The efficacy of computerized cognitive rehabilitation on improving cognitive deficits and positive and negative symptoms of people diagnosed with schizophrenia
Determining the effectiveness of computer-based cognitive rehabilitation on improving cognitive deficits and positive and negative symptoms of patients with schizophrenia
Design
A number of 30 patients with schizophrenia hospitalized in the treatment and rehabilitation center for mental patients will be selected by purposeful sampling method and will be randomly assigned to two experimental and control groups.
Settings and conduct
Schizophrenia patients in Ardabil mental patients treatment center will be selected by purposive sampling method. Subjects will be randomly divided into two experimental and control groups, and the computer-based cognitive rehabilitation program using Captain Log cognitive software, during 12 sessions for The experimental group will be implemented.
Participants/Inclusion and exclusion criteria
In this study, the criteria for selecting patients is a definite diagnosis of schizophrenia based on the psychiatrist's diagnosis and based on the criteria of DSM-5. Entry criteria include minimum reading and writing literacy, not suffering from brain damage, dementia and special neurological disease that requires special care, not receiving electroshock for at least 6 months before the study and during the treatment period, not abusing any type of narcotic or stimulant. It has been in the past month. Contradiction with any of the mentioned criteria, absence of more than three sessions and the patient's unwillingness to continue the sessions will cause the patient to leave the study.
Intervention groups
The computer-based cognitive rehabilitation program will be implemented for the experimental group during 12 sessions and for 45 minutes using Captain Log cognitive software.
Main outcome variables
It is assumed that computer-based cognitive rehabilitation has an effect on improving cognitive deficits and positive and negative symptoms of patients with schizophrenia.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240521061854N1
Registration date:2024-06-08, 1403/03/19
Registration timing:prospective
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
Registrant information
Name
Mahdis Alaei Kalajahi
Name of organization / entity
The University of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 914 928 3918
Email address
mahdisalaei@student.uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-09, 1403/03/20
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of computerized cognitive rehabilitation on improving cognitive deficits and positive and negative symptoms of people diagnosed with schizophrenia
Public title
The efficacy of computerized cognitive rehabilitation symptoms of people diagnosed with schizophrenia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of schizophrenia based on psychiatrist's diagnosis and DSM-5 criteria
Minimum literacy for patients
Not suffering from brain damage, dementia and special neurological disease that requires special care
Not receiving electroconvulsive therapy at least 6 months before the study and during the treatment
Not abusing any type of drug or stimulant during the past month
Abusing any type of drug or stimulant during the past month
Exclusion criteria:
Illiteracy of patients
Any brain damage, dementia and specific neurological disease of the patient that needs special care
Receiving electroshock at least 6 months before the study and during the treatment
Abusing any type of drug or stimulant during the past month
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups based on permuted block randomization, including the intervention group (receiving cognitive rehabilitation intervention) and the control group (not receiving cognitive rehabilitation intervention). The people of the two groups will be matched in terms of age, education and disease severity.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Mohaghegh Ardebili
Street address
Daneshgah st. University of Mohaghegh Ardebili
City
Ardebil
Province
Ardabil
Postal code
5619911367
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.UMA.REC.1403.016
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Computer-based cognitive rehabilitation has an effect on improving cognitive deficits such as visual and auditory active memory, continuous and selective attention of patients with schizophrenia.
Timepoint
Measuring cognitive functions and positive and negative symptoms of schizophrenia before the start of the intervention and 1.5 and 4 months after the start of rehabilitation
Method of measurement
Montreal Cognitive Assessment, n -back task, Continuous Performance Test, simple stroop test
Secondary outcomes
1
Description
Computer-based cognitive rehabilitation is effective in reducing positive and negative symptoms of patients with schizophrenia.
Timepoint
Measurement of positive and negative symptoms of schizophrenia before the start of the intervention and 1.5 and 4 months after the start of rehabilitation.
Method of measurement
Positive and Negative Syndrome Scale
Intervention groups
1
Description
Intervention group: The computer-based cognitive rehabilitation program will be implemented using Captain Log cognitive software, during 12 sessions and for 45 minutes, including exercises related to strengthening visual and auditory working memory, strengthening selective and continuous attention, strengthening processing speed and cognitive flexibility for the experimental group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Darulshafa Center for Treatment and Rehabilitation of Chronic Mental Patients
Full name of responsible person
Akbar Atadokht
Street address
Valiasr town, Miyad Boulevard, Irannejad St
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3358 6236
Email
ak_atadokht@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Jabraeil Razmjou
Street address
Daneshgah st, University of Mohaghegh Ardabili
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5000
Email
info@uma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Mohaghegh Ardabili
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Mahdis Alaei Kalajahi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Daneshgah st, University of Mohaghegh Ardabili
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 41 3478 7055
Email
mahdisalaeikl@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Mahdis Alaei Kalajahi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Danesgah st, University of Mohaghegh Ardabili
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 41 3478 7055
Email
mahdisalaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Mahdis Alaei Kalajahi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Daneshgah st, University of Mohaghegh Ardabili
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 41 3478 7055
Email
mahdisalaeikl@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data related to the outcome variable and scored and statistically analyzed will be shared and not other personal information.
When the data will become available and for how long
The access period starts one year after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions and people working in treatment and rehabilitation centers for neurological and mental patients.
Under which criteria data/document could be used
For researchers to benefit from scientific data obtained from research and use them in treatment
From where data/document is obtainable
After uploading, refer to the scientific databases to get the results and data.
What processes are involved for a request to access data/document
To receive data, refer to the e-mail of the researcher.