SchizophreniaNCT04123223
Comparing Cognitive Remediation Approaches for Schizophrenia
A study testing Cognitive Remediation and Computer Games in people with Schizophrenia and Schizoaffective Disorder, run by Wesleyan University at 2 sites in United States.
Trial summary
This research compares the relative efficacy of two empirically-supported, standardized programs of cognitive remediation for treatment of cognitive deficits and community function in schizophrenia to help inform best practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Cognitive Remediation 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
- 135 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2019to Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting DSM-5 criteria for schizophrenia or schizoaffective disorder, presenting for intensive outpatient clinical care.
- Stabilized on atypical antipsychotic medication for a minimum of 2 months prior to entry into the protocol.
- A minimum of 2 months since discharge from last hospitalization.
- -
Who cannot join
- Uncorrected auditory or visual impairment.
- Mental retardation (Full Scale IQ<70, as estimated by single word-reading from the WRAT and/or evidence of a history of services).
- Traumatic brain injury with loss of consciousness for more than 10 minutes.
- Presence or history of any neurologic illness.
- Lack of proficiency in English
- Criteria met for concurrent substance dependence,
- Scoring within 1SD of healthy control performance (from published norms) on measures of visual vigilance, verbal learning, and working memory.
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute of Living
Hartford, Connecticut, 06102
River Valley Services
Middletown, Connecticut, 06457
About this study
This research compares the relative efficacy of two empirically-supported, standardized programs of cognitive remediation for treatment of cognitive deficits and community function in schizophrenia to help inform best practices. The proposed study advances public health by developing and evaluating new behavioral techniques for improving psychosocial outcome in individuals diagnosed with schizophrenia.
Read the detailed description
Evidence over the past 30 years has revealed that 70-80% of individuals with schizophrenia exhibit marked neurocognitive deficits on measures of attention, learning and memory, problem-solving, language and sensory-motor skill. Particular significance has been attached to these deficits as their severity has been linked to impaired community function, social problem-solving and progress in psychosocial rehabilitation programs. Cognitive remediation (CR) is a type of behavioral intervention that addresses cognitive deficits in schizophrenia by restoring lost cognitive skills or providing strategies for bypassing deficits through task practice. Meta-analyses have revealed that cognitive remediation is a validated approach to improving cognitive function in schizophrenia, however a lack of precision regarding the active elements of the intervention have prevented its recommendation as a standard treatment for the illness. The present three-year proposal seeks to identify cognitive training mechanisms that are most effective at improving cognitive function in schizophrenia by comparing two different systematic programs of CR with different foci: drill-and-practice exercises vs. compensatory strategies. Both programs have strong preliminary empirical support. One-hundred and thirty-five clients diagnosed with schizophrenia or schizoaffective disorder will be randomly assigned to one of three groups: a neuroplasticity-based, drill-and-practice program of computer-assisted cognitive training exercises designed to restore lost cognitive capacity; a manualized strategy training method for bypassing deficits in cognition, or a computer games control condition. Study measures, organized according to an experimental therapeutics approach, with targets distinguished from outcomes, will assess generalization of any observed training effects.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Cognitive Remediation, Computer Games
- 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.
Cognitive RemediationBehavioural
Cognitive remediation (CR) is a behavioral treatment designed to address neurocognitive deficits through task practice and/or strategy acquisition.
Computer GamesBehavioural
Sham placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| Restorative CR Intervention | Experimental | The restorative remediation intervention will consist of a target of 50 hours (5 hours per week, 1 hour per day, over 3 months) of a sequence of computerized cognitive exercises designed to improve cognitive function through repeated drill-and-practice of exercises largely focused on attention, working memory and verbal episodic memory. Cognitive deficits will be directly targeted by these exercises. Exercises will be started at individually determined levels of difficulty at which each client will be successful, e.g., 80% accuracy. Task difficulty will be increased as performance improves. Receives: Behavioral: Cognitive Remediation |
| Strategy CR Intervention | Experimental | Participants in this intervention will be treated for 24 hours (2 hours per week, one day per week over 3 months) with Compensatory Cognitive Training (CCT). The therapy targets four cognitive domains: (a) prospective memory, (b) attention and vigilance, (c) learning and memory, and (d) executive function. The program is a group-based intervention that teaches strategies via interactive, game-like activities to maintain interest and enhance motivation and engagement. Receives: Behavioral: Cognitive Remediation |
| Computer Games | Placebo comparator | Three months of 1-hour, 5-times per week, client-selected computer games. Receives: Behavioral: Computer Games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matrics Consensus Cognitive Battery score (MCCB composite score)
The MCCB includes state-of-the-art cognitive probes selected by 74 experts using the RAND panel method. The battery has strong reliability in schizophrenia and includes multiple forms for many subtests to help control for practice effects. Summary T-scores range from 20 to 80 with higher scores indicating better cognitive performance.
