Clinical trial NCT03407950: Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia
Official title: Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia : Impact on the Capacities of Autonomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Schizophrenia
Keywords: Deficit Schizophrenia
long stay inpatients
cognitive remediation
negative symptoms
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Schizophrenia is a chronic disease with deficit in social interaction and lost of autonomy in daily life. Negative symptoms as blunted affect, avolition, social deficit and anhedonia and cognition were prognosis and functioning key's factors. Psychotropic medications have shown only poor effect to improve negative symptoms and cognition as attention, memory and cognitive flexibility. So, cognitive remediation programs were developped to focus cognitive disorders. The IPT (Integrated Psychological Treatment) is one of the most complete program with modules on cognitive and social abilities. The aim of this study is to evaluate the efficacy of IPT+ program to improve autonomy capacities of long stay inpatients suffering from schizophrenia 6 at the end of the program With IPT+ this study will improve autonomy capacities for patients suffering from deficit schizophrenia and allowed patients to go out hospital earlier than before.

Detailed description: Schizophrenia is a chronic disease with deficit in social interaction and lost of autonomy in daily life. Negative symptoms as blunted affect, avolition, social deficit and anhedonia and cognition were prognosis and functioning key's factors. Psychotropic medications have shown only poor effect to improve negative symptoms and cognition as attention, memory and cognitive flexibility. So, cognitive remediation programs were developped to focus cognitive disorders. The IPT (Integrated Psychological Treatment) is one of the most complete program with modules on cognitive and social abilities. The aim of this study is to evaluate the efficacy of IPT+ program to improve autonomy capacities of long stay inpatients suffering from schizophrenia 6 at the end of the program The secondary objectives are to evaluate autonomy 6 months after the program, to evaluate the efficacy of the program on negative symptoms, quality of life, cognitive functions, social cognition and duration of hospitalisation.

This study propose a randomised controlled study with 2 arms, with blind evaluation to compare the IPT+ versus treatment as usual (TAU). The follow up will be 6 month for the With IPT+ this study will improve autonomy capacities for patients suffering from deficit schizophrenia and allowed patients to go out hospital earlier than before.

Eligibility criteria: Inclusion criteria:

* age \> 18 and \< 60
* Diagnosis of schizophrenia on DSM 5
* criteria of deficit schizophrenia with the schedule for deficit syndrome
* inpatient at inclusion with at least 6 month of hospitalisation during the last 2 years
* clinically stable
* able to understand, talk and read french
* signing consent form

Exclusion criteria:

* change in psychotropic treatment during the last month
* psychotherapy in the last 8 months or planned during the study
* CDSS score \> 9
* drug dependency during the last year
* unstable somatic disease
* somatic disease with impact on cognition

Primary outcomes:
measure: Social autonomy
timeFrame: 6 months
Secondary outcomes:
measure: Clinical symptomatology
timeFrame: 6 and 12 months
measure: Clinical symptomatology
timeFrame: 6 and 12 months
measure: Clinical symptomatology
timeFrame: 6 and 12 months
measure: Clinical cognition
timeFrame: 6 and 12 months
measure: Clinical cognition
timeFrame: 6 and 12 months
measure: Clinical cognition
timeFrame: 6 and 12 months
measure: Clinical cognition
timeFrame: 6 and 12 months
measure: Clinical cognition
timeFrame: 6 and 12 months
measure: Clinical cognition
timeFrame: 6 and 12 months
measure: Clinical cognition
timeFrame: 6 and 12 months
measure: Clinical functioning
timeFrame: 6 and 12 months
measure: Clinical functioning
timeFrame: 6 and 12 months
measure: Clinical functioning
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Delphine CAPDEVIELLE
Study officials:
affiliation: University Hospital, Montpellier
name: Delphine CAPDEVIELLE, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: