PsychosisNCT01967420
Cognitive Remediation for First Episode of Psychosis Patients
A study testing Cognitive remediation and Social cognition training in people with Psychosis, run by University of Manchester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Cognitive remediation and Social cognition training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Active substance dependency
- History of severe head injury
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bradford Early Intervention in Psychosis Service
Bradford, West Yorkshire, BD1 2EP
About this study
Official title: Using Computerised Training to Improve Cognition and Functioning in the First Episode of Psychosis
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.
Read the 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
- Being tested
- Cognitive remediation, Social cognition training
- Keywords
- Cognitive remediation, Social cognition training, First episode psychosis, Schizophrenia
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediationBehavioural
Also called CIRCuiTS, cognitive training
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 trainingBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive remediation plus social cognition training | Experimental | A combined intervention of 60 minutes of computerised cognitive remediation and 30 minutes of computerised social cognition training. Receives: Behavioral: Cognitive remediation; Behavioral: Social cognition training |
| Cognitive remediation alone | Active comparator | An active control condition consisting of 60 minutes of computerised cognitive remediation and 30 minutes of free computer time. Receives: Behavioral: Cognitive remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotion Recognition Task
The emotion recognition task of the computerised Cambridge neuropsychological test automated battery (CANTAB).
Measured: 10 weeks
Secondary outcomes (3)
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).
Measured: 10 weeks and 6 month follow-up
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.
Measured: 10 weeks and 6 month follow-up
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.
Measured: 10 weeks and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily Revell, University of Manchester
- Investigators
- Emily Beetschen, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967420
- Sponsor's protocol ID
- 13/NW/0385
- Status last verified
- May 2018
- First submitted
- 14 Oct 2013
- Last updated
- 14 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Computerised Training to Improve Cognition and Functioning in the First Episode of Psychosis
- ClinicalTrials.gov ID
- NCT01967420
- Acronym / sponsor ID
- 13/NW/0385
- Conditions
- Psychosis
- Keywords
- Cognitive remediation, Social cognition training, First episode psychosis, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive remediation plus social cognition training | Experimental | Behavioral: Cognitive remediation, Behavioral: Social cognition trainingA combined intervention of 60 minutes of computerised cognitive remediation and 30 minutes of computerised social cognition training. |
| Cognitive remediation alone | Active comparator | Behavioral: Cognitive remediationAn active control condition consisting of 60 minutes of computerised cognitive remediation and 30 minutes of free computer time. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- Active substance dependency
- History of severe head injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive remediationAlso: CIRCuiTS, cognitive trainingCIRCuiTS 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. | Behavioural | Cognitive remediation alone, Cognitive remediation plus social cognition training |
| Social cognition trainingAlso: Mind reading - an interactive guide to emotionsThe social cognition training is a computerised program which aims to improve emotion recognition through a variety of lessons and games. | Behavioural | Cognitive remediation plus social cognition training |
Primary outcome
Emotion Recognition Task
Time frame: 10 weeks
The emotion recognition task of the computerised Cambridge neuropsychological test automated battery (CANTAB).
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Beetschen principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation and Social cognition training in people with Psychosis, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Recognition Task (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.