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Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia (IPT+)

Primary Purpose

Schizophrenia

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IPT+
Treatment as usual
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Deficit Schizophrenia, long stay inpatients, cognitive remediation, negative symptoms

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Delphine CAPDEVIELLE

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group IPT+

Control Group

Arm Description

2 sessions of IPT+ by week during 6 months

group without specific therapy (Treatment as usual) but same number and duration of each sessions than IPT+

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Clinical symptomatology
Evaluated by the Assessment of Negative Symptoms (SANS). It's a scale composing by 25 items, highly-rated from 0 to 5.
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).
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".
Clinical cognition
Evaluated by scale D2 test
Clinical cognition
Evaluated by scale Trail Making Test (TMT)
Clinical cognition
Evaluated by scale California Verbal Learning Test (CVLT)
Clinical cognition
Evaluated by scale WAIS III. The total score varies between 0 and 21
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.
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).
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.
Clinical functioning
Evaluated by scales Quality of life (S-QoL-18)
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.
Clinical functioning
Evaluated by scale Emotional Reactivity Scale (ERS). The 13 items are quoted of 0 (never) in 4 (always).

Full Information

First Posted
November 14, 2017
Last Updated
May 19, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03407950
Brief Title
Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia
Acronym
IPT+
Official Title
Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia : Impact on the Capacities of Autonomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The study stopped due to major feasibility issues and the notices was expired.
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Deficit Schizophrenia, long stay inpatients, cognitive remediation, negative symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group IPT+
Arm Type
Other
Arm Description
2 sessions of IPT+ by week during 6 months
Arm Title
Control Group
Arm Type
Other
Arm Description
group without specific therapy (Treatment as usual) but same number and duration of each sessions than IPT+
Intervention Type
Behavioral
Intervention Name(s)
IPT+
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
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).
Primary Outcome Measure Information:
Title
Social autonomy
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinical symptomatology
Description
Evaluated by the Assessment of Negative Symptoms (SANS). It's a scale composing by 25 items, highly-rated from 0 to 5.
Time Frame
6 and 12 months
Title
Clinical symptomatology
Description
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).
Time Frame
6 and 12 months
Title
Clinical symptomatology
Description
Evaluated by the Social Anhedonia Scale (SAS). It's a scale composing by 40 items quoted by the subject in "truth" or "false".
Time Frame
6 and 12 months
Title
Clinical cognition
Description
Evaluated by scale D2 test
Time Frame
6 and 12 months
Title
Clinical cognition
Description
Evaluated by scale Trail Making Test (TMT)
Time Frame
6 and 12 months
Title
Clinical cognition
Description
Evaluated by scale California Verbal Learning Test (CVLT)
Time Frame
6 and 12 months
Title
Clinical cognition
Description
Evaluated by scale WAIS III. The total score varies between 0 and 21
Time Frame
6 and 12 months
Title
Clinical cognition
Description
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.
Time Frame
6 and 12 months
Title
Clinical cognition
Description
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).
Time Frame
6 and 12 months
Title
Clinical cognition
Description
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.
Time Frame
6 and 12 months
Title
Clinical functioning
Description
Evaluated by scales Quality of life (S-QoL-18)
Time Frame
6 and 12 months
Title
Clinical functioning
Description
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.
Time Frame
6 and 12 months
Title
Clinical functioning
Description
Evaluated by scale Emotional Reactivity Scale (ERS). The 13 items are quoted of 0 (never) in 4 (always).
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine CAPDEVIELLE, PU-PH
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Delphine CAPDEVIELLE
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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