SchizophreniaNCT01903707
Cognitive Remediation in Schizophrenia
A study testing Cognitive Remediation Therapy in people with Schizophrenia and Psychosis, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychosis
- What is being tested?
- Cognitive Remediation Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIreland
- Study dates
- May 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Schizophrenia
- History of Psychosis
- Subjective difficulties with memory or concentration
- Aged 18-60 Years
Who cannot join
- History of head injury resulting in loss of consciousness
- Substance misuse in the last 3 months
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Department of Psychiatry, Trinity Centre for Health Sciences, St James Hospital, James St.
Dublin, Dublin, 8
April H Hargreaves, PhD, 35318962624, hargrea@tcd.ie
Rachael Dillon, BSc, 35318962315, radillon@tcd.ie
About this study
Official title: Cognitive Remediation in Schizophrenia: Effects on Brain Structure, Brain Function and Social Outcome.
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
- Neuropsychological performance
- Brain Structure using voxel-based morphometry (VBM)
- Brain function using functional MRI (fMRI)
- 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.
- Conditions
- Schizophrenia, Psychosis
- Being tested
- Cognitive Remediation Therapy, Placebo comparator
- Keywords
- Schizophrenia, Psychosis, Cognitive deficits
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation TherapyOther
Also called CRT
Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks
Placebo comparatorOther
Also called No intervention
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cognitive Remediation Therapy |
| Placebo Comparator | Placebo comparator | Participants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training. Receives: Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Directly following study treatment period
Secondary outcomes (3)
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.
Measured: 3 to 6 months post study treatment period
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
Measured: Directly post study treatment period
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.
Measured: Directly following study treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Principal investigator, Gary Donohoe, University of Dublin, Trinity College
- Investigators
- Gary J Donoghoe, DClin Psych PhD, Principal investigator, Trinity College Dublin, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903707
- Sponsor's protocol ID
- CRT001
- Status last verified
- Dec 2014
- First submitted
- 2 Jul 2013
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation in Schizophrenia: Effects on Brain Structure, Brain Function and Social Outcome.
- ClinicalTrials.gov ID
- NCT01903707
- Acronym / sponsor ID
- CRT001
- Conditions
- Schizophrenia, Psychosis
- Keywords
- Schizophrenia, Psychosis, Cognitive deficits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- May 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Neuropsychological performance
- Brain Structure using voxel-based morphometry (VBM)
- Brain function using functional MRI (fMRI)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation Therapy | Experimental | Other: Cognitive Remediation TherapyParticipants 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. |
| Placebo Comparator | Placebo comparator | Other: Placebo comparatorParticipants will meet therapist once per week but will not undertake the Computerized Cognitive remediation training. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Schizophrenia
- History of Psychosis
- Subjective difficulties with memory or concentration
- Aged 18-60 Years
Key exclusion criteria (2 listed)
- History of head injury resulting in loss of consciousness
- Substance misuse in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Remediation TherapyAlso: CRTComputerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks | Other | Cognitive Remediation Therapy |
| Placebo comparatorAlso: No interventionParticipant 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). | Other | Placebo Comparator |
Primary outcome
Change from baseline neuropsychological performance
Time frame: Directly following study treatment period
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.
3 secondary outcomes
Change from baseline neuropsychological performance at 3 to 6 months post intervention
Time frame: 3 to 6 months post study treatment period
Changes from baseline in brain activation during working memory testing
Time frame: Directly post study treatment period
Change from baseline in grey matter volume
Time frame: Directly following study treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
- Website of the neuropsychiatric genetics group at Trinity College Dublin, IrelandLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary J Donoghoe, DClin Psych PhD principal investigator
Trinity College Dublin, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation Therapy in people with Schizophrenia and Psychosis, run by University of Dublin, Trinity College at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact April H Hargreaves, PhD (353-1-8962465, hargrea@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline neuropsychological performance (time frame: Directly following study treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.