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Trial record 6 of 95 for:    Not yet recruiting Studies | schizophrenia

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

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ClinicalTrials.gov Identifier: NCT03407950
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: IPT+ Behavioral: Treatment as usual Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Remediation Program for Hospitalized in the Long Term Patients With Deficit Schizophrenia : Impact on the Capacities of Autonomy
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Group IPT+
2 sessions of IPT+ by week during 6 months
Behavioral: IPT+
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).

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




Primary Outcome Measures :
  1. Social autonomy [ Time Frame: 6 months ]
    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 :
  1. Clinical symptomatology [ Time Frame: 6 and 12 months ]
    Evaluated by the Assessment of Negative Symptoms (SANS). It's a scale composing by 25 items, highly-rated from 0 to 5.

  2. Clinical symptomatology [ Time Frame: 6 and 12 months ]
    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).

  3. Clinical symptomatology [ Time Frame: 6 and 12 months ]
    Evaluated by the Social Anhedonia Scale (SAS). It's a scale composing by 40 items quoted by the subject in "truth" or "false".

  4. Clinical cognition [ Time Frame: 6 and 12 months ]
    Evaluated by scale D2 test

  5. Clinical cognition [ Time Frame: 6 and 12 months ]
    Evaluated by scale Trail Making Test (TMT)

  6. Clinical cognition [ Time Frame: 6 and 12 months ]
    Evaluated by scale California Verbal Learning Test (CVLT)

  7. Clinical cognition [ Time Frame: 6 and 12 months ]
    Evaluated by scale WAIS III. The total score varies between 0 and 21

  8. Clinical cognition [ Time Frame: 6 and 12 months ]
    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.

  9. Clinical cognition [ Time Frame: 6 and 12 months ]
    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).

  10. Clinical cognition [ Time Frame: 6 and 12 months ]
    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.

  11. Clinical functioning [ Time Frame: 6 and 12 months ]
    Evaluated by scales Quality of life (S-QoL-18)

  12. Clinical functioning [ Time Frame: 6 and 12 months ]
    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.

  13. Clinical functioning [ Time Frame: 6 and 12 months ]
    Evaluated by scale Emotional Reactivity Scale (ERS). The 13 items are quoted of 0 (never) in 4 (always).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407950


Contacts
Contact: Delphine CAPDEVIELLE, PU-PH 467339702 ext +33 d-capdevielle@chu-montpellier.fr
Contact: Aurore LARUE, PH aurore.larue@ch-thuir.fr

Locations
France
Delphine CAPDEVIELLE Not yet recruiting
Montpellier, France, 34295
Contact: Delphine CAPDEVIELLE, PU-PH       d-capdevielle@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Delphine CAPDEVIELLE, PU-PH University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03407950     History of Changes
Other Study ID Numbers: 9529
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
Deficit Schizophrenia
long stay inpatients
cognitive remediation
negative symptoms

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders