NCT03461432

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 12, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

October 31, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 14, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

February 15, 2018

Last Update Submit

August 13, 2018

Conditions

Keywords

Cognitive Remediation Therapy CRT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Acceptability of intervention (Satisfaction)

    3 months post baseline assessment

Study Arms (1)

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.

Behavioral: Cognitive Remediation Therapy

Interventions

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.

Personalised Cognitive Remediation Therapy (pCRT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Benedetta Seccomandi, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A case-control study design with pre- and post-therapy assessment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

March 12, 2018

Study Start

October 31, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

August 14, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share