Effects of cognitive rehabilitation based on computer tasks on cognitive dysfunction in patients with Schizophrenia
Design
Clinical trial with control and parallel groups, randomized and not blinded
Settings and conduct
This study will be performed on 30 patients with schizophrenia referring to Ibn-e-Sina psychiatric Hospital. Patients are randomly assigned one of the two groups of control and intervention. Patients in both groups are prescribed medication and attend psychological skills training session for schizophrenia for 8 weeks. In the intervention group, in addition to medication, patients receive cognitive rehabilitation based on computer tasks. Before and after the interventions in both groups, cognitive assessment tests are performed and the results and the effectiveness of each group are compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with schizophrenia between 18 and 60 years; patients must be deficient in several cognitive domains; the patient has no other problem or psychiatric disorder; the patient does not have a record of proven mental disability; the patient has not received Electroconvulsive therapy in the past year; the patient has the ability to read and write. Exclusion criteria: pregnancy and breastfeeding
Intervention groups
In both groups, patients in remission and stabilization phase of the disease receive the medication prescribed by the psychiatrist for eight weeks. Also, psychological skills training for schizophrenia will be done twice a week for 10 minutes in both groups. In the intervention group, cognitive exercises using Captain's Log computer software will be done twice a week for 20 minutes each session and in the control group, 20-minute videos containing images of landscapes will be played each session.
Main outcome variables
Cognitive functions, memory, attention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101130005280N36
Registration date:2021-05-05, 1400/02/15
Registration timing:prospective
Last update:2021-05-05, 1400/02/15
Update count:0
Registration date
2021-05-05, 1400/02/15
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of cognitive rehabilitation based on computer tasks on cognitive dysfunction in patients with Schizophrenia
Public title
Effects of computer tasks on improvement of cognitive functions in schizophrenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with schizophrenia between 18 and 60 years
Patients must be deficient in several cognitive domains.
The patient has no other problem or psychiatric disorder.
The patient does not have a record of proven mental disability
The patient has not received Electroconvulsive therapy in the past year.
The patient has the ability to read and write.
Exclusion criteria:
Pregnancy and breastfeeding.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The envelopes will be prepared by one of the members of the research team and the random numbers generated by the ''www.randomization.com'' website will be printed and placed in each envelope. The envelopes are sealed and their contents are not visible from outside. At first, purpose of the study is explained for each participants and after filling out the consent form, each participant selects an envelope and opens it and based on its content, the participant will be placed in either control or intervention group.
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 Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.555
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Cognitive functions
Timepoint
At the beginning of the intervention, week 4, week 8 (end on intervention), week 12 & week 20 after the intervention
Method of measurement
Stroop test
2
Description
Memory
Timepoint
At the beginning of the intervention, week 4, week 