NCT03407950

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

2.9 years

First QC Date

November 14, 2017

Last Update Submit

May 19, 2021

Conditions

Schizophrenia

Keywords

Deficit Schizophrenialong stay inpatientscognitive remediationnegative symptoms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Clinical symptomatology

    6 and 12 months

  • Clinical symptomatology

    6 and 12 months

  • Clinical symptomatology

    6 and 12 months

  • Clinical cognition

    6 and 12 months

  • Clinical cognition

    6 and 12 months

  • +8 more secondary outcomes

Study Arms (2)

Group IPT+

OTHER

2 sessions of IPT+ by week during 6 months

Behavioral: IPT+

Control Group

OTHER

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

Behavioral: Treatment as usual

Interventions

IPT+BEHAVIORAL

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).

Group IPT+
Treatment as usualBEHAVIORAL

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).

Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age \> 18 and \< 60
  • Diagnosis of schizophrenia on DSM 5
  • criteria of deficit schizophrenia with the schedule for deficit syndrome
  • clinically stable
  • able to understand, talk and read french
  • signing consent form

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delphine CAPDEVIELLE

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Delphine CAPDEVIELLE, PU-PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

January 23, 2018

Study Start

January 1, 2018

Primary Completion

December 1, 2020

Study Completion

September 1, 2021

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)