Psychotic DisordersNCT03024203
A Comparison of Cognitive Training Approaches in Psychotic Disorders
A study testing Cognitive Remediation - Executive Training and Cognitive Remediation - Perceptual Training in people with Psychotic Disorders, run by Queen's University at 1 site in Canada.
Trial summary
Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for individuals with psychosis, however, there is no gold standard method of cognitive remediation available. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Cognitive Remediation - Executive Training and Cognitive Remediation - Perceptual Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Mar 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- psychotic disorder
- No previous cognitive remediation in past 6 months
Who cannot join
- Brain injury
- Substance abuse
- Neurocognitive disorder
- Developmental Disability
Trial locations and contacts
1 site in 1 country.
About this study
Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for individuals with psychosis, however, there is no gold standard method of cognitive remediation available. Cognitive training refers to the training component of CR in which people practice computerized exercises that train specific cognitive abilities. There is no agreed upon approach within the field as to the type of training that is most effective with some studies, training higher level cognitive abilities, some training perceptual abilities, and others training general cognitive skills. This study will directly compare two competing methods of cognitive training on measures of neurophysiology, neurocognition, functional competence, and real-world functional performance.
- Conditions
- Psychotic Disorders
- Being tested
- Cognitive Remediation - Executive Training, Cognitive Remediation - Perceptual Training
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation - Executive TrainingBehavioural
Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as memory, and problem solving ability.
Cognitive Remediation - Perceptual TrainingBehavioural
Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as attention, and processing speed.
| Study group | Role | What they receive |
|---|---|---|
| Executive Training | Experimental | Executive Training (ET) involves training on computerized cognitive exercises that have graded increases in difficulty so that the participant is always challenged. A therapist will be in the room with participants to address any difficulties with the program and facilitate generation of strategies. ET will be delivered in both individual and group settings. Receives: Behavioral: Cognitive Remediation - Executive Training |
| Perceptual Training | Experimental | Perceptual Training (PT) involves training on computerized cognitive exercises that have graded increases in difficulty so that the participant is always challenged. A therapist will be in the room with participants to address any difficulties with the program and facilitate generation of strategies. PT will be delivered in both individual and group settings. Receives: Behavioral: Cognitive Remediation - Perceptual Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline
Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks
Measured: Post-treatment (within 2 weeks following the end of treatment)
Secondary outcomes (7)
Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline
The MCCB is the gold standard cognitive assessment for schizophrenia research
Measured: Post-treatment (within 2 weeks following the end of treatment)
Change in Neurophysiology - EEG from Baseline
Alpha and Theta band synchronization, p300, mismatch negativity
Measured: Post-treatment (within 2 weeks following the end of treatment)
Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline
Performance based measure of real life functional skills using role-play
Measured: Post-treatment (within 2 weeks following the end of treatment)
Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline
Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks
Measured: Follow-Up (3 months after the end of treatment)
Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline
The MCCB is the gold standard cognitive assessment for schizophrenia research
Measured: Follow-Up (3 months after the end of treatment)
Change in Neurophysiology - EEG from Baseline
Alpha and Theta band synchronization, p300, mismatch negativity
Measured: Follow-Up (3 months after the end of treatment)
Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline
Performance based measure of real life functional skills using role-play
Measured: Follow-Up (3 months after the end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startAug 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christopher Bowie, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024203
- Sponsor's protocol ID
- PSYC-173-16
- Status last verified
- Nov 2018
- First submitted
- 27 Oct 2016
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Best MW, Milanovic M, Iftene F, Bowie CR. A Randomized Controlled Trial of Executive Functioning Training Compared With Perceptual Training for Schizophrenia Spectrum Disorders: Effects on Neurophysiology, Neurocognition, and Functioning. Am J Psychiatry. 2019 Apr 1;176(4):297-306. doi: 10.1176/appi.ajp.2018.18070849. Epub 2019 Mar 8.
PubMed 30845819
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Cognitive Training Approaches in Psychotic Disorders
- ClinicalTrials.gov ID
- NCT03024203
- Acronym / sponsor ID
- PSYC-173-16
- Conditions
- Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 18 Jan 2017 (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.
Cognitive remediation (CR) is the best treatment to improve neurocognitive abilities for individuals with psychosis, however, there is no gold standard method of cognitive remediation available. Cognitive training refers to the training component of CR in which people practice computerized exercises that train specific cognitive abilities. There is no agreed upon approach within the field as to the type of training that is most effective with some studies, training higher level cognitive abilities, some training perceptual abilities, and others training general cognitive skills. This study will directly compare two competing methods of cognitive training on measures of neurophysiology, neurocognition, functional competence, and real-world functional performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Executive Training | Experimental | Behavioral: Cognitive Remediation - Executive TrainingExecutive Training (ET) involves training on computerized cognitive exercises that have graded increases in difficulty so that the participant is always challenged. A therapist will be in the room with participants to address any difficulties with the program and facilitate generation of strategies. ET will be delivered in both individual and group settings. |
| Perceptual Training | Experimental | Behavioral: Cognitive Remediation - Perceptual TrainingPerceptual Training (PT) involves training on computerized cognitive exercises that have graded increases in difficulty so that the participant is always challenged. A therapist will be in the room with participants to address any difficulties with the program and facilitate generation of strategies. PT will be delivered in both individual and group settings. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- psychotic disorder
- No previous cognitive remediation in past 6 months
Key exclusion criteria (4 listed)
- Brain injury
- Substance abuse
- Neurocognitive disorder
- Developmental Disability
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 - Executive TrainingCognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as memory, and problem solving ability. | Behavioural | Executive Training |
| Cognitive Remediation - Perceptual TrainingCognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as attention, and processing speed. | Behavioural | Perceptual Training |
Primary outcome
Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline
Time frame: Post-treatment (within 2 weeks following the end of treatment)
Rating scale completed by participants' case managers that rates their ability to perform different everyday tasks
7 secondary outcomes
Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline
Time frame: Post-treatment (within 2 weeks following the end of treatment)
Change in Neurophysiology - EEG from Baseline
Time frame: Post-treatment (within 2 weeks following the end of treatment)
Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline
Time frame: Post-treatment (within 2 weeks following the end of treatment)
Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline
Time frame: Follow-Up (3 months after the end of treatment)
Change in Neurocognition - MATRICS Cognitive Consensus Battery (MCCB) from Baseline
Time frame: Follow-Up (3 months after the end of treatment)
Change in Neurophysiology - EEG from Baseline
Time frame: Follow-Up (3 months after the end of treatment)
Functional Competence - Canadian Objective Assessment of Life Skills Brief (COALS-B) from Baseline
Time frame: Follow-Up (3 months after the end of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Derived from this study: PubMed 30845819Best MW, Milanovic M, Iftene F, Bowie CR. A Randomized Controlled Trial of Executive Functioning Training Compared With Perceptual Training for Schizophrenia Spectrum Disorders: Effects on Neurophysiology, Neurocognition, and Functioning. Am J Psychiatry. 2019 Apr 1;176(4):297-306. doi: 10.1176/appi.ajp.2018.18070849. Epub 2019 Mar 8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 - Executive Training and Cognitive Remediation - Perceptual Training in people with Psychotic Disorders, run by Queen's University at 1 site in Canada.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 14 Nov 2018. 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 Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Performance - Specific Levels of Functioning (SLOF) from Baseline (time frame: Post-treatment (within 2 weeks following the end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03024203, which also lists 1 linked publication.
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 14 Nov 2018.