Cognitive Remediation for First Episode of Psychosis Patients

May 11, 2018 updated by: Emily Revell, University of Manchester

Using Computerised Training to Improve Cognition and Functioning in the First Episode of Psychosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD1 2EP
        • Bradford Early Intervention in Psychosis Service

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion Recognition Task
Time Frame: 10 weeks
The emotion recognition task of the computerised Cambridge neuropsychological test automated battery (CANTAB).
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 weeks and 6 month follow-up
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.
10 weeks and 6 month follow-up
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.
10 weeks and 6 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manchester

Investigators

  • Principal Investigator: Emily Beetschen, University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 14, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 22, 2013

Study Record Updates

Last Update Posted (Actual)

May 14, 2018

Last Update Submitted That Met QC Criteria

May 11, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/NW/0385

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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