Schizophrenia; PsychosisNCT04773171
Efficacy of Computer-assisted Cognitive Remediation in Patients With Schizophrenia
A study testing Computer-assisted Cognitive Remediation and Conventional training programmes in people with Schizophrenia; Psychosis and Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Objective: To determine the efficacy of computer-assisted cognitive remediation (CACR) in patients with chronic schizophrenia in the community settings. Study Design: Single-blinded prospective, pre-test/post-test randomized controlled trial (RCT) will be conducted in 2 groups of participants that receiving training… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia; Psychosis, Cognitive Impairment, Executive Function
- What is being tested?
- Computer-assisted Cognitive Remediation and Conventional training programmes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Apr 2021to 30 Nov 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia, based on Diagnostic and statistical manual of mental disorders (5th ed.), at chronic and stable state
- Age from 18 to 64
- Regular attendance to rehabilitation training programmes
- Willing and capable to participate and are voluntarily consent to the participation
- Pass the cut-off point of referenced screening tests
Who cannot join
- Comorbid differential diagnosis
- History of organic brain disorder
- Complicated conditions that preclude regular attendance of the training
- Currently receiving computer-assisted cognitive remediation and other individual intensive cognitive training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Computer-assisted Cognitive Remediation in Patients With Schizophrenia: A Randomized Controlled Trial
Objective: To determine the efficacy of computer-assisted cognitive remediation (CACR) in patients with chronic schizophrenia in the community settings.
Study Design: Single-blinded prospective, pre-test/post-test randomized controlled trial (RCT) will be conducted in 2 groups of participants that receiving training in community settings. Treatment groups will attend individualized CACR programme using CogniPlus® while control group will continue attend conventional treatment as usual (TAU). Assessment on the means difference in assessing functions will be done after the study.
Read more
Samples: 80 patients with stable and chronic schizophrenia will be recruited from the community, using a sampling frame of selected diagnosis and homogeneity.
Expected Findings: Find out the training effects of selected CACR on EF and daily functioning in patients with schizophrenia.
Read the detailed description
Schizophrenia is one of the most serious and disabling mental disorders. Prevalence of schizophrenia is about 1% worldwide. The related dysfunctions have great impact and burden to the concerned person and to the society. With increasing use of CR programmes in helping the patients to resume their capability in community living, the clinical outcome was not fully established especially on specific cognitive domains such as executive function (EF). The present study aims at evaluating the efficacy of CACR on developing EF and improving daily functioning. The result will provide information for therapists' future clinical decisions for patients' best reintegration into the societies. This also helps decrease the burden of family, society in the long run.
- Conditions
- Schizophrenia; Psychosis, Cognitive Impairment, Executive Function, Randomized Controlled Trial, Efficacy
- Being tested
- Computer-assisted Cognitive Remediation, Conventional training programmes
- Keywords
- Randomized Controlled Trial, Computer-assisted Cognitive Remediation, Executive Function
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted Cognitive RemediationOther
Drill practice and bridging activities
Conventional training programmesOther
Existing conventional activities in the settings
| Study group | Role | What they receive |
|---|---|---|
| CACR Group | Experimental | Participants of CACR group will attend individual computer-assisted cognitive remediation sessions. Researcher will give instruction in the use of the computerized training programs and assists participants during their training sessions. Receives: Other: Computer-assisted Cognitive Remediation |
| TAU Group | Active comparator | Participants of TAU group will attend usual training sessions offered by the training centres with similar intensity and frequency as the CACR training. Receives: Other: Conventional training programmes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Wisconsin Card Sorting Test Score
It is a neuropsychological test that is used to measure high-level cognitive processes as attention, perseverance, working memory, abstract thinking, cognitive flexibility, and set shifting.
The test consists of 128 card designs, participant is required to sort the cards under the categorization rules and feedback from examiner in about 20 minutes. The more categories achieved (range 0 to 6) and less perseverative errors (out of 128 trials) the better executive control. Moreover, the lower the total number of trials administered (total number of cards used) reflects greater efficiency of the participant in the task; in addition, the greater the total number of correct responses (number of successes in combinations according to the category) and the lower the total number of errors (number of incorrect combinations) also indicate the better the participant's performance.
Measured: Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment
Change of The Digit Span Test Score (Digit Span Forward and Digit Span Backward)
It measures a participant's attention and working memory. Forward span captures attention capacity and backward span reflects working memory. The higher both the scores the better functioning. Participant repeats or reverses the digit sequencing after the examiner read out lists of random numbers, extra digit would be added for increased level of difficulty with two trials per level until the participant gives out incorrect answer. Average adult score for forward span is eight to ten and seven to nine for backward span.
Measured: Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment
Change of Cognitive scores in the cognitive remediation programme CogniPlus®
There are 15 individual training modules that grouped into 6 function dimensions (attention, neglect/visual field training, memory, executive function, spatial processing and visuomotor skills) in this programme.
Different number of difficulty levels and specific requirements are structured in different modules. For example, DATEUP module in memory dimension contains 25 levels, incremented with increasing number of stimuli that move in higher speed for the participants to retain and update the information; while ALERT module in attention dimension have 18 difficulty levels, with decreasing maximum permitted reaction time for the participants to respond.
For the evaluations of results in all modules, the higher percentage of correct response, the shorter reaction/working time and the higher difficulty level attained indicate the better corresponding functioning. The importance of these cognitive scores is to help tracking the participants' task functioning throughout the study.
Measured: Through study completion, an average of 12 weeks
Change of Role Functioning Scale
It is a measure of functioning level of adults in four domains: working productivity, independent living/self-care, immediate social network relationships and extended social network relationships.
7-point scale for the four domains and their total score (ranging from 4 to 28) represent the Global Role Functioning Index, the higher scores the better the person's functioning.
