Psychotic DisordersNCT02584114
Brain Effects of Memory Training in Early Psychosis
A study testing Peak app for memory training and Non-memory training group in people with Psychotic Disorders, run by University of Calgary.
Trial summary
Background: People with psychosis show profound deficits in memory. A new cognitive remediation therapy using an app on a computer or mobile phone to improve memory has been effective in this population, but the neurobiological effects are unknown. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Peak app for memory training and Non-memory training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female and between the ages of 18 and 40
- Able to understand and sign an informed consent document in English.
- Meet diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychosis not otherwise specified.
Who cannot join
- Impaired intellectual functioning (full-scale IQ<70).
- Past or current history of a clinically significant central nervous system disorder that may contribute to psychotic symptoms or confound their assessment.
- Current severe substance use disorder.
About this study
Background: People with psychosis show profound deficits in memory. A new cognitive remediation therapy using an app on a computer or mobile phone to improve memory has been effective in this population, but the neurobiological effects are unknown.
Objectives: 1) To use functional magnetic resonance imaging (fMRI) to examine brain changes during a working memory task before and after a 12 hour memory training intervention on a computer or mobile phone, 2) To use diffusion tensor imaging (DTI) to examine white matter connecting prefrontal and parietal lobe before and after training.
Methods: 46 people with psychosis will be randomized to a computerized training of either memory training or a control condition of non-memory games (language/card games) and will self-administer 4 hours of training over 4 days per week, for 3 weeks (12 hours total). Memory training will be done with the Peak app http://www.peak.net. Imaging data will be gathered with a 3 Tesla scanner pre and post training.
- Conditions
- Psychotic Disorders
- Being tested
- Peak app for memory training, Non-memory training group
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peak app for memory trainingBehavioural
Non-memory training groupBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Memory training group | Experimental | The intervention is self-administration of 4 hours of memory training over 4 days per week, for 3 weeks (12 hours total). Memory training will be done with the Peak app for memory training http://www.peak.net. Receives: Behavioral: Peak app for memory training |
| Non-memory training group | Active comparator | The intervention is self-administration of 4 hours of training of games that do not involve memory such as language and card games over 4 days per week, for 3 weeks (12 hours total). Receives: Behavioral: Non-memory training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional Magnetic Resonance Imaging blood oxygen-dependent signal during working memory task performance before and after a 12 hour memory training intervention in people with early psychosis
Measured: 5 weeks
Change in diffusion tensor imaging measured change in fractional anisotropy during working memory task performance before and after a 12 hour memory training intervention in people with early psychosis
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startSep 2016
- 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.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Lisa Buchy, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584114
- Sponsor's protocol ID
- REB15_2463
- Status last verified
- Aug 2021
- First submitted
- 15 Oct 2015
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Effects of Memory Training in Early Psychosis
- ClinicalTrials.gov ID
- NCT02584114
- Acronym / sponsor ID
- REB15_2463
- Conditions
- Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- Sep 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 22 Oct 2015 (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.
Background: People with psychosis show profound deficits in memory. A new cognitive remediation therapy using an app on a computer or mobile phone to improve memory has been effective in this population, but the neurobiological effects are unknown.
Objectives: 1) To use functional magnetic resonance imaging (fMRI) to examine brain changes during a working memory task before and after a 12 hour memory training intervention on a computer or mobile phone, 2) To use diffusion tensor imaging (DTI) to examine white matter connecting prefrontal and parietal lobe before and after training.
Methods: 46 people with psychosis will be randomized to a computerized training of either memory training or a control condition of non-memory games (language/card games) and will self-administer 4 hours of training over 4 days per week, for 3 weeks (12 hours total). Memory training will be done with the Peak app http://www.peak.net. Imaging data will be gathered with a 3 Tesla scanner pre and post training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memory training group | Experimental | Behavioral: Peak app for memory trainingThe intervention is self-administration of 4 hours of memory training over 4 days per week, for 3 weeks (12 hours total). Memory training will be done with the Peak app for memory training http://www.peak.net. |
| Non-memory training group | Active comparator | Behavioral: Non-memory training groupThe intervention is self-administration of 4 hours of training of games that do not involve memory such as language and card games over 4 days per week, for 3 weeks (12 hours total). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female and between the ages of 18 and 40
- Able to understand and sign an informed consent document in English.
- Meet diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychosis not otherwise specified.
Key exclusion criteria (3 listed)
- Impaired intellectual functioning (full-scale IQ<70).
- Past or current history of a clinically significant central nervous system disorder that may contribute to psychotic symptoms or confound their assessment.
- Current severe substance use disorder.
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 |
|---|---|---|
| Peak app for memory training | Behavioural | Memory training group |
| Non-memory training group | Behavioural | Non-memory training group |
Primary outcome
Change in functional Magnetic Resonance Imaging blood oxygen-dependent signal during working memory task performance before and after a 12 hour memory training intervention in people with early psychosis
Time frame: 5 weeks
Change in diffusion tensor imaging measured change in fractional anisotropy during working memory task performance before and after a 12 hour memory training intervention in people with early psychosis
Time frame: 5 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
Related trials for Psychotic Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
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.
Questions about this trial
What is this clinical trial studying?
A study testing Peak app for memory training and Non-memory training group in people with Psychotic Disorders, run by University of Calgary.
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 3 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: stopped early, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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 Magnetic Resonance Imaging blood oxygen-dependent signal during working memory task performance before and after a 12 hour memory training intervention in people with early psychosis (time frame: 5 weeks). The study lists 2 primary outcomes in all. 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 13 Aug 2021.