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

May 19, 2021 updated by: University Hospital, Montpellier

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Delphine CAPDEVIELLE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6 and 12 months
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).
6 and 12 months
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".
6 and 12 months
Clinical cognition
Time Frame: 6 and 12 months
Evaluated by scale D2 test
6 and 12 months
Clinical cognition
Time Frame: 6 and 12 months
Evaluated by scale Trail Making Test (TMT)
6 and 12 months
Clinical cognition
Time Frame: 6 and 12 months
Evaluated by scale California Verbal Learning Test (CVLT)
6 and 12 months
Clinical cognition
Time Frame: 6 and 12 months
Evaluated by scale WAIS III. The total score varies between 0 and 21
6 and 12 months
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.
6 and 12 months
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).
6 and 12 months
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.
6 and 12 months
Clinical functioning
Time Frame: 6 and 12 months
Evaluated by scales Quality of life (S-QoL-18)
6 and 12 months
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.
6 and 12 months
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).
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Delphine CAPDEVIELLE, PU-PH, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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