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SchizophreniaIPT+NCT03407950

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

A study testing IPT+ and Treatment as usual in people with Schizophrenia, run by University Hospital, Montpellier at 1 site in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
IPT+ and Treatment as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteFrance
Study dates
Jan 2018to Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Delphine CAPDEVIELLE

    Montpellier, 34295

Other trials in France

About this study

Official title: 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.

Read the 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.

Conditions
Schizophrenia
Being tested
IPT+, Treatment as usual
Keywords
Deficit Schizophrenia, long stay inpatients, cognitive remediation, negative symptoms
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPT+Behavioural

    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).

  • Treatment as usualBehavioural

    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).

Study groups in NCT03407950
Study groupRoleWhat they receive
Group IPT+Other2 sessions of IPT+ by week during 6 months
Receives: Behavioral: IPT+
Control GroupOthergroup without specific therapy (Treatment as usual) but same number and duration of each sessions than IPT+
Receives: Behavioral: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 6 months

Secondary outcomes (13)

  1. Clinical symptomatology

    Evaluated by the Assessment of Negative Symptoms (SANS). It's a scale composing by 25 items, highly-rated from 0 to 5.

    Measured: 6 and 12 months

  2. 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).

    Measured: 6 and 12 months

  3. 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".

    Measured: 6 and 12 months

  4. Clinical cognition

    Evaluated by scale D2 test

    Measured: 6 and 12 months

  5. Clinical cognition

    Evaluated by scale Trail Making Test (TMT)

    Measured: 6 and 12 months

  6. Clinical cognition

    Evaluated by scale California Verbal Learning Test (CVLT)

    Measured: 6 and 12 months

  7. Clinical cognition

    Evaluated by scale WAIS III. The total score varies between 0 and 21

    Measured: 6 and 12 months

  8. 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.

    Measured: 6 and 12 months

  9. 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).

    Measured: 6 and 12 months

  10. 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.

    Measured: 6 and 12 months

  11. Clinical functioning

    Evaluated by scales Quality of life (S-QoL-18)

    Measured: 6 and 12 months

  12. 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.

    Measured: 6 and 12 months

  13. Clinical functioning

    Evaluated by scale Emotional Reactivity Scale (ERS). The 13 items are quoted of 0 (never) in 4 (always).

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2018
  2. Study startJan 2018 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionSep 2021 (estimated)

Why it stopped: The study stopped due to major feasibility issues and the notices was expired.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03407950
Sponsor's protocol ID
9529
Acronym
IPT+
Status last verified
May 2021
First submitted
14 Nov 2017
Last updated
24 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing IPT+ and Treatment as usual in people with Schizophrenia, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social autonomy (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03407950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.

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IPT+ Clinical Trial NCT03407950 | AzTrials