Personalised Cognitive Remediation Therapy (pCRT) (pCRT)

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia Schizoaffective
• Intervention / Treatment: Behavioral: Cognitive Remediation Therapy

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalised Cognitive Remediation Therapy (pCRT); 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.	Behavioral: Cognitive Remediation Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of intervention (including acceptance rates, drop outs)	Feasibility estimates of delivering the intervention including acceptance rates, drop outs.	3 months post baseline assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of intervention (Satisfaction)	Questionnaire of Satisfaction	3 months post baseline assessment

Collaborators and Investigators

• Sponsor: King's College London

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 31, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: March 8, 2018
• First Posted (Actual): March 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Cognitive Remediation Therapy CRT
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: 231245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No