Efficacy of Computer-assisted Cognitive Remediation in Patients With Schizophrenia

NCT ID: NCT04773171

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-13
• Study Completion Date: 2022-11-30

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.

Conditions

Schizophrenia; Psychosis; Cognitive Impairment; Executive Function; Randomized Controlled Trial; Efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Computer-assisted Cognitive Remediation

Intervention Type: OTHER

Drill practice and bridging activities

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.

Group Type: ACTIVE_COMPARATOR

Conventional training programmes

Intervention Type: OTHER

Existing conventional activities in the settings

Interventions

Computer-assisted Cognitive Remediation

Drill practice and bridging activities

Intervention Type: OTHER

Conventional training programmes

Existing conventional activities in the settings

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Man, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

New Life Psychiatric Rehabilitation Association

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

HongKongPUDA

Identifier Type: -

Identifier Source: org_study_id