Clinical High Risk for PsychosisNCT02404194
Targeted Cognitive Training in Clinical High Risk (CHR) for Psychosis
A study testing Targeted Cognitive Training and Computer Games in people with Clinical High Risk for Psychosis, run by Rush University Medical Center at 1 site in United States.
Trial summary
This project is a randomized-controlled trial to test the efficacy of computer-based targeted cognitive training (TCT) versus a placebo intervention of commercial computer games in adolescent/young adults at clinical high risk (CHR) for psychosis. Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Clinical High Risk for Psychosis
- What is being tested?
- Targeted Cognitive Training and Computer Games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 15 Feb 2021
- 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 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- English speaking
- One or more psychosis-risk syndromes as defined by the Structured Interview for Psychosis-Risk Syndromes (SIPS)
Who cannot join
- Intelligence Quotient (IQ) < 70
- Major medical illness or neurological disorder
- Lifetime history of Axis I psychotic disorder and/or clear evidence that psychosis-risk syndrome is due to non-schizophrenia-spectrum Axis I or Axis II disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Optimizing Cognitive Training to Improve Functional Outcome in Clinical High Risk (CHR)
This project is a randomized-controlled trial to test the efficacy of computer-based targeted cognitive training (TCT) versus a placebo intervention of commercial computer games in adolescent/young adults at clinical high risk (CHR) for psychosis. TCT is designed to optimize learning-induced neuroplasticity in vulnerable neurocognitive systems. A main aim is to test the hypothesis that this neuroscience-guided TCT intervention will improve neural function, and that these neural improvements will improve cognition and functional outcome. CHR participants will be randomly assigned to 40 hours of TCT or placebo computer games completed within 10 weeks. TCT consists of 20 hours of training in cognition, including processing speed, memory, attention, and cognitive control followed by 20 hours of training in social cognition including affect recognition and theory of mind. Neuroimaging, cognition, social cognition, clinical symptoms, and functional status will be assessed at baseline, after 20 hours/5 weeks of cognitive training (mid-intervention), and after 20 hours/5 weeks of social-cognitive training (post-intervention). Cognition, social cognition, symptoms, and functioning will also be assessed at a 9 month follow-up (i.e. 9 months after intervention completion). We predict that TCT will lead to improvements in neurocognitive function and functional status. The results of this study will provide important information about a benign, non-pharmacological intervention for improving cognition and functional outcome in CHR individuals.
- Conditions
- Clinical High Risk for Psychosis
- Being tested
- Targeted Cognitive Training, Computer Games
- Keywords
- schizophrenia, psychosis, at risk, prodrome, attenuated psychosis syndrome
- 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 TrainingBehavioural
Also called Posit Science
Targeted Cognitive Training is performed on the computer through Posit Science. Games are modern and engaging modifications of classic neuropsychological tests, such as set-shifting games modeled on the Wisconsin Card Sort Test, and cognitive control games modeled on Stroop-like interference tasks. Games will target two sets of skills: Targeted cognitive skills include: processing speed, memory, attention, flexibility/cognitive-control, and problem-solving. After 20 hours of training on these skills, participants will complete 20 hours of training on core social cognitive skills, including facial affect recognition, gaze direction perception, and face identity recognition, and theory of mind.
Computer GamesBehavioural
The comparison intervention consists of 40 hours of commercially available and cognitively non-specific computer games. These computer games - such as checkers, solitaire, crossword puzzles - are entertaining and engaging but do not target specific neurocognitive skills.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Cognitive Training | Experimental | 40 hours of computerized cognitive training Receives: Behavioral: Targeted Cognitive Training |
| Computer Games | Placebo comparator | 40 hours of computer games Receives: Behavioral: Computer Games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
Behavioral assessment of cognition
Measured: Change in cognition from baseline (pre-intervention) to 10 weeks (post-intervention)
Secondary outcomes (1)
Global Function: Social and Role Scales
Behavioral assessment of daily functioning
Measured: Change in functioning from baseline (pre-intervention) to 10 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion23 Nov 2020
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical High Risk for PsychosisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Beth Israel Deaconess Medical Center, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Christine Hooker, Rush University Medical Center
- Investigators
- Christine I Hooker, PhD, Principal investigator, Rush University Medical Center, Dept of Psychiatry & Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404194
- Sponsor's protocol ID
- MH105246
- Other IDs
- R01MH105246
- Status last verified
- Dec 2022
- First submitted
- 16 Mar 2015
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cognitive Training to Improve Functional Outcome in Clinical High Risk (CHR)
- ClinicalTrials.gov ID
- NCT02404194
- Acronym / sponsor ID
- MH105246
- Conditions
- Clinical High Risk for Psychosis
- Keywords
- schizophrenia, psychosis, at risk, prodrome, attenuated psychosis syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM), Beth Israel Deaconess Medical Center, National Institute of Mental Health (NIMH)
- Study start
- Mar 2015
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 31 Mar 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.
