CClinicalTrials.gg
Status unknownNCT01903707Updated Dec 5, 2014

Cognitive Remediation in Schizophrenia

An interventional study of Cognitive Remediation Therapy and Placebo comparator in Schizophrenia and Psychosis, sponsored by University of Dublin, Trinity College. Status unknown at 1 site in Ireland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-05.

Sponsored by University of Dublin, Trinity College · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

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 schizophrenia. Pre and Post neuropsychological assessment and Magnetic Resonance Imagery (MRI) will be used to determine the effects of CR training on

  1. Neuropsychological performance
  2. Brain Structure using voxel-based morphometry (VBM)
  3. Brain function using functional MRI (fMRI)
  4. Social and occupational functioning

The cognitive remediation intervention is a computerised programme whose training level is dynamically varied to suit participants individual ability level. Motivation to learn and generalization to real world function are a particular focus of the intervention and are supported with ongoing therapist interaction in addition to personal training.

02

Conditions studied

  • Schizophrenia
  • Psychosis

Keywords

  • Schizophrenia
  • Psychosis
  • Cognitive deficits
03

In context

Schizophrenia

3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.

This study's planned enrollment of 80 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

University of Dublin, Trinity College is the lead sponsor of 72 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • History of head injury resulting in loss of consciousness
  • Substance misuse in the last 3 months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Cognitive Remediation Therapy

    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

  • OtherCognitive Remediation Therapy

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

    Also known as: CRT

  • OtherPlacebo comparator

    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

06

What researchers measure

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.

    Time frame: Directly following study treatment period

Secondary outcomes

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

    A battery of neuropsychological tests will be used at baseline and the same tests used at 3 months post 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.

    Time frame: 3 to 6 months post study treatment period

  2. Changes from baseline in brain activation during working memory testing

    Changes from baseline in brain activation during working memory testing will be measured using fMRI

    Time frame: Directly post study treatment period

  3. Change from baseline in grey matter volume

    Changes in grey matter volume from baseline will be measured at 3 months post intervention using voxel based morphometry.

    Time frame: Directly following study treatment period

Other outcomes

  1. Changes in social and occupational functioning

    Social and occupational function will be measured at baseline and the same tests used directly following intervention. Standardised measures will be used including ILS (Independent Living Scales) and the UCSD performance skills assessment brief version(UPSA-B)

    Time frame: Directly following study treatment period

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

    Social and occupational function will be measured at baseline and the same tests used directly following intervention. Standardised measures will be used including ILS (Independent Living Scales) and the UCSD performance skills assessment brief version(UPSA-B)

    Time frame: 3 to 6 months post study treatment period

07

Study locations

1 of 1 sites recruiting
  • Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.
    Dublin, 8, Ireland
    • April H Hargreaves, PhD · Contact · hargrea@tcd.ie · 35318962624
    • Rachael Dillon, BSc · Contact · radillon@tcd.ie · 35318962315
    • Gary J Donohue, DClin Psych PhD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01903707
Lead sponsor
University of Dublin, Trinity College
Collaborators
Health Research Board, Ireland
Responsible party
Gary Donohoe (Associate Professor, University of Dublin, Trinity College) — Principal investigator
First posted
Jul 19, 2013
Start date
May 2013
Primary completion
Jun 2015 (estimated)
Completion
Oct 2015 (estimated)
Last update
Dec 5, 2014

Study contacts

April H Hargreaves, PhD
Contact
hargrea@tcd.ie
353-1-8962465
Rachael Dillon, Bsc
Contact
radillon@tcd.ie
353-1-8962315
Gary J Donoghoe, DClin Psych PhD
principal investigator · Trinity College Dublin, Ireland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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