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Cognitive Remediation for First Episode of Psychosis Patients

Primary Purpose

Psychosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive remediation
Social cognition training
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Cognitive remediation, Social cognition training, First episode psychosis, Schizophrenia

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bradford Early Intervention in Psychosis Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive remediation plus social cognition training

Cognitive remediation alone

Arm Description

A combined intervention of 60 minutes of computerised cognitive remediation and 30 minutes of computerised social cognition training.

An active control condition consisting of 60 minutes of computerised cognitive remediation and 30 minutes of free computer time.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CANTAB schizophrenia battery
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)
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)
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.

Full Information

First Posted
October 14, 2013
Last Updated
May 11, 2018
Sponsor
University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT01967420
Brief Title
Cognitive Remediation for First Episode of Psychosis Patients
Official Title
Using Computerised Training to Improve Cognition and Functioning in the First Episode of Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
Cognitive remediation, Social cognition training, First episode psychosis, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive remediation plus social cognition training
Arm Type
Experimental
Arm Description
A combined intervention of 60 minutes of computerised cognitive remediation and 30 minutes of computerised social cognition training.
Arm Title
Cognitive remediation alone
Arm Type
Active Comparator
Arm Description
An active control condition consisting of 60 minutes of computerised cognitive remediation and 30 minutes of free computer time.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive remediation
Other Intervention Name(s)
CIRCuiTS, cognitive training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social cognition training
Other Intervention Name(s)
Mind reading - an interactive guide to emotions
Intervention Description
The social cognition training is a computerised program which aims to improve emotion recognition through a variety of lessons and games.
Primary Outcome Measure Information:
Title
Emotion Recognition Task
Description
The emotion recognition task of the computerised Cambridge neuropsychological test automated battery (CANTAB).
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
CANTAB schizophrenia battery
Description
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).
Time Frame
10 weeks and 6 month follow-up
Title
Specific levels of functioning scale (SLOF)
Description
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.
Time Frame
10 weeks and 6 month follow-up
Title
Personal and Social Performance Scale (PSP)
Description
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.
Time Frame
10 weeks and 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Beetschen
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bradford Early Intervention in Psychosis Service
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD1 2EP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Cognitive Remediation for First Episode of Psychosis Patients

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