This project is a randomized-controlled trial to test the efficacy of computer-based targeted cognitive training (TCT) versus a placebo intervention of commercial computer games in adolescent/young adults at clinical high risk (CHR) for psychosis. TCT is designed to optimize learning-induced neuroplasticity in vulnerable neurocognitive systems. A main aim is to test the hypothesis that this neuroscience-guided TCT intervention will improve neural function, and that these neural improvements will improve cognition and functional outcome. CHR participants will be randomly assigned to 40 hours of TCT or placebo computer games completed within 10 weeks. TCT consists of 20 hours of training in cognition, including processing speed, memory, attention, and cognitive control followed by 20 hours of training in social cognition including affect recognition and theory of mind. Neuroimaging, cognition, social cognition, clinical symptoms, and functional status will be assessed at baseline, after 20 hours/5 weeks of cognitive training (mid-intervention), and after 20 hours/5 weeks of social-cognitive training (post-intervention). Cognition, social cognition, symptoms, and functioning will also be assessed at a 9 month follow-up (i.e. 9 months after intervention completion). We predict that TCT will lead to improvements in neurocognitive function and functional status. The results of this study will provide important information about a benign, non-pharmacological intervention for improving cognition and functional outcome in CHR individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Cognitive Training | Experimental | Behavioral: Targeted Cognitive Training40 hours of computerized cognitive training |
| Computer Games | Placebo comparator | Behavioral: Computer Games40 hours of computer games |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- English speaking
- One or more psychosis-risk syndromes as defined by the Structured Interview for Psychosis-Risk Syndromes (SIPS)
Key exclusion criteria (3 listed)
- Intelligence Quotient (IQ) < 70
- Major medical illness or neurological disorder
- Lifetime history of Axis I psychotic disorder and/or clear evidence that psychosis-risk syndrome is due to non-schizophrenia-spectrum Axis I or Axis II 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 |
|---|---|---|
| Targeted Cognitive TrainingAlso: Posit ScienceTargeted Cognitive Training is performed on the computer through Posit Science. Games are modern and engaging modifications of classic neuropsychological tests, such as set-shifting games modeled on the Wisconsin Card Sort Test, and cognitive control games modeled on Stroop-like interference tasks. Games will target two sets of skills: Targeted cognitive skills include: processing speed, memory, attention, flexibility/cognitive-control, and problem-solving. After 20 hours of training on these skills, participants will complete 20 hours of training on core social cognitive skills, including facial affect recognition, gaze direction perception, and face identity recognition, and theory of mind. | Behavioural | Targeted Cognitive Training |
| Computer GamesThe comparison intervention consists of 40 hours of commercially available and cognitively non-specific computer games. These computer games - such as checkers, solitaire, crossword puzzles - are entertaining and engaging but do not target specific neurocognitive skills. | Behavioural | Computer Games |
Primary outcome
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
Time frame: Change in cognition from baseline (pre-intervention) to 10 weeks (post-intervention)
Behavioral assessment of cognition
1 secondary outcome
Global Function: Social and Role Scales
Time frame: Change in functioning from baseline (pre-intervention) to 10 weeks (post-intervention)
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 2 Dec 2022.
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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.
Christine I Hooker, PhD principal investigator
Rush University Medical Center, Dept of Psychiatry & Behavioral Sciences
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 Computer Games in people with Clinical High Risk for Psychosis, run by Rush University Medical Center 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 2 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 2 Dec 2022. 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. 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?
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (time frame: Change in cognition from baseline (pre-intervention) to 10 weeks (post-intervention)). 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 2 Dec 2022.