SchizophreniaCASTNCT02105779
Optimizing Cognitive Remediation Outcomes in Schizophrenia
A study testing Targeted Cognitive Training and Social Cognitive Training in people with Schizophrenia and Psychosis, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to drive an optimal response to neuroplasticity-based cognitive remediation in schizophrenia in order to maximize treatment response. The investigators will investigate factors that have generally been ignored in prior computer-based cognitive remediation programs-those related to social… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychosis
- What is being tested?
- Targeted Cognitive Training and Social Cognitive Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to 26 Jul 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of schizophrenia or schizoaffective disorder
- Between 18-65 years of age
- Clinically stable
- Fluent in English
Who cannot join
- Recent hospitalization, in the past 3 months
- History of traumatic brain injury
- Neurological disorders
- Inability to participate in the study soberly
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Veterans Medical Center
San Francisco, California, 94121
About this study
The purpose of this study is to drive an optimal response to neuroplasticity-based cognitive remediation in schizophrenia in order to maximize treatment response. The investigators will investigate factors that have generally been ignored in prior computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. Current research indicates that, unless the investigators fully understand and harness these factors, the investigators will not achieve meaningful treatment gains for individuals with schizophrenia.
Read the detailed description
The purpose of this study is to explicitly and aggressively drive an optimal response to neuroplasticity- based cognitive remediation in schizophrenia in order to maximize treatment response. We will investigate factors that have generally been ignored in computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. Current research indicates that, unless we fully understand and harness these factors, we will not achieve meaningful treatment gains for individuals with schizophrenia.
Our specific aims are:
- To perform an RCT in which 100 schizophrenia subjects are assigned to either 60 hours of neuroplasticity- based computerized targeted cognitive training (TCT) that focuses exclusively on "cold cognition" (a program which trains early sensory processing, attention, working memory and cognitive control in auditory and visual domains), or to 60 hours of training that combines the TCT program with 20 minutes per day of adaptive computerized social cognition training (SCT) exercises.
- To compare the outcomes of these two groups of subjects on measures of neurocognition, social cognition, motivation, and functional outcome.
- To assess subjects six months after the intervention to determine the durability of training effects.
- To identify changes in brain activation patterns in key neural regions as a result of TCT alone vs. TCT+SCT: during reward anticipation, and during emotion recognition.
The timeliness of this approach is supported by recent evidence demonstrating only weak associations between traditional cognitive remediation approaches and functional outcome in schizophrenia, but a strong, direct relationship between social cognition and functional outcome. Thus we must now examine the clinical, functional, and neural effects of a well-designed state-of-the-art cognitive training program that combines neurocognition with social cognition training.
- Conditions
- Schizophrenia, Psychosis
- Being tested
- Targeted Cognitive Training, Social Cognitive Training
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Cognitive TrainingOther
At present, the TCT exercises consist of three modules: an Auditory Processing Module (40-50 hours of training); a Visual Processing Module (30 hours); a Cognitive Control Module prototype (20 hours). [Based on the results of our current RCT, Posit Science has revised aspects of the training modules in order to further optimize its effectiveness for treatment of schizophrenia. In this study, we will use updated versions of the training software: an Auditory Module (30 hours), and a Visual Module (30 hours). Features from the Cognitive Control module prototype have been expanded and incorporated into these new modules.
Social Cognitive TrainingOther
We developed a systematic approach to basic training in facial emotion identification and discrimination and simple social perception and theory of mind tasks using components drawn from three commercially available software packages: the MicroExpressions Training Tool and The Subtle Expressions Training Tool (METT and SETT), plus the MindReading program. Training begins with simple emotion identification tasks, and slowly progressed to more difficult tasks that required subjects to discriminate between two subtle emotion expressions, and to correctly interpret the emotional significance of brief social scenes. A total of 10 hours of training occurred over 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Cognitive Training | Experimental | 40 hours of BFP auditory training Receives: Other: Targeted Cognitive Training |
| Social Cognitive Training | Experimental | 40 hours of auditory training and 10 hours social exercises Receives: Other: Social Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Social Cognition at 6 months
Social functioning scale
Measured: Baseline (Intake)/6 months follow-up after trianing completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startDec 2009
- Primary completionMay 2016
- Study completion26 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophia Vinogradov, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105779
- Sponsor's protocol ID
- R01MH082818
- Acronym
- CAST
- Status last verified
- Apr 2019
- First submitted
- 11 Mar 2014
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Fisher M, Nahum M, Howard E, Rowlands A, Brandrett B, Kermott A, Woolley J, Vinogradov S. Supplementing intensive targeted computerized cognitive training with social cognitive exercises for people with schizophrenia: An interim report. Psychiatr Rehabil J. 2017 Mar;40(1):21-32. doi: 10.1037/prj0000244.
PubMed 28368179Biagianti B, Fisher M, Neilands TB, Loewy R, Vinogradov S. Engagement with the auditory processing system during targeted auditory cognitive training mediates changes in cognitive outcomes in individuals with schizophrenia. Neuropsychology. 2016 Nov;30(8):998-1008. doi: 10.1037/neu0000311. Epub 2016 Sep 12.
