Clinical trial NCT03461432: Personalised Cognitive Remediation Therapy (pCRT)
Official title: Testing the Feasibility and Acceptability of a New Personalised Form of Cognitive Remediation Therapy (pCRT) for People With Psychosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia Schizoaffective
Keywords: Cognitive Remediation Therapy CRT
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A case-control study design with pre- and post-therapy assessment.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Planned medication change
* Diagnosis of learning disability
* Presence of cognitive deficits related to organic causes or head injury
* Primary diagnosis of substance dependence

Primary outcomes:
measure: Feasibility of intervention (including acceptance rates, drop outs)
timeFrame: 3 months post baseline assessment
Secondary outcomes:
measure: Acceptability of intervention (Satisfaction)
timeFrame: 3 months post baseline assessment
Other outcomes:
Locations:
Study officials:
References:
citation: 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.