Clinical trial NCT01967420: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: Cognitive remediation
Social cognition training
First episode psychosis
Schizophrenia
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Emotion Recognition Task
timeFrame: 10 weeks
Secondary outcomes:
measure: CANTAB schizophrenia battery
timeFrame: 10 weeks and 6 month follow-up
measure: Specific levels of functioning scale (SLOF)
timeFrame: 10 weeks and 6 month follow-up
measure: Personal and Social Performance Scale (PSP)
timeFrame: 10 weeks and 6 month follow-up
Other outcomes:
Locations:
city: Bradford
country: United Kingdom
facility: Bradford Early Intervention in Psychosis Service
state: West Yorkshire
Study officials:
affiliation: University of Manchester
name: Emily Beetschen
role: PRINCIPAL_INVESTIGATOR
References: