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Completed

NCT Number: NCT01967420

Cognitive Remediation for First Episode of Psychosis Patients

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.

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Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bradford Early Intervention in Psychosis Service

Bradford, West Yorkshire, BD1 2EP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Remediation

Behavioral

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

Social Cognition Training

Behavioral

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

Primary outcomes

  1. Emotion Recognition Task

    Time frame: 10 weeks

    The emotion recognition task of the computerised Cambridge neuropsychological test automated battery (CANTAB).

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Oct 22, 2013
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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