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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: IPT+; Behavioral: Treatment as usual

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Delphine CAPDEVIELLE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).
Other: 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).

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Delphine CAPDEVIELLE, PU-PH, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: cognitive remediation; negative symptoms; Deficit Schizophrenia; long stay inpatients
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 9529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No