Efficacy of Computer-assisted Cognitive Remediation in Patients With Schizophrenia

March 2, 2023 updated by: The Hong Kong Polytechnic University

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • New Life Psychiatric Rehabilitation Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CACR Group
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.
Other: Computer-assisted Cognitive Remediation
Drill practice and bridging activities
Active Comparator: TAU Group
Participants of TAU group will attend usual training sessions offered by the training centres with similar intensity and frequency as the CACR training.
Other: Conventional training programmes
Existing conventional activities in the settings

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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®
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.
Through study completion, an average of 12 weeks
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.
Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: David Man, PhD, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HongKongPUDA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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