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Cognitive Remediation for First Episode of Psychosis Patients

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ClinicalTrials.gov Identifier: NCT01967420
Recruitment Status : Completed
First Posted : October 22, 2013
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Emily Revell, University of Manchester

Brief Summary:
This study aims to look at the effectiveness of a combination of cognitive remediation and social cognition training to improve cognition and functioning when compared to cognitive remediation alone. The target population will be those who are experiencing their first episode of psychosis.

Condition or disease Intervention/treatment Phase
Psychosis Behavioral: Cognitive remediation Behavioral: Social cognition training Not Applicable

Detailed Description:

A first episode of psychosis is defined as the first experience of positive symptoms, such as hallucinations and delusions, and the behaviour that accompanies it. This is associated with problems in many areas of cognition; the ability to acquire knowledge and understanding. These cognitive symptoms have been found to have a large impact on daily functioning (e.g. accessing education or employment and maintaining relationships) and cannot effectively be treated with medication. Cognitive remediation (CR) is a therapy that aims to improve cognition and, through generalisation of this, improve daily functioning and quality of life. Although it is an area of deficit, social cognition, the ability to perceive and understand emotional states, is often not targeted in cognitive remediation. However, interventions which have focused on providing social cognition training (SCT) alongside CR have shown large improvements in daily functioning.

This study aims to look at the effectiveness of a combination of CR and SCT to improve cognition and functioning when compared to CR alone. The target population will be those who are experiencing their first episode of psychosis. Participants will be recruited from an Early Intervention in Psychosis service which is an NHS service set up to provide rapid treatment for those experiencing psychosis.

Participants will take part in a ten week CR or CR+SCT intervention which will consist of spending 90 minutes a week in a small group setting working through a series of computer games which aim to improve cognition. Interviews and questionnaires regarding daily functioning, cognition, quality of life and symptoms will be used before and after the intervention. Participants will be asked to attend follow-up interviews 6 months after the intervention has ended to complete the measures again to see if any beneficial effects have lasted.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Using Computerised Training to Improve Cognition and Functioning in the First Episode of Psychosis
Study Start Date : August 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive remediation plus social cognition training
A combined intervention of 60 minutes of computerised cognitive remediation and 30 minutes of computerised social cognition training.
Behavioral: Cognitive remediation
CIRCuiTS is a computerised cognitive remediation program which consists of tasks to improve cognition, the use of strategy training and the teaching of generalisable community functioning skills.
Other Names:
  • CIRCuiTS
  • cognitive training

Behavioral: Social cognition training
The social cognition training is a computerised program which aims to improve emotion recognition through a variety of lessons and games.
Other Name: Mind reading - an interactive guide to emotions

Active Comparator: Cognitive remediation alone
An active control condition consisting of 60 minutes of computerised cognitive remediation and 30 minutes of free computer time.
Behavioral: Cognitive remediation
CIRCuiTS is a computerised cognitive remediation program which consists of tasks to improve cognition, the use of strategy training and the teaching of generalisable community functioning skills.
Other Names:
  • CIRCuiTS
  • cognitive training




Primary Outcome Measures :
  1. Emotion Recognition Task [ Time Frame: 10 weeks ]
    The emotion recognition task of the computerised Cambridge neuropsychological test automated battery (CANTAB).


Secondary Outcome Measures :
  1. CANTAB schizophrenia battery [ Time Frame: 10 weeks and 6 month follow-up ]
    Additional computerised neuropsychological tests from the CANTAB schizophrenia battery will be used. These are the rapid visual information processing task (RVP), the spatial working memory task (SWM), the paired associates learning task (PAL), one touch stockings of Cambridge task (OTS) and the intra-extra dimensional set shift task (IED).

  2. Specific levels of functioning scale (SLOF) [ Time Frame: 10 weeks and 6 month follow-up ]
    SLOF is an observer-rated set of 6 domains of functioning where ratings are made on 5-point Likert scales based on how often a particular behaviour occurs or how much help is required to perform certain tasks. The 6 domains are: physical functioning, personal care skills, interpersonal relationships, social acceptability, activities and work skills, the final four of which will be used in this study. This will be completed with the participant's primary care team and verified with the participant.

  3. Personal and Social Performance Scale (PSP) [ Time Frame: 10 weeks and 6 month follow-up ]
    An additional measure of functioning, the PSP will be added on to the end of the SLOF. The PSP addresses 4 domains: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviours. It is scored on a 1-100 scale. This is a validated and reliable measure of functioning with high test-retest reliability. It will be completed by a member of the participant's care team.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-affective psychosis
  • Premorbid IQ of over 70
  • A service user of the early intervention service
  • Aged 18 or over (up to the age of 35 which is the limit for the early intervention service)
  • Psychiatrically stable enough to attend to completion (no hospitalisations or medication changes in last 4 weeks)

Exclusion Criteria:

  • Active substance dependency
  • History of severe head injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967420


Locations
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United Kingdom
Bradford Early Intervention in Psychosis Service
Bradford, West Yorkshire, United Kingdom, BD1 2EP
Sponsors and Collaborators
University of Manchester
Investigators
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Principal Investigator: Emily Beetschen University of Manchester

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Responsible Party: Emily Revell, Postgraduate Researcher, University of Manchester
ClinicalTrials.gov Identifier: NCT01967420     History of Changes
Other Study ID Numbers: 13/NW/0385
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Keywords provided by Emily Revell, University of Manchester:
Cognitive remediation
Social cognition training
First episode psychosis
Schizophrenia

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders