Clinical trial NCT04773171: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia; Psychosis
Cognitive Impairment
Executive Function
Randomized Controlled Trial
Efficacy
Keywords: Randomized Controlled Trial
Computer-assisted Cognitive Remediation
Executive Function
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of Wisconsin Card Sorting Test Score
timeFrame: Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment
measure: Change of The Digit Span Test Score (Digit Span Forward and Digit Span Backward)
timeFrame: Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment
measure: Change of Cognitive scores in the cognitive remediation programme CogniPlus®
timeFrame: Through study completion, an average of 12 weeks
measure: Change of Role Functioning Scale
timeFrame: Baseline, after completion of half of the programme (an average of 6 weeks), one month post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: New Life Psychiatric Rehabilitation Association
Study officials:
affiliation: The Hong Kong Polytechnic University
name: David Man, PhD
role: PRINCIPAL_INVESTIGATOR
References: