Personalised Cognitive Remediation Therapy (pCRT) (pCRT)
Primary Purpose
Schizophrenia Schizoaffective
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Remediation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia Schizoaffective focused on measuring Cognitive Remediation Therapy CRT
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Personalised Cognitive Remediation Therapy (pCRT)
Arm Description
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.
Outcomes
Primary Outcome Measures
Feasibility of intervention (including acceptance rates, drop outs)
Feasibility estimates of delivering the intervention including acceptance rates, drop outs.
Secondary Outcome Measures
Acceptability of intervention (Satisfaction)
Questionnaire of Satisfaction
Full Information
NCT ID
NCT03461432
First Posted
February 15, 2018
Last Updated
August 13, 2018
Sponsor
King's College London
1. Study Identification
Unique Protocol Identification Number
NCT03461432
Brief Title
Personalised Cognitive Remediation Therapy (pCRT)
Acronym
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Schizoaffective
Keywords
Cognitive Remediation Therapy CRT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A case-control study design with pre- and post-therapy assessment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Personalised Cognitive Remediation Therapy (pCRT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of intervention (including acceptance rates, drop outs)
Description
Feasibility estimates of delivering the intervention including acceptance rates, drop outs.
Time Frame
3 months post baseline assessment
Secondary Outcome Measure Information:
Title
Acceptability of intervention (Satisfaction)
Description
Questionnaire of Satisfaction
Time Frame
3 months post baseline assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benedetta Seccomandi, PhD student
Phone
02078485728
Email
benedetta.seccomandi@kcl.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21406461
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.
Results Reference
result
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Personalised Cognitive Remediation Therapy (pCRT)
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