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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

Tracking Information
First Submitted Date  ICMJE October 14, 2013
First Posted Date  ICMJE October 22, 2013
Last Update Posted Date May 14, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2013)
Emotion Recognition Task [ Time Frame: 10 weeks ]
The emotion recognition task of the computerised Cambridge neuropsychological test automated battery (CANTAB).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01967420 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2013)
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Remediation for First Episode of Psychosis Patients
Official Title  ICMJE Using Computerised Training to Improve Cognition and Functioning in the First Episode of Psychosis
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Psychosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Cognitive remediation
    • Behavioral: Social cognition training
  • Active Comparator: Cognitive remediation alone
    An active control condition consisting of 60 minutes of computerised cognitive remediation and 30 minutes of free computer time.
    Intervention: Behavioral: Cognitive remediation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2016)
40
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2013)
48
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01967420
Other Study ID Numbers  ICMJE 13/NW/0385
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emily Revell, University of Manchester
Study Sponsor  ICMJE University of Manchester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emily Beetschen University of Manchester
PRS Account University of Manchester
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP