Schizophrenia SchizoaffectivepCRTNCT03461432
Personalised Cognitive Remediation Therapy (pCRT)
A study testing Cognitive Remediation Therapy in people with Schizophrenia Schizoaffective, run by King's College London.
Trial summary
Cognitive deficits have been shown to have negative impact on social functioning and functional goals such as ability to work and perform daily tasks in people with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Schizoaffective
- What is being tested?
- Cognitive Remediation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2018to 31 Dec 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a range of 18-65 years
- English speaking or with a good knowledge of the language
- a diagnosis of schizophrenia or schizoaffective disorder according to the DSM- V
- at least one year contact with mental health services,
- a deficit (of at least one standard deviation below the mean) in at least one cognitive domain out of these three cognitive domains: memory, executive function and information processing.
Who cannot join
- Planned medication change
- Diagnosis of learning disability
- Presence of cognitive deficits related to organic causes or head injury
- Primary diagnosis of substance dependence
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Testing the Feasibility and Acceptability of a New Personalised Form of Cognitive Remediation Therapy (pCRT) for People With Psychosis.
Cognitive deficits have been shown to have negative impact on social functioning and functional goals such as ability to work and perform daily tasks in people with schizophrenia. There is evidence that Cognitive Remediation Therapy, a form of psychological therapy, is effective in improving cognition and functioning but there is still a limited understanding of what influence people's different response to this therapy. A tailored treatment is likely to be more effective because it will adapt to service users' unique characteristics.
The investigators are planning a study exploring at the feasibility and acceptability of novel form of Cognitive Remediation Therapy which is personalised (pCRT) to the person individual characteristics. The personalised therapy will consist of task practice using computerized Cognitive Remediation software (i.e. called CIRCuiTS). The knowledge gathered in this work will contribute to develop the next generation of personalised treatment approaches for people with schizophrenia.
Read the detailed description
Cognitive deficits in people with psychosis have been shown to have negative impact on functional goals including the ability to work and perform daily tasks. Cognitive Remediation Therapy (CRT) is a psychological therapy developed to improve cognitive functions in people with schizophrenia but ultimately with a focus on improving social and functional outcomes. There is evidence that CRT is effective in improving cognition and functioning but there is still a limited understanding of the mechanisms responsible for different treatment responses. This study attempts to fill this gap by developing and testing a new form of CRT, which will personalise therapy elements according to participants' characteristics. The therapy will consist of task practice using a computerised Cognitive Remediation software and supervised activities supported by a therapist to boost functioning. The knowledge gathered in this work will contribute to develop the next generation of personalised treatment approaches for people with schizophrenia.
- Conditions
- Schizophrenia Schizoaffective
- Being tested
- Cognitive Remediation Therapy
- Keywords
- Cognitive Remediation Therapy CRT
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation TherapyBehavioural
Cognitive Remediation Therapy (CRT) is a psychological therapy that has been developed with a general immediate focus on improving impaired cognitive domains but ultimately aimed at improving social and functional outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Personalised Cognitive Remediation Therapy (pCRT) | Experimental | A case-control study design with pre- and post-therapy assessment, comparing a group of participants with schizophrenia who received standard CRT, with a similar group of participants receiving pCRT. Receives: Behavioral: Cognitive Remediation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention (including acceptance rates, drop outs)
Feasibility estimates of delivering the intervention including acceptance rates, drop outs.
Measured: 3 months post baseline assessment
Secondary outcomes (1)
Acceptability of intervention (Satisfaction)
Questionnaire of Satisfaction
Measured: 3 months post baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start31 Oct 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia SchizoaffectiveStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- A case-control study design with pre- and post-therapy assessment.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461432
- Sponsor's protocol ID
- 231245
- Acronym
- pCRT
- Status last verified
- Feb 2018
- First submitted
- 15 Feb 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wykes T, Huddy V, Cellard C, McGurk SR, Czobor P. A meta-analysis of cognitive remediation for schizophrenia: methodology and effect sizes. Am J Psychiatry. 2011 May;168(5):472-85. doi: 10.1176/appi.ajp.2010.10060855. Epub 2011 Mar 15.
PubMed 21406461
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility and Acceptability of a New Personalised Form of Cognitive Remediation Therapy (pCRT) for People With Psychosis.
- ClinicalTrials.gov ID
- NCT03461432
- Acronym / sponsor ID
- pCRT / 231245
- Conditions
- Schizophrenia Schizoaffective
- Keywords
- Cognitive Remediation Therapy CRT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 31 Oct 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Mar 2018 (actual)
- 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.
Cognitive deficits have been shown to have negative impact on social functioning and functional goals such as ability to work and perform daily tasks in people with schizophrenia. There is evidence that Cognitive Remediation Therapy, a form of psychological therapy, is effective in improving cognition and functioning but there is still a limited understanding of what influence people's different response to this therapy. A tailored treatment is likely to be more effective because it will adapt to service users' unique characteristics.
The investigators are planning a study exploring at the feasibility and acceptability of novel form of Cognitive Remediation Therapy which is personalised (pCRT) to the person individual characteristics. The personalised therapy will consist of task practice using computerized Cognitive Remediation software (i.e. called CIRCuiTS). The knowledge gathered in this work will contribute to develop the next generation of personalised treatment approaches for people with schizophrenia.
Detailed description
Cognitive deficits in people with psychosis have been shown to have negative impact on functional goals including the ability to work and perform daily tasks. Cognitive Remediation Therapy (CRT) is a psychological therapy developed to improve cognitive functions in people with schizophrenia but ultimately with a focus on improving social and functional outcomes. There is evidence that CRT is effective in improving cognition and functioning but there is still a limited understanding of the mechanisms responsible for different treatment responses. This study attempts to fill this gap by developing and testing a new form of CRT, which will personalise therapy elements according to participants' characteristics. The therapy will consist of task practice using a computerised Cognitive Remediation software and supervised activities supported by a therapist to boost functioning. The knowledge gathered in this work will contribute to develop the next generation of personalised treatment approaches for people with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A case-control study design with pre- and post-therapy assessment.
| Arm | Type | Receives |
|---|---|---|
| Personalised Cognitive Remediation Therapy (pCRT) | Experimental | Behavioral: Cognitive Remediation TherapyA case-control study design with pre- and post-therapy assessment, comparing a group of participants with schizophrenia who received standard CRT, with a similar group of participants receiving pCRT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a range of 18-65 years
- English speaking or with a good knowledge of the language
- a diagnosis of schizophrenia or schizoaffective disorder according to the DSM- V
- at least one year contact with mental health services,
- a deficit (of at least one standard deviation below the mean) in at least one cognitive domain out of these three cognitive domains: memory, executive function and information processing.
Key exclusion criteria (4 listed)
- Planned medication change
- Diagnosis of learning disability
- Presence of cognitive deficits related to organic causes or head injury
- Primary diagnosis of substance dependence
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 Remediation TherapyCognitive Remediation Therapy (CRT) is a psychological therapy that has been developed with a general immediate focus on improving impaired cognitive domains but ultimately aimed at improving social and functional outcomes. | Behavioural | Personalised Cognitive Remediation Therapy (pCRT) |
Primary outcome
Feasibility of intervention (including acceptance rates, drop outs)
Time frame: 3 months post baseline assessment
Feasibility estimates of delivering the intervention including acceptance rates, drop outs.
1 secondary outcome
Acceptability of intervention (Satisfaction)
Time frame: 3 months post baseline assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Results publication: PubMed 21406461Wykes T, Huddy V, Cellard C, McGurk SR, Czobor P. A meta-analysis of cognitive remediation for schizophrenia: methodology and effect sizes. Am J Psychiatry. 2011 May;168(5):472-85. doi: 10.1176/appi.ajp.2010.10060855. Epub 2011 Mar 15.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation Therapy in people with Schizophrenia Schizoaffective, run by King's College London.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedetta Seccomandi, PhD student (02078485728, benedetta.seccomandi@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (including acceptance rates, drop outs) (time frame: 3 months post baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03461432, which also lists 1 linked publication.
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 Aug 2018.