Condition category
Mental and Behavioural Disorders
Date applied
10/08/2017
Date assigned
17/08/2017
Last edited
17/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Psychosis is a mental health problem that causes people to perceive or interpret things differently from those around them, and might involve hallucinations or delusions. Schizophrenia is a type of psychosis. Functional and recovery outcomes are poor in patients with schizophrenia in terms of work, their self-care and their relationships. Cognitive remediation therapy (CRT) is a type of rehabilitation treatment that aims to improve abilities such as attention and memory. Most findings on CRT challenge the assumption that simply improving cognitive functioning in schizophrenia will spontaneously lead to better outcomes. The aim of this study is to find out whether adjunct CRT (A-NEAR) is better than conventional CRT at improving cognitive functioning in first episode psychosis patients.

Who can participate?
First-episode psychosis patients aged 18 to 40

What does the study involve?
During the first visit, participants answer a set of questionnaires and attempt a cognitive test. Participants are randomly allocated to adjunct CRT (A-NEAR) or conventional CRT for 15 sessions over 8 weeks. The questionnaires are repeated after the treatment sessions to measure the difference in cognitive functioning. Participation in this study takes about two months with three months follow-up.

What are the possible benefits of participating?
Participants gain knowledge about cognition and schizophrenia, recovery and cognitive skills. There are no known risks and/or discomforts associated with the treatment in this study.

Where is the study run from?
Hospital Putrajaya, Hospital Kajang, Hospital Kuala Lumpur and UKM Medical Centre (Malaysia)

When is the study starting and how long is it expected to run for?
February 2016 to August 2018

Who is funding the study?
Public Service Department of Malaysia

Who is the main contact?
1. Mrs Naniyati Shuib (public)
nani.shuib@gmail.com
2. Dr Mahadir Ahmad (scientific)
mahadir@ukm.edu.my

Trial website

Contact information

Type

Public

Primary contact

Mrs Naniyati Shuib

ORCID ID

Contact details

Universiti Kebangsaan Malaysia
Faculty of Health Sciences
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
+60 (0)326 878 168
nani.shuib@gmail.com

Type

Scientific

Additional contact

Dr Mahadir Ahmad

ORCID ID

Contact details

Universiti Kebangsaan Malaysia
Faculty of Health Sciences
Jalan Raja Muda Abdul Aziz
Kuala Lumpur
50300
Malaysia
+60 (0)326 878 168
mahadir@ukm.edu.my

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NMRR29797

Study information

Scientific title

The efficacy of cognitive remediation on processing speed in patients with first episode psychosis: a randomized controlled trial

Acronym

Study hypothesis

To evaluate whether the adjunct CRT (A-NEAR) is superior to conventional CRT in improving global cognitive functioning in first episode psychosis (FEP) patients.

Ethics approval

1. Malaysia ethics board (NMRR) through Medical Research Ethics Committee (MREC), Ministry of Health, Malaysia, 01/06/2016, ref: NMRR-16-598-29797 (IIR)
2. Ethics Committee of Universiti Kebangsaan Malaysia, ref: (UKM)NN-2016-037

Study design

Single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Psychosis

Intervention

This single-blinded randomised controlled trial will address the efficacy of CR therapy using NEAR model by targeting processing speed in first episode psychosis. Participants’ cognition, functioning and clinical symptoms will be assessed at baseline and then randomised to treatment arm (adjunct CRT (A-NEAR)) or standard care of conventional CRT as active control for 15 sessions over 8 weeks. All participants will be assessed again at post-randomisation assessment with 3 months follow-up. A sequential mixed methods design will be used, in which the intervention will be executed in sequence followed by in-depth interview before the data could be embedded. There will be a primary outcome of improvement in global cognition and psychosocial functioning as a secondary outcome. All procedures and reporting of primary and secondary outcomes will follow Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines.

The primary purpose of ReMind study will be to execute intervention of CR with the use of quantitative instruments to test the eclectic theories of neuropsychological, learning, educational psychology and rehabilitation psychology that predict the treatment effect between independent variables of A-NEAR treatment that will influence positively the performance of cognitive domains and functional outcomes as dependent variables in patients with first episode psychosis with processing speed as mediator.

