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Personalised Cognitive Remediation Therapy (pCRT) (pCRT)

Primary Purpose

Schizophrenia Schizoaffective

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Remediation Therapy
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia Schizoaffective focused on measuring Cognitive Remediation Therapy CRT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a range of 18-65 years
  • English speaking or with a good knowledge of the language
  • a diagnosis of schizophrenia or schizoaffective disorder according to the DSM- V
  • at least one year contact with mental health services,
  • a deficit (of at least one standard deviation below the mean) in at least one cognitive domain out of these three cognitive domains: memory, executive function and information processing.

Exclusion Criteria:

  • Planned medication change
  • Diagnosis of learning disability
  • Presence of cognitive deficits related to organic causes or head injury
  • Primary diagnosis of substance dependence

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Personalised Cognitive Remediation Therapy (pCRT)

    Arm Description

    A case-control study design with pre- and post-therapy assessment, comparing a group of participants with schizophrenia who received standard CRT, with a similar group of participants receiving pCRT.

    Outcomes

    Primary Outcome Measures

    Feasibility of intervention (including acceptance rates, drop outs)
    Feasibility estimates of delivering the intervention including acceptance rates, drop outs.

    Secondary Outcome Measures

    Acceptability of intervention (Satisfaction)
    Questionnaire of Satisfaction

    Full Information

    First Posted
    February 15, 2018
    Last Updated
    August 13, 2018
    Sponsor
    King's College London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03461432
    Brief Title
    Personalised Cognitive Remediation Therapy (pCRT)
    Acronym
    pCRT
    Official Title
    Testing the Feasibility and Acceptability of a New Personalised Form of Cognitive Remediation Therapy (pCRT) for People With Psychosis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 31, 2018 (Anticipated)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    King's College London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Cognitive deficits have been shown to have negative impact on social functioning and functional goals such as ability to work and perform daily tasks in people with schizophrenia. There is evidence that Cognitive Remediation Therapy, a form of psychological therapy, is effective in improving cognition and functioning but there is still a limited understanding of what influence people's different response to this therapy. A tailored treatment is likely to be more effective because it will adapt to service users' unique characteristics. The investigators are planning a study exploring at the feasibility and acceptability of novel form of Cognitive Remediation Therapy which is personalised (pCRT) to the person individual characteristics. The personalised therapy will consist of task practice using computerized Cognitive Remediation software (i.e. called CIRCuiTS). The knowledge gathered in this work will contribute to develop the next generation of personalised treatment approaches for people with schizophrenia.
    Detailed Description
    Cognitive deficits in people with psychosis have been shown to have negative impact on functional goals including the ability to work and perform daily tasks. Cognitive Remediation Therapy (CRT) is a psychological therapy developed to improve cognitive functions in people with schizophrenia but ultimately with a focus on improving social and functional outcomes. There is evidence that CRT is effective in improving cognition and functioning but there is still a limited understanding of the mechanisms responsible for different treatment responses. This study attempts to fill this gap by developing and testing a new form of CRT, which will personalise therapy elements according to participants' characteristics. The therapy will consist of task practice using a computerised Cognitive Remediation software and supervised activities supported by a therapist to boost functioning. The knowledge gathered in this work will contribute to develop the next generation of personalised treatment approaches for people with schizophrenia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia Schizoaffective
    Keywords
    Cognitive Remediation Therapy CRT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    A case-control study design with pre- and post-therapy assessment.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Personalised Cognitive Remediation Therapy (pCRT)
    Arm Type
    Experimental
    Arm Description
    A case-control study design with pre- and post-therapy assessment, comparing a group of participants with schizophrenia who received standard CRT, with a similar group of participants receiving pCRT.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Remediation Therapy
    Intervention Description
    Cognitive Remediation Therapy (CRT) is a psychological therapy that has been developed with a general immediate focus on improving impaired cognitive domains but ultimately aimed at improving social and functional outcomes.
    Primary Outcome Measure Information:
    Title
    Feasibility of intervention (including acceptance rates, drop outs)
    Description
    Feasibility estimates of delivering the intervention including acceptance rates, drop outs.
    Time Frame
    3 months post baseline assessment
    Secondary Outcome Measure Information:
    Title
    Acceptability of intervention (Satisfaction)
    Description
    Questionnaire of Satisfaction
    Time Frame
    3 months post baseline assessment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: a range of 18-65 years English speaking or with a good knowledge of the language a diagnosis of schizophrenia or schizoaffective disorder according to the DSM- V at least one year contact with mental health services, a deficit (of at least one standard deviation below the mean) in at least one cognitive domain out of these three cognitive domains: memory, executive function and information processing. Exclusion Criteria: Planned medication change Diagnosis of learning disability Presence of cognitive deficits related to organic causes or head injury Primary diagnosis of substance dependence
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Benedetta Seccomandi, PhD student
    Phone
    02078485728
    Email
    benedetta.seccomandi@kcl.ac.uk

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21406461
    Citation
    Wykes T, Huddy V, Cellard C, McGurk SR, Czobor P. A meta-analysis of cognitive remediation for schizophrenia: methodology and effect sizes. Am J Psychiatry. 2011 May;168(5):472-85. doi: 10.1176/appi.ajp.2010.10060855. Epub 2011 Mar 15.
    Results Reference
    result

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    Personalised Cognitive Remediation Therapy (pCRT)

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