Measured: Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
UCSD Performance-Based Skills Assessment
This standardized performance-based instrument of everyday function, with evidence of reliability and validity in schizophrenia samples, provides information regarding patients' ability to manage information/planning, finance, communications, mobility and household management in role-play situations.Scores range from 0-20 with higher scores indicating better functioning.
Measured: Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
Quality of Life Scale
A 21-item scale commonly used as a measure of psychosocial functioning in schizophrenia. The Quality-of-Life Scale balances subjective questions regarding life satisfaction and objective indicators of social and occupational role functioning.Scores range from 0-42 with higher scores indicating better functioning.
Measured: Measures change from study entry, after 3-months of treatment and at a 3-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 posted10 Oct 2019
- Study start1 Nov 2019
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
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.
- 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
- Model description
- Cognitive remediation (CR) is a type of behavioral intervention that addresses cognitive deficits in schizophrenia by restoring lost cognitive skills or providing strategies for bypassing deficits through task practice. The present project seeks to identify cognitive training mechanisms that are most effective at improving cognitive function in schizophrenia by comparing two different systematic programs of CR with different foci: drill-and-practice exercises vs. compensatory strategies.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wesleyan University
- Sponsor type
- University, hospital or other
- Collaborators
- Hartford Hospital, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Matthew M. Kurtz, Wesleyan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123223
- Sponsor's protocol ID
- 1R15MH117676-01A1
- Other IDs
- 1R15MH117676-01A1
- Status last verified
- Aug 2020
- First submitted
- 3 Oct 2019
- Last updated
- 14 Aug 2020
- 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 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Cognitive Remediation Approaches for Schizophrenia
- ClinicalTrials.gov ID
- NCT04123223
- Acronym / sponsor ID
- 1R15MH117676-01A1
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Wesleyan UniversityUniversity, hospital or other
- Collaborators
- Hartford Hospital, National Institute of Mental Health (NIMH)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 10 Oct 2019 (actual)
- 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 research compares the relative efficacy of two empirically-supported, standardized programs of cognitive remediation for treatment of cognitive deficits and community function in schizophrenia to help inform best practices. The proposed study advances public health by developing and evaluating new behavioral techniques for improving psychosocial outcome in individuals diagnosed with schizophrenia.
Detailed description
Evidence over the past 30 years has revealed that 70-80% of individuals with schizophrenia exhibit marked neurocognitive deficits on measures of attention, learning and memory, problem-solving, language and sensory-motor skill. Particular significance has been attached to these deficits as their severity has been linked to impaired community function, social problem-solving and progress in psychosocial rehabilitation programs. Cognitive remediation (CR) is a type of behavioral intervention that addresses cognitive deficits in schizophrenia by restoring lost cognitive skills or providing strategies for bypassing deficits through task practice. Meta-analyses have revealed that cognitive remediation is a validated approach to improving cognitive function in schizophrenia, however a lack of precision regarding the active elements of the intervention have prevented its recommendation as a standard treatment for the illness. The present three-year proposal seeks to identify cognitive training mechanisms that are most effective at improving cognitive function in schizophrenia by comparing two different systematic programs of CR with different foci: drill-and-practice exercises vs. compensatory strategies. Both programs have strong preliminary empirical support. One-hundred and thirty-five clients diagnosed with schizophrenia or schizoaffective disorder will be randomly assigned to one of three groups: a neuroplasticity-based, drill-and-practice program of computer-assisted cognitive training exercises designed to restore lost cognitive capacity; a manualized strategy training method for bypassing deficits in cognition, or a computer games control condition. Study measures, organized according to an experimental therapeutics approach, with targets distinguished from outcomes, will assess generalization of any observed training effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Cognitive remediation (CR) is a type of behavioral intervention that addresses cognitive deficits in schizophrenia by restoring lost cognitive skills or providing strategies for bypassing deficits through task practice. The present project seeks to identify cognitive training mechanisms that are most effective at improving cognitive function in schizophrenia by comparing two different systematic programs of CR with different foci: drill-and-practice exercises vs. compensatory strategies.
