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Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia

Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia : Impact on the Capacities of Autonomy

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03407950
Acronym
IPT+
Enrollment
0
Registered
2018-01-23
Start date
2018-01-31
Completion date
2021-09-30
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Deficit Schizophrenia, long stay inpatients, cognitive remediation, negative symptoms

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.

Interventions

BEHAVIORALIPT+

Integrated Psychological Treatment and cognitive remediation and relaxation and Mindfulness : IPT+. A blind evaluation will be realized thanks to questionnaires of the current practice to compare the IPT+ versus treatment as usual (TAU).

BEHAVIORALTreatment as usual

no specific therapy but same number and duration of each sessions than IPT+. A blind evaluation will be realized thanks to questionnaires of the current practice to compare the IPT+ versus treatment as usual (TAU).

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Social autonomy6 monthsEvaluated by Social autonomy Scale (EAS). It's a scale composing by 17 highly-rated items from 0 to 6 (total score varying 0 in 102, a low score indicating a better social autonomy).

Secondary

MeasureTime frameDescription
Clinical symptomatology6 and 12 monthsEvaluated by the Assessment of Negative Symptoms (SANS). It's a scale composing by 25 items, highly-rated from 0 to 5.
Clinical cognition6 and 12 monthsEvaluated by scale D2 test
Clinical functioning6 and 12 monthsEvaluated by scales Quality of life (S-QoL-18)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026