive training

EXPERIMENTAL

Compensatory cognitive training

Other: Compensatory cognitive training

usual treatment

PLACEBO COMPARATOR

usual treatment for shizophrenai

Other: Usual

Interventions

Compensatory cognitive trainingOTHER

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

Also known as: CCT
Compensatory cognitive training
UsualOTHER

Usual care

usual treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnostic with schizophrénie
  • Less than 10 years of the evolution of the disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Charles Perrens Hospital

Bordeaux, 33076, France

Location

Le Vinatier Hospital

Bron, 69678, France

Location

Gabriel-Montpied Univesity Hospital

Clermont-Ferrand, 63003, France

Location

Louis Mourier Hospital

Colombes, 92701, France

Location

Chenevier Hospital

Créteil, 94000, France

Location

La Conception Hospital

Marseille, 13005, France

Location

Montpellier University Hospital

Montpellier, 34295, France

Location

Alpes Isère Hospital

Saint-Égrève, 38521, France

Location

Strasbourg University Hospital

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Delphine DC CAPDEVIELLE, MD-PhD

    Montpellier University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 25, 2016

Study Start

March 5, 2018

Primary Completion

March 28, 2023

Study Completion

March 28, 2023

Last Updated

September 30, 2025

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(9)