| Arm | Type | Receives |
|---|---|---|
| Restorative CR Intervention | Experimental | Behavioral: Cognitive RemediationThe restorative remediation intervention will consist of a target of 50 hours (5 hours per week, 1 hour per day, over 3 months) of a sequence of computerized cognitive exercises designed to improve cognitive function through repeated drill-and-practice of exercises largely focused on attention, working memory and verbal episodic memory. Cognitive deficits will be directly targeted by these exercises. Exercises will be started at individually determined levels of difficulty at which each client will be successful, e.g., 80% accuracy. Task difficulty will be increased as performance improves. |
| Strategy CR Intervention | Experimental | Behavioral: Cognitive RemediationParticipants in this intervention will be treated for 24 hours (2 hours per week, one day per week over 3 months) with Compensatory Cognitive Training (CCT). The therapy targets four cognitive domains: (a) prospective memory, (b) attention and vigilance, (c) learning and memory, and (d) executive function. The program is a group-based intervention that teaches strategies via interactive, game-like activities to maintain interest and enhance motivation and engagement. |
| Computer Games | Placebo comparator | Behavioral: Computer GamesThree months of 1-hour, 5-times per week, client-selected computer games. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meeting DSM-5 criteria for schizophrenia or schizoaffective disorder, presenting for intensive outpatient clinical care.
- Stabilized on atypical antipsychotic medication for a minimum of 2 months prior to entry into the protocol.
- A minimum of 2 months since discharge from last hospitalization.
- -
Key exclusion criteria (8 listed)
- Uncorrected auditory or visual impairment.
- Mental retardation (Full Scale IQ<70, as estimated by single word-reading from the WRAT and/or evidence of a history of services).
- Traumatic brain injury with loss of consciousness for more than 10 minutes.
- Presence or history of any neurologic illness.
- Lack of proficiency in English
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 |
|---|---|---|
| Cognitive RemediationCognitive remediation (CR) is a behavioral treatment designed to address neurocognitive deficits through task practice and/or strategy acquisition. | Behavioural | Restorative CR Intervention, Strategy CR Intervention |
| Computer GamesSham placebo treatment | Behavioural | Computer Games |
Primary outcome
Matrics Consensus Cognitive Battery score (MCCB composite score)
Time frame: Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
The MCCB includes state-of-the-art cognitive probes selected by 74 experts using the RAND panel method. The battery has strong reliability in schizophrenia and includes multiple forms for many subtests to help control for practice effects. Summary T-scores range from 20 to 80 with higher scores indicating better cognitive performance.
UCSD Performance-Based Skills Assessment
Time frame: Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
This standardized performance-based instrument of everyday function, with evidence of reliability and validity in schizophrenia samples, provides information regarding patients' ability to manage information/planning, finance, communications, mobility and household management in role-play situations.Scores range from 0-20 with higher scores indicating better functioning.
Quality of Life Scale
Time frame: Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.
A 21-item scale commonly used as a measure of psychosocial functioning in schizophrenia. The Quality-of-Life Scale balances subjective questions regarding life satisfaction and objective indicators of social and occupational role functioning.Scores range from 0-42 with higher scores indicating better functioning.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation and Computer Games in people with Schizophrenia and Schizoaffective Disorder, run by Wesleyan University at 2 sites 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 8 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: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Matrics Consensus Cognitive Battery score (MCCB composite score) (time frame: Measures change from study entry, after 3-months of treatment and at a 3-month follow-up.). The study lists 3 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 14 Aug 2020.