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Clinical Trials/NCT02879604
NCT02879604CompletedNot Applicable

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

University Hospital, Montpellier17 sites in 1 country218 target enrollmentStarted: March 5, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
218
Locations
17
Primary Endpoint
Cost-utility questionnaire

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
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

Arms & Interventions

Compensatory cognitive training

Experimental

Compensatory cognitive training

Intervention: Compensatory cognitive training (Other)

usual treatment

Placebo Comparator

usual treatment for shizophrenai

Intervention: Usual (Other)

Outcomes

Primary Outcomes

Cost-utility questionnaire

Time Frame: 12 months

Cost difference between the 2 group of patients

Secondary Outcomes

  • Functioning questionnaire(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (17)

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