NCT01967420

Brief Summary

This study aims to look at the effectiveness of a combination of cognitive remediation and social cognition training to improve cognition and functioning when compared to cognitive remediation alone. The target population will be those who are experiencing their first episode of psychosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 22, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

October 14, 2013

Last Update Submit

May 11, 2018

Conditions

Psychosis

Keywords

Cognitive remediationSocial cognition trainingFirst episode psychosisSchizophrenia

Outcome Measures

Primary Outcomes (1)

  • Emotion Recognition Task

    The emotion recognition task of the computerised Cambridge neuropsychological test automated battery (CANTAB).

    10 weeks

Secondary Outcomes (3)

  • CANTAB schizophrenia battery

    10 weeks and 6 month follow-up

  • Specific levels of functioning scale (SLOF)

    10 weeks and 6 month follow-up

  • Personal and Social Performance Scale (PSP)

    10 weeks and 6 month follow-up

Study Arms (2)

Cognitive remediation plus social cognition training

EXPERIMENTAL

A combined intervention of 60 minutes of computerised cognitive remediation and 30 minutes of computerised social cognition training.

Behavioral: Cognitive remediationBehavioral: Social cognition training

Cognitive remediation alone

ACTIVE COMPARATOR

An active control condition consisting of 60 minutes of computerised cognitive remediation and 30 minutes of free computer time.

Behavioral: Cognitive remediation

Interventions

Cognitive remediationBEHAVIORAL

CIRCuiTS is a computerised cognitive remediation program which consists of tasks to improve cognition, the use of strategy training and the teaching of generalisable community functioning skills.

Also known as: CIRCuiTS, cognitive training
Cognitive remediation aloneCognitive remediation plus social cognition training
Social cognition trainingBEHAVIORAL

The social cognition training is a computerised program which aims to improve emotion recognition through a variety of lessons and games.

Also known as: Mind reading - an interactive guide to emotions
Cognitive remediation plus social cognition training

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non-affective psychosis
  • Premorbid IQ of over 70
  • A service user of the early intervention service
  • Aged 18 or over (up to the age of 35 which is the limit for the early intervention service)
  • Psychiatrically stable enough to attend to completion (no hospitalisations or medication changes in last 4 weeks)

You may not qualify if:

  • Active substance dependency
  • History of severe head injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bradford Early Intervention in Psychosis Service

Bradford, West Yorkshire, BD1 2EP, United Kingdom

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Interventions

Cognitive RemediationGene Regulatory NetworksCognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesRegulatory Sequences, Nucleic AcidBase SequenceGenetic StructuresGenetic PhenomenaNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Emily Beetschen

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Researcher

Study Record Dates

First Submitted

October 14, 2013

First Posted

October 22, 2013

Study Start

August 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2016

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations

GB(1)