PubMed 27617637
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cognitive Remediation Outcomes in Schizophrenia
- ClinicalTrials.gov ID
- NCT02105779
- Acronym / sponsor ID
- CAST / R01MH082818
- Conditions
- Schizophrenia, Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2016 (actual)
- Study completion
- 26 Jul 2016 (actual)
- First posted
- 7 Apr 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.
The purpose of this study is to drive an optimal response to neuroplasticity-based cognitive remediation in schizophrenia in order to maximize treatment response. The investigators will investigate factors that have generally been ignored in prior computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. Current research indicates that, unless the investigators fully understand and harness these factors, the investigators will not achieve meaningful treatment gains for individuals with schizophrenia.
Detailed description
The purpose of this study is to explicitly and aggressively drive an optimal response to neuroplasticity- based cognitive remediation in schizophrenia in order to maximize treatment response. We will investigate factors that have generally been ignored in computer-based cognitive remediation programs-those related to social cognition-- and will delineate their relationship to motivation, functional outcome, and the neural substrates of reward anticipation and emotion processing. Current research indicates that, unless we fully understand and harness these factors, we will not achieve meaningful treatment gains for individuals with schizophrenia.
Our specific aims are:
- To perform an RCT in which 100 schizophrenia subjects are assigned to either 60 hours of neuroplasticity- based computerized targeted cognitive training (TCT) that focuses exclusively on "cold cognition" (a program which trains early sensory processing, attention, working memory and cognitive control in auditory and visual domains), or to 60 hours of training that combines the TCT program with 20 minutes per day of adaptive computerized social cognition training (SCT) exercises.
- To compare the outcomes of these two groups of subjects on measures of neurocognition, social cognition, motivation, and functional outcome.
- To assess subjects six months after the intervention to determine the durability of training effects.
- To identify changes in brain activation patterns in key neural regions as a result of TCT alone vs. TCT+SCT: during reward anticipation, and during emotion recognition.
The timeliness of this approach is supported by recent evidence demonstrating only weak associations between traditional cognitive remediation approaches and functional outcome in schizophrenia, but a strong, direct relationship between social cognition and functional outcome. Thus we must now examine the clinical, functional, and neural effects of a well-designed state-of-the-art cognitive training program that combines neurocognition with social cognition training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Cognitive Training | Experimental | Other: Targeted Cognitive Training40 hours of BFP auditory training |
| Social Cognitive Training | Experimental | Other: Social Cognitive Training40 hours of auditory training and 10 hours social exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of schizophrenia or schizoaffective disorder
- Between 18-65 years of age
- Clinically stable
- Fluent in English
Key exclusion criteria (4 listed)
- Recent hospitalization, in the past 3 months
- History of traumatic brain injury
- Neurological disorders
- Inability to participate in the study soberly
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 |
|---|---|---|
| Targeted Cognitive TrainingAt present, the TCT exercises consist of three modules: an Auditory Processing Module (40-50 hours of training); a Visual Processing Module (30 hours); a Cognitive Control Module prototype (20 hours). [Based on the results of our current RCT, Posit Science has revised aspects of the training modules in order to further optimize its effectiveness for treatment of schizophrenia. In this study, we will use updated versions of the training software: an Auditory Module (30 hours), and a Visual Module (30 hours). Features from the Cognitive Control module prototype have been expanded and incorporated into these new modules. | Other | Targeted Cognitive Training |
| Social Cognitive TrainingWe developed a systematic approach to basic training in facial emotion identification and discrimination and simple social perception and theory of mind tasks using components drawn from three commercially available software packages: the MicroExpressions Training Tool and The Subtle Expressions Training Tool (METT and SETT), plus the MindReading program. Training begins with simple emotion identification tasks, and slowly progressed to more difficult tasks that required subjects to discriminate between two subtle emotion expressions, and to correctly interpret the emotional significance of brief social scenes. A total of 10 hours of training occurred over 8 weeks. | Other | Social Cognitive Training |
Primary outcome
Change from Baseline Social Cognition at 6 months
Time frame: Baseline (Intake)/6 months follow-up after trianing completion
Social functioning scale
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 5 Apr 2019.
- Derived from this study: PubMed 28368179Fisher M, Nahum M, Howard E, Rowlands A, Brandrett B, Kermott A, Woolley J, Vinogradov S. Supplementing intensive targeted computerized cognitive training with social cognitive exercises for people with schizophrenia: An interim report. Psychiatr Rehabil J. 2017 Mar;40(1):21-32. doi: 10.1037/prj0000244.
- Derived from this study: PubMed 27617637Biagianti B, Fisher M, Neilands TB, Loewy R, Vinogradov S. Engagement with the auditory processing system during targeted auditory cognitive training mediates changes in cognitive outcomes in individuals with schizophrenia. Neuropsychology. 2016 Nov;30(8):998-1008. doi: 10.1037/neu0000311. Epub 2016 Sep 12.
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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.
Sophia Vinogradov, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Cognitive Training and Social Cognitive Training in people with Schizophrenia and Psychosis, run by University of California, San Francisco at 1 site in United States.
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 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 5 Apr 2019. 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 United States. 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 from Baseline Social Cognition at 6 months (time frame: Baseline (Intake)/6 months follow-up after trianing completion). 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 NCT02105779, which also lists 2 linked publications.
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 Apr 2019.