Measured: Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start13 Apr 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia; PsychosisStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Man, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773171
- Sponsor's protocol ID
- HongKongPUDA
- Status last verified
- Mar 2023
- First submitted
- 8 Feb 2021
- Last updated
- 6 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Computer-assisted Cognitive Remediation in Patients With Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04773171
- Acronym / sponsor ID
- HongKongPUDA
- Conditions
- Schizophrenia; Psychosis, Cognitive Impairment, Executive Function, Randomized Controlled Trial, Efficacy
- Keywords
- Randomized Controlled Trial, Computer-assisted Cognitive Remediation, Executive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 26 Feb 2021 (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.
Objective: To determine the efficacy of computer-assisted cognitive remediation (CACR) in patients with chronic schizophrenia in the community settings.
Study Design: Single-blinded prospective, pre-test/post-test randomized controlled trial (RCT) will be conducted in 2 groups of participants that receiving training in community settings. Treatment groups will attend individualized CACR programme using CogniPlus® while control group will continue attend conventional treatment as usual (TAU). Assessment on the means difference in assessing functions will be done after the study.
Samples: 80 patients with stable and chronic schizophrenia will be recruited from the community, using a sampling frame of selected diagnosis and homogeneity.
Expected Findings: Find out the training effects of selected CACR on EF and daily functioning in patients with schizophrenia.
Detailed description
Schizophrenia is one of the most serious and disabling mental disorders. Prevalence of schizophrenia is about 1% worldwide. The related dysfunctions have great impact and burden to the concerned person and to the society. With increasing use of CR programmes in helping the patients to resume their capability in community living, the clinical outcome was not fully established especially on specific cognitive domains such as executive function (EF). The present study aims at evaluating the efficacy of CACR on developing EF and improving daily functioning. The result will provide information for therapists' future clinical decisions for patients' best reintegration into the societies. This also helps decrease the burden of family, society in the long run.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CACR Group | Experimental | Other: Computer-assisted Cognitive RemediationParticipants of CACR group will attend individual computer-assisted cognitive remediation sessions. Researcher will give instruction in the use of the computerized training programs and assists participants during their training sessions. |
| TAU Group | Active comparator | Other: Conventional training programmesParticipants of TAU group will attend usual training sessions offered by the training centres with similar intensity and frequency as the CACR training. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of schizophrenia, based on Diagnostic and statistical manual of mental disorders (5th ed.), at chronic and stable state
- Age from 18 to 64
- Regular attendance to rehabilitation training programmes
- Willing and capable to participate and are voluntarily consent to the participation
- Pass the cut-off point of referenced screening tests
Key exclusion criteria (4 listed)
- Comorbid differential diagnosis
- History of organic brain disorder
- Complicated conditions that preclude regular attendance of the training
- Currently receiving computer-assisted cognitive remediation and other individual intensive cognitive training
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 |
|---|---|---|
| Computer-assisted Cognitive RemediationDrill practice and bridging activities | Other | CACR Group |
| Conventional training programmesExisting conventional activities in the settings | Other | TAU Group |
Primary outcome
Change of Wisconsin Card Sorting Test Score
Time frame: Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment
It is a neuropsychological test that is used to measure high-level cognitive processes as attention, perseverance, working memory, abstract thinking, cognitive flexibility, and set shifting. The test consists of 128 card designs, participant is required to sort the cards under the categorization rules and feedback from examiner in about 20 minutes. The more categories achieved (range 0 to 6) and less perseverative errors (out of 128 trials) the better executive control. Moreover, the lower the total number of trials administered (total number of cards used) reflects greater efficiency of the participant in the task; in addition, the greater the total number of correct responses (number of successes in combinations according to the category) and the lower the total number of errors (number of incorrect combinations) also indicate the better the participant's performance.
Change of The Digit Span Test Score (Digit Span Forward and Digit Span Backward)
Time frame: Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment
It measures a participant's attention and working memory. Forward span captures attention capacity and backward span reflects working memory. The higher both the scores the better functioning. Participant repeats or reverses the digit sequencing after the examiner read out lists of random numbers, extra digit would be added for increased level of difficulty with two trials per level until the participant gives out incorrect answer. Average adult score for forward span is eight to ten and seven to nine for backward span.
Change of Cognitive scores in the cognitive remediation programme CogniPlus®
Time frame: Through study completion, an average of 12 weeks
There are 15 individual training modules that grouped into 6 function dimensions (attention, neglect/visual field training, memory, executive function, spatial processing and visuomotor skills) in this programme. Different number of difficulty levels and specific requirements are structured in different modules. For example, DATEUP module in memory dimension contains 25 levels, incremented with increasing number of stimuli that move in higher speed for the participants to retain and update the information; while ALERT module in attention dimension have 18 difficulty levels, with decreasing maximum permitted reaction time for the participants to respond. For the evaluations of results in all modules, the higher percentage of correct response, the shorter reaction/working time and the higher difficulty level attained indicate the better corresponding functioning. The importance of these cognitive scores is to help tracking the participants' task functioning throughout the study.
Change of Role Functioning Scale
Time frame: Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment
It is a measure of functioning level of adults in four domains: working productivity, independent living/self-care, immediate social network relationships and extended social network relationships. 7-point scale for the four domains and their total score (ranging from 4 to 28) represent the Global Role Functioning Index, the higher scores the better the person's functioning.
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 6 Mar 2023.
- Individual participant dataSharing planned: No
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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.
David Man, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted Cognitive Remediation and Conventional training programmes in people with Schizophrenia; Psychosis and Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 5 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 6 Mar 2023. 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 Hong Kong. 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 of Wisconsin Card Sorting Test Score (time frame: Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment). 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 6 Mar 2023.