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Efficacy of Computer-assisted Cognitive Remediation in Patients With Schizophrenia

Primary Purpose

Schizophrenia; Psychosis, Cognitive Impairment, Executive Function

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Computer-assisted Cognitive Remediation
Conventional training programmes
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia; Psychosis focused on measuring Randomized Controlled Trial, Computer-assisted Cognitive Remediation, Executive Function

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New Life Psychiatric Rehabilitation Association

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CACR Group

TAU Group

Arm Description

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.

Participants of TAU group will attend usual training sessions offered by the training centres with similar intensity and frequency as the CACR training.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2021
Last Updated
March 2, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT04773171
Brief Title
Efficacy of Computer-assisted Cognitive Remediation in Patients With Schizophrenia
Official Title
Efficacy of Computer-assisted Cognitive Remediation in Patients With Schizophrenia: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 13, 2021 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia; Psychosis, Cognitive Impairment, Executive Function, Randomized Controlled Trial, Efficacy
Keywords
Randomized Controlled Trial, Computer-assisted Cognitive Remediation, Executive Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CACR Group
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU Group
Arm Type
Active Comparator
Arm Description
Participants of TAU group will attend usual training sessions offered by the training centres with similar intensity and frequency as the CACR training.
Intervention Type
Other
Intervention Name(s)
Computer-assisted Cognitive Remediation
Intervention Description
Drill practice and bridging activities
Intervention Type
Other
Intervention Name(s)
Conventional training programmes
Intervention Description
Existing conventional activities in the settings
Primary Outcome Measure Information:
Title
Change of Wisconsin Card Sorting Test Score
Description
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.
Time Frame
Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment
Title
Change of The Digit Span Test Score (Digit Span Forward and Digit Span Backward)
Description
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.
Time Frame
Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment
Title
Change of Cognitive scores in the cognitive remediation programme CogniPlus®
Description
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.
Time Frame
Through study completion, an average of 12 weeks
Title
Change of Role Functioning Scale
Description
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.
Time Frame
Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Man, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Life Psychiatric Rehabilitation Association
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Computer-assisted Cognitive Remediation in Patients With Schizophrenia

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