SchizophreniaCOTESNCT01973270
Community-Based Cognitive Training in Early Schizophrenia
A study testing Neuroadaptive 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 determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset schizophrenia, schizoaffective, schizophreniform, and psychosis NOS who are being treated in community mental health settings. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia, Psychosis
- What is being tested?
- Neuroadaptive cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 21 Aug 2019
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of schizophrenia, schizoaffective disorder, psychosis Not Otherwise Specified (NOS), Unspecified Schizophrenia Spectrum Disorder, Schizophrenia Spectrum Disorder, Specified, or schizophreniform disorder with onset of first psychotic episode within the last 2 years.
- Good general physical health
- Between 18 and 35 years of age
- Is fluent and proficient in the English language
- Currently enrolled in PREP/BEAM services
- Achieved clinical stability (e.g., outpatient status for at least 1 month before study entry)
Who cannot join
- Any neurological disorder
- If clinically significant substance abuse occurs that is impeding the subject's ability to participate fully during recruitment, assessment, or training, the subject will be dropped from the study.
- Being treated with benztropine, diphenhydramine, or high doses of clozapine (>500 mg po qd) or olanzapine(to be determined on a case by case basis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Prevention and Recovery in Early Psychosis (PREP) Program
San Francisco, California, 94143
About this study
The purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset schizophrenia, schizoaffective, schizophreniform, and psychosis NOS who are being treated in community mental health settings. We will investigate the effects of web-based cognitive training exercises delivered on a portable laptop computer. The findings will provide us with valuable information on whether cognitive training can improve the cognition and functioning of young individuals early in the course of schizophrenia.
Read the detailed description
The purpose of this study is to perform a double-blind randomized controlled trial (RCT) in young patients with recent-onset (RO) schizophrenia to target improvement in cognitive functioning within real-world treatment settings. This multi-site study will be performed in 4 community mental health centers with specialized Early Intervention Services (EIS). We will compare the effects of web-based targeted cognitive training (TCT) vs. web-based general cognitive exercises (GCE), both delivered via portable laptop computers. We will investigate the behavioral and functional changes seen immediately after the intervention as well as at 6-month follow-up, compared to a no-training control group (NTC). This will be the first study to investigate cognitive enhancement for young RO schizophrenia patients in community mental health settings, using scalable interactive neurotechnology, and the first to compare two distinct cognitive training approaches. This study will generate high impact data on the potential for targeted pre-emotion of the downward spiral of in cognitive and functional disability that often characterizes psychotic illness. It will also generate valuable data on the relative effects of two distinct cognitive training approaches in schizophrenia, each derived from a very different theoretical rationale, providing much-needed information on the efficacy of a targeted "distributed neural system" training model derived from systems neuroscience vs. a "general cognitive stimulation" training model derived from neuropsychological rehabilitation approaches.
The aims of this project are based on the current state of early psychosis research, as well as our own experience successfully applying neuroscience-informed cognitive training in schizophrenia. It is now abundantly clear that cognitive/neural system dysfunction represents a significant risk factor for schizophrenia as well as a poor prognostic indicator. Functional outcome in RO schizophrenia is predicted by level of cognitive impairment and baseline cognitive reserve, and recent findings suggest that specialized EIS programs focusing only on symptom reduction and psychosocial support may not robustly improve long-term outcomes- indicating that critical treatment targets are not being addressed at present in early psychosis interventions. Cognitive dysfunction and underlying neural system inefficiency should therefore be one of the primary targets for pre-emptive intervention in early psychosis. In this study, we will determine whether we can achieve this goal using cognitive training delivered via a portable computer, in order to improve functional outcome in young individuals with RO schizophrenia.
- Conditions
- Schizophrenia, Psychosis
- Being tested
- Neuroadaptive 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.
Neuroadaptive cognitive trainingBehavioural
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 (20 hours), and a Social Module (10 hours). Features from the Cognitive Control module prototype have been expanded and incorporated into these new modules.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Cognitive Training - TCT | Experimental | Neuroadaptive cognitive training Receives: Behavioral: Neuroadaptive cognitive training |
| General Cognitive Exercises (GCE) | Experimental | Neuroadaptive cognitive training Receives: Behavioral: Neuroadaptive cognitive training |
| Treatment as Usual | No intervention | Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognition
Neurocognition will be assessed using the MATRICS Consensus Cognitive Battery [MCCB]. The MCCB assesses the following domains of neurocognitive functioning: 1) Speed of Processing, 2) Attention/Vigilance, 3) Working Memory, 4) Verbal Learning, 5) Visual Learning, 6) Reasoning and Problem Solving; and 7) Social Cognition. We will also assess Verbal Memory (HVLT delayed recall), Visual Memory (BVMT delayed recall), and administer an additional measure of Reasoning and Problem Solving [BACS Tower of London]. In addition to the MCCB measure of social cognition, we will assess the following constructs: affect recognition, emotional prosody [Penn Prosody Identification, and theory of mind [Faux Pas test.7 hours spread over 3 appointments in a 1-2 week period, 5 hours post-training and an additional 5 hours at a 6-month follow-up.
Measured: Baseline, Post-Training, 6 month Follow-up
Functioning
The Quality of Life Scale-Abbreviated will be our primary outcome measure of functional status. This measure assesses quality of life using subjective questions regarding life satisfaction and objective indicators of social and occupational functioning.
Measured: Baseline, Post-Training, 6 Month Follow-up
Auditory Processing Speed
Early target engagement is the degree to which an individual demonstrates initial performance improvement ("learning") upon exposure to training. Early target engagement will be measured by auditory processing speed during cognitive training exercises.
Measured: Baseline, 10 hours of training
Reward Sensitivity
The Temporal Experience of Pleasure Scale (TEPS) will be used to assess reward sensitivity.
Measured: Baseline
Secondary outcomes (3)
Functional Capacity
Secondary measures of functional capacity/status will include the following MATRICS-recommended measure: The UCSD Performance Based Skills Assessment [UPSA-Brief].
Measured: Baseline, Post-Training, 6 Month Follow-up
Social Functioning
Secondary measures of social functioning will include: The Social Functioning Scale.
Measured: Baseline, Post-Training, 6 Month Follow-up
Internalized Stigma
In order to measure internalized stigma, a component of recovery, we will use the Internalized Stigma of Mental Illness (ISMI) Scale.
Measured: Baseline, Post-Training, 6 Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startDec 2013
- Primary completion21 Aug 2019
- Study completion21 Aug 2019
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.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 174 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
- NCT01973270
- Sponsor's protocol ID
- R01MH102063-01
- Acronym
- COTES
- Status last verified
- Sep 2019
- First submitted
- 6 Aug 2013
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Cognitive Training in Early Schizophrenia
- ClinicalTrials.gov ID
- NCT01973270
- Acronym / sponsor ID
- COTES / R01MH102063-01
- Conditions
- Schizophrenia, Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- 21 Aug 2019 (actual)
- Study completion
- 21 Aug 2019 (actual)
- First posted
- 31 Oct 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 purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset schizophrenia, schizoaffective, schizophreniform, and psychosis NOS who are being treated in community mental health settings. We will investigate the effects of web-based cognitive training exercises delivered on a portable laptop computer. The findings will provide us with valuable information on whether cognitive training can improve the cognition and functioning of young individuals early in the course of schizophrenia.
Detailed description
The purpose of this study is to perform a double-blind randomized controlled trial (RCT) in young patients with recent-onset (RO) schizophrenia to target improvement in cognitive functioning within real-world treatment settings. This multi-site study will be performed in 4 community mental health centers with specialized Early Intervention Services (EIS). We will compare the effects of web-based targeted cognitive training (TCT) vs. web-based general cognitive exercises (GCE), both delivered via portable laptop computers. We will investigate the behavioral and functional changes seen immediately after the intervention as well as at 6-month follow-up, compared to a no-training control group (NTC). This will be the first study to investigate cognitive enhancement for young RO schizophrenia patients in community mental health settings, using scalable interactive neurotechnology, and the first to compare two distinct cognitive training approaches. This study will generate high impact data on the potential for targeted pre-emotion of the downward spiral of in cognitive and functional disability that often characterizes psychotic illness. It will also generate valuable data on the relative effects of two distinct cognitive training approaches in schizophrenia, each derived from a very different theoretical rationale, providing much-needed information on the efficacy of a targeted "distributed neural system" training model derived from systems neuroscience vs. a "general cognitive stimulation" training model derived from neuropsychological rehabilitation approaches.
The aims of this project are based on the current state of early psychosis research, as well as our own experience successfully applying neuroscience-informed cognitive training in schizophrenia. It is now abundantly clear that cognitive/neural system dysfunction represents a significant risk factor for schizophrenia as well as a poor prognostic indicator. Functional outcome in RO schizophrenia is predicted by level of cognitive impairment and baseline cognitive reserve, and recent findings suggest that specialized EIS programs focusing only on symptom reduction and psychosocial support may not robustly improve long-term outcomes- indicating that critical treatment targets are not being addressed at present in early psychosis interventions. Cognitive dysfunction and underlying neural system inefficiency should therefore be one of the primary targets for pre-emptive intervention in early psychosis. In this study, we will determine whether we can achieve this goal using cognitive training delivered via a portable computer, in order to improve functional outcome in young individuals with RO schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Targeted Cognitive Training - TCT | Experimental | Behavioral: Neuroadaptive cognitive trainingNeuroadaptive cognitive training |
| General Cognitive Exercises (GCE) | Experimental | Behavioral: Neuroadaptive cognitive trainingNeuroadaptive cognitive training |
| Treatment as Usual | No intervention | –Treatment as Usual |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of schizophrenia, schizoaffective disorder, psychosis Not Otherwise Specified (NOS), Unspecified Schizophrenia Spectrum Disorder, Schizophrenia Spectrum Disorder, Specified, or schizophreniform disorder with onset of first psychotic episode within the last 2 years.
- Good general physical health
- Between 18 and 35 years of age
- Is fluent and proficient in the English language
- Currently enrolled in PREP/BEAM services
Key exclusion criteria (3 listed)
- Any neurological disorder
- If clinically significant substance abuse occurs that is impeding the subject's ability to participate fully during recruitment, assessment, or training, the subject will be dropped from the study.
- Being treated with benztropine, diphenhydramine, or high doses of clozapine (>500 mg po qd) or olanzapine(to be determined on a case by case basis)
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 |
|---|---|---|
| Neuroadaptive cognitive trainingTCT 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 (20 hours), and a Social Module (10 hours). Features from the Cognitive Control module prototype have been expanded and incorporated into these new modules. | Behavioural | General Cognitive Exercises (GCE), Targeted Cognitive Training - TCT |
Primary outcome
Neurocognition
Time frame: Baseline, Post-Training, 6 month Follow-up
Neurocognition will be assessed using the MATRICS Consensus Cognitive Battery [MCCB]. The MCCB assesses the following domains of neurocognitive functioning: 1) Speed of Processing, 2) Attention/Vigilance, 3) Working Memory, 4) Verbal Learning, 5) Visual Learning, 6) Reasoning and Problem Solving; and 7) Social Cognition. We will also assess Verbal Memory (HVLT delayed recall), Visual Memory (BVMT delayed recall), and administer an additional measure of Reasoning and Problem Solving [BACS Tower of London]. In addition to the MCCB measure of social cognition, we will assess the following constructs: affect recognition, emotional prosody [Penn Prosody Identification, and theory of mind [Faux Pas test.7 hours spread over 3 appointments in a 1-2 week period, 5 hours post-training and an additional 5 hours at a 6-month follow-up.
Functioning
Time frame: Baseline, Post-Training, 6 Month Follow-up
The Quality of Life Scale-Abbreviated will be our primary outcome measure of functional status. This measure assesses quality of life using subjective questions regarding life satisfaction and objective indicators of social and occupational functioning.
Auditory Processing Speed
Time frame: Baseline, 10 hours of training
Early target engagement is the degree to which an individual demonstrates initial performance improvement ("learning") upon exposure to training. Early target engagement will be measured by auditory processing speed during cognitive training exercises.
Reward Sensitivity
Time frame: Baseline
The Temporal Experience of Pleasure Scale (TEPS) will be used to assess reward sensitivity.
3 secondary outcomes
Functional Capacity
Time frame: Baseline, Post-Training, 6 Month Follow-up
Social Functioning
Time frame: Baseline, Post-Training, 6 Month Follow-up
Internalized Stigma
Time frame: Baseline, Post-Training, 6 Month Follow-up
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 17 Sep 2019.
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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 Neuroadaptive 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 6 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 17 Sep 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?
Neurocognition (time frame: Baseline, Post-Training, 6 month Follow-up). The study lists 4 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 17 Sep 2019.