Cognitive Remediation for First Episode of Psychosis Patients

NCT ID: NCT01967420

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-07-31

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.

Conditions

Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive remediation plus social cognition training

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

Group Type: EXPERIMENTAL

Cognitive remediation

Intervention Type: 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.

Social cognition training

Intervention Type: BEHAVIORAL

The social cognition training is a computerised program which aims to improve emotion recognition through a variety of lessons and games.

Cognitive remediation alone

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

Group Type: ACTIVE_COMPARATOR

Cognitive remediation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CIRCuiTS; cognitive training; Mind reading - an interactive guide to emotions

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manchester

OTHER

Sponsor Role: lead

Responsible Party

Emily Revell

Postgraduate Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily Beetschen

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

Bradford Early Intervention in Psychosis Service

Bradford, West Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

13/NW/0385

Identifier Type: -

Identifier Source: org_study_id