Overview

This trial is active, not recruiting.

Condition psychosis
Treatments cognitive remediation, social cognition training
Sponsor University of Manchester
Start date August 2013
End date July 2015
Trial size 40 participants
Trial identifier NCT01967420, 13/NW/0385

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (caregiver)
Primary purpose treatment
Arm
(Experimental)
A combined intervention of 60 minutes of computerised cognitive remediation and 30 minutes of computerised social cognition training.
cognitive remediation CIRCuiTS
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 Mind reading - an interactive guide to emotions
The social cognition training is a computerised program which aims to improve emotion recognition through a variety of lessons and games.
(Active Comparator)
An active control condition consisting of 60 minutes of computerised cognitive remediation and 30 minutes of free computer time.
cognitive remediation CIRCuiTS
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.

Primary Outcomes

Measure
Emotion Recognition Task
time frame: 10 weeks

Secondary Outcomes

Measure
CANTAB schizophrenia battery
time frame: 10 weeks and 6 month follow-up
Specific levels of functioning scale (SLOF)
time frame: 10 weeks and 6 month follow-up
Personal and Social Performance Scale (PSP)
time frame: 10 weeks and 6 month follow-up

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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

Additional Information

Official title Using Computerised Training to Improve Cognition and Functioning in the First Episode of Psychosis
Principal investigator Emily Beetschen
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Manchester.