NCT01903707

Brief Summary

The aim of this project is to undertake a randomized placebo controlled trial of cognitive remediation therapy (CRT) that focuses on working memory training in a sample of community based patients with chronic schizophrenia or other psychoses. Cognitive deficits are a problem for many people with schizophrenia. This study will use computerized cognitive remediation training (which the participant can carry out at home) over a period of a few months.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

2.1 years

First QC Date

July 2, 2013

Last Update Submit

December 4, 2014

Conditions

SchizophreniaPsychosis

Keywords

SchizophreniaPsychosisCognitive deficits

Outcome Measures

Primary Outcomes (1)

  • Change from baseline neuropsychological performance

    A battery of neuropsychological tests will be used at baseline and the same tests used directly after the intervention to measure changes in attention and memory. Tests include Wechsler Adult intelligence scale-III, Wechsler Memory Scale-III, Stroop test, Wisconsin card sorting task and measures of spatial working memory.

    Directly following study treatment period

Secondary Outcomes (3)

  • Change from baseline neuropsychological performance at 3 to 6 months post intervention

    3 to 6 months post study treatment period

  • Changes from baseline in brain activation during working memory testing

    Directly post study treatment period

  • Change from baseline in grey matter volume

    Directly following study treatment period

Other Outcomes (2)

  • Changes in social and occupational functioning

    Directly following study treatment period

  • Change from baseline in social and occupational functioning 3 to 6 months post intervention

    3 to 6 months post study treatment period

Study Arms (2)

Cognitive Remediation Therapy

EXPERIMENTAL

Participants will undertake approximately 30 minutes of computerized CRT training for 8 weeks, 5 days per week. They will meet a therapist once per week to discuss any difficulties, help motivation.

Other: Cognitive Remediation Therapy

Placebo Comparator

PLACEBO COMPARATOR

Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training.

Other: Placebo comparator

Interventions

Cognitive Remediation TherapyOTHER

Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks

Also known as: CRT
Cognitive Remediation Therapy
Placebo comparatorOTHER

Participant meets the therapist once per week but does not carry out the CRT intervention. (Participants are subsequently offered the chance to carry out the CRT intervention post study if they so wish).

Also known as: No intervention
Placebo Comparator

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Schizophrenia
  • History of Psychosis
  • Subjective difficulties with memory or concentration
  • Aged 18-60 Years

You may not qualify if:

  • History of head injury resulting in loss of consciousness
  • Substance misuse in the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.

Dublin, Dublin, 8, Ireland

RECRUITING

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersCognition Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNeurocognitive Disorders

Study Officials

  • Gary J Donoghoe, DClin Psych PhD

    Trinity College Dublin, Ireland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

April H Hargreaves, PhD

CONTACT

353-1-8962465hargrea@tcd.ie

Rachael Dillon, Bsc

CONTACT

353-1-8962315radillon@tcd.ie

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 19, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

IE(1)