Psychotic DisordersSTExFxNCT02168166
Short-term Working Memory and Executive Training
A study testing Executive Function Training in people with Psychotic Disorders, run by Queen's University at 1 site in Canada.
Trial summary
Cognitive remediation (CR) therapies refer to a number of recent developments to use behavioural strategies to improve neurocognitive abilities and improve everyday functioning in mental disorders such as schizophrenia, bipolar disorder, and depression. 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?
- Executive Function Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Jun 2017
- 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
- diagnosis of a chronic mental disorder (defined herein as bipolar disorder, major depressive disorder, or a schizophrenia-spectrum disorder)
- between the ages of 18 and 65
- speak and read fluent English
- able to use a computer
Who cannot join
- active substance abuse or dependence diagnosis
- sensory or motor issues that would preclude completion of study procedures
- enrollment in a cognitive remediation program or use of cognitive training programs (e.g. lumosity.com) within the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-Term Executive Functioning Training
Cognitive remediation (CR) therapies refer to a number of recent developments to use behavioural strategies to improve neurocognitive abilities and improve everyday functioning in mental disorders such as schizophrenia, bipolar disorder, and depression. In this study, we aim to examine whether we can observe CR effects on measures of neuroplasticity, cognition, and functioning when using a rigorous control comparison group. We hypothesize that the active group will exhibit improvements in executive functioning composite scores, improved EEG theta-gamma frequency modulation, and increased EEG alpha power compared to the placebo group.
- Conditions
- Psychotic Disorders
- Being tested
- Executive Function Training, Placebo
- Keywords
- Neurological Disorders, Neuroscience, Neuropsychology, EEG, Cognitive remediation, Cognitive Response
- Medical subject headings
- Psychotic Disorders, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive Function TrainingBehavioural
PlaceboBehavioural
Placebo version of executive function training
| Study group | Role | What they receive |
|---|---|---|
| Executive Function Training | Active comparator | Two weeks of training of cognitive domain of executive functioning
Using online program (Scientific Brain Training Pro)
Four exercises Receives: Behavioral: Executive Function Training |
| Placebo Training | Placebo comparator | Two weeks of training with exercises not affecting working memory, information processing speed, or cognitive load
Exercises maintain other traditional progressive aspects to preserve appearance of dynamic titration of difficulty levels
Using online program (Scientific Brain Training Pro)
Four exercises Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline executive functioning composite score at post-treatment assessment
Composite score based on four tests of cognition
Measured: Pre-training assessment (Week 1) and post-training assessment (Week 4)
Secondary outcomes (2)
Change from baseline EEG theta-gamma frequency modulation at post-treatment assessment
Predicted to improve in active CR (cognitive remediation) condition compared to placebo CR
Measured: Pre-training assessment (Week 1) and post-training assessment (Week 4)
Change from baseline EEG alpha power at post-treatment assessment
Predicted to increase in active CR (cognitive remediation) condition compared to placebo CR
Measured: Pre-training assessment (Week 1) and post-training assessment (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christopher Bowie, Queen's University
- Investigators
- Christopher Bowie, PhD, CPsych, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168166
- Sponsor's protocol ID
- GPSYC-651-14
- Acronym
- STExFx
- Status last verified
- Apr 2018
- First submitted
- 16 Jun 2014
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Executive Functioning Training
- ClinicalTrials.gov ID
- NCT02168166
- Acronym / sponsor ID
- STExFx / GPSYC-651-14
- Conditions
- Psychotic Disorders
- Keywords
- Neurological Disorders, Neuroscience, Neuropsychology, EEG, Cognitive remediation, Cognitive Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Jun 2014 (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) therapies refer to a number of recent developments to use behavioural strategies to improve neurocognitive abilities and improve everyday functioning in mental disorders such as schizophrenia, bipolar disorder, and depression. In this study, we aim to examine whether we can observe CR effects on measures of neuroplasticity, cognition, and functioning when using a rigorous control comparison group. We hypothesize that the active group will exhibit improvements in executive functioning composite scores, improved EEG theta-gamma frequency modulation, and increased EEG alpha power compared to the placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Executive Function Training | Active comparator | Behavioral: Executive Function TrainingTwo weeks of training of cognitive domain of executive functioning Using online program (Scientific Brain Training Pro) Four exercises |
| Placebo Training | Placebo comparator | Behavioral: PlaceboTwo weeks of training with exercises not affecting working memory, information processing speed, or cognitive load Exercises maintain other traditional progressive aspects to preserve appearance of dynamic titration of difficulty levels Using online program (Scientific Brain Training Pro) Four exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of a chronic mental disorder (defined herein as bipolar disorder, major depressive disorder, or a schizophrenia-spectrum disorder)
- between the ages of 18 and 65
- speak and read fluent English
- able to use a computer
Key exclusion criteria (3 listed)
- active substance abuse or dependence diagnosis
- sensory or motor issues that would preclude completion of study procedures
- enrollment in a cognitive remediation program or use of cognitive training programs (e.g. lumosity.com) within the past 6 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 |
|---|---|---|
| Executive Function Training | Behavioural | Executive Function Training |
| PlaceboPlacebo version of executive function training | Behavioural | Placebo Training |
Primary outcome
Change from baseline executive functioning composite score at post-treatment assessment
Time frame: Pre-training assessment (Week 1) and post-training assessment (Week 4)
Composite score based on four tests of cognition
2 secondary outcomes
Change from baseline EEG theta-gamma frequency modulation at post-treatment assessment
Time frame: Pre-training assessment (Week 1) and post-training assessment (Week 4)
Change from baseline EEG alpha power at post-treatment assessment
Time frame: Pre-training assessment (Week 1) and post-training assessment (Week 4)
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 4 Apr 2018.
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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.
Christopher Bowie, PhD, CPsych principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Executive Function 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 4 inclusion and 3 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 4 Apr 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. 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?
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 from baseline executive functioning composite score at post-treatment assessment (time frame: Pre-training assessment (Week 1) and post-training assessment (Week 4)). 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 4 Apr 2018.