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

Study Overview
=================
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.

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

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: IPT+
* Behavioral: Treatment as usual


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group IPT+<br>2 sessions of IPT+ by week during 6 months | Behavioral: IPT+<br>* 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).<br>|
| Other: Control Group<br>group without specific therapy (Treatment as usual) but same number and duration of each sessions than IPT+ | Behavioral: Treatment as usual<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social autonomy | Evaluated 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptomatology | Evaluated by the Assessment of Negative Symptoms (SANS). It's a scale composing by 25 items, highly-rated from 0 to 5. | 6 and 12 months | 
| Clinical symptomatology | Evaluated by the Lille Apathy Rating Scale (LARS). It's a scale composing by 33 questions distributed in 9 columns. A global score is calculated varying of 36-22 (No apathetic person), 21-17 (trend to the apathy), -16 in -10 (Moderate apathy) and of -9 has + 36 (Severe apathy). | 6 and 12 months | 
| Clinical symptomatology | Evaluated by the Social Anhedonia Scale (SAS). It's a scale composing by 40 items quoted by the subject in truth or false. | 6 and 12 months | 
| Clinical cognition | Evaluated by scale D2 test | 6 and 12 months | 
| Clinical cognition | Evaluated by scale Trail Making Test (TMT) | 6 and 12 months | 
| Clinical cognition | Evaluated by scale California Verbal Learning Test (CVLT) | 6 and 12 months | 
| Clinical cognition | Evaluated by scale WAIS III. The total score varies between 0 and 21 | 6 and 12 months | 
| Clinical cognition | Evaluated by scale ER-40. It's an computer-based testing translates into French and which lasts 6 minutes. It consists with 40 photos of faces expressing 4 basic feelings (enjoyment, sadness, anger and fear) or neutrals. In every thrown image, 5 choices of feelings are possible. | 6 and 12 months | 
| Clinical cognition | Evaluated by Social cognition. A score of global social support will be estimated, between 0 (no knowledge, no possibility of emotional or financial support by other people) and 5 (patient having the possibility of living or living at a close person, anybody () gets fresh ideas worrying about the patient and about his coverage(care) and suggesting accompanying him(it) in the diverse administrative procedures or with care, very supported and varied emotional circle of acquaintances, possible financial support by the close friends(relations) and the guarantor(respondent) entirely for the necessities of the patient). | 6 and 12 months | 
| Clinical cognition | Evaluated by scale to assess Unawareness of Mental Disorder (SUMD). The answers are quoted(esteemed) from 1 to 5. The highest scores indicate the highest levels of non-consciousness of the disorder. | 6 and 12 months | 
| Clinical functioning | Evaluated by scales Quality of life (S-QoL-18) | 6 and 12 months | 
| Clinical functioning | Evaluated by scale Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). Items are quoted of 1 (never) in 5 (all the time) giving a total score between 14 and 70. | 6 and 12 months | 
| Clinical functioning | Evaluated by scale Emotional Reactivity Scale (ERS). The 13 items are quoted of 0 (never) in 4 (always). | 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deficit Schizophrenia, long stay inpatients, cognitive remediation, negative symptoms