Randomisation and allocation concealment
Signed informed consent will be obtained prior to randomisation. The single blinded (masked) assessors will recruit the participants through demographic data and assessments. After a comprehensive baseline assessment, those meeting the eligibility will be randomized.

Thereafter, a randomisation is performed, the potential participants will be informed of the result of the randomisation. The patients and treatment providers will not be blinded. The blinding applies to ReMind training team involved in assessments, data management, data analysis, and drawing outcome conclusions.

Successful randomisation in practice depends on two interrelated aspects which adequate generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs. The treatment allocation system will be set up so that the person enrolling participants does not know in advance which treatment the next person will get, a process termed allocation concealment. Although there are many approaches to randomization that are known to effectively conceal the randomization sequence, the use of sequentially numbered, opaque sealed envelopes (SNOSE) will be adopted in the study as it is the most accessible and straightforward method of maintaining allocation concealment and does not require the use of specialized technology. Moreover, the method is both cheap and effective in ensuring source of bias can be eliminated by concealing the upcoming allocation sequence from researchers and participants.

For primary and secondary outcomes, the assessments will be conducted at baseline, prior to randomisation, as information from the baseline assessment is used to perform randomisation and validate inclusion and exclusion criteria. The post assessment will also be administered after 8 weeks of intervention.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Cognitive functioning, assessed by neurocognitive assessment through The Brief Assessment of Cognition in Schizophrenia (BACS) at baseline and 8 weeks

Secondary outcome measures

Functional outcomes, assessed using functional measures including Schizophrenia Cognition Rating Scale (SCoRS), Social Functioning Scale (SFS), Social and Occupational Functioning Assessment Scale (SOFAS) and Schizophrenia Quality of Life Scale Revision 4 (SQLS-R4) at baseline and 8 weeks

Overall trial start date

08/02/2016

Overall trial end date

31/08/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. First-episode psychosis patients with schizophrenia, schizophreniform disorder or schizoaffective disorder at diagnosis and presenting with cognitive deficits
2. Young adults aged 18 to 40
3. Able to read and write in Malay and/or English
4. Written informed consent
5. Fulfil the criteria of cognitive measures, symptomatology and other functioning
6. The symptoms must have been present during the past year including other criteria

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

104

Participant exclusion criteria

1. Previous diagnosis of mental retardation, psychotic disorder related to a general medical condition or substance-induced psychotic disorder
2. Severe schizophrenia
3. History of any diagnosis of a serious developmental disorder
4. Significant ongoing neurological disorders including epilepsy
5. History of severe head injury
6. Concurrently undergoing other types of cognitive remediation therapy

Recruitment start date

01/08/2016

Recruitment end date

31/10/2017

Locations

Countries of recruitment

Malaysia

Trial participating centre

Hospital Putrajaya, Hospital Kajang, Hospital Kuala Lumpur and UKM Medical Centre
Department of Psychiatric and Mental Health
Kuala Lumpur and Selangor
62510
Malaysia

Sponsor information

Organisation

Public Service Department of Malaysia

Sponsor details

Blok C1-C3
Kompleks C Pusat Pentadbiran Kerajaan Persekutuan
Putrajaya
62510
Malaysia

Sponsor type

Government

Website

http://www.jpa.gov.my

Funders

Funder type

Government

Funder name

Jabatan Perkhidmatan Awam Malaysia

Alternative name(s)

Public Service Department of Malaysia, JPA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Malaysia

Results and Publications

Publication and dissemination plan

The data from this study will be made into a report which may be published.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Naniyati Shuib (nani.shuib@gmail.com). The data will be reported in a collective manner with no reference to an individual. Hence the identity of participants will be kept confidential. Data from the study will be archived and may be transmitted outside the country for the purpose of analysis, publishing or presenting the study results without revealing the identity of participants at any time.

Intention to publish date

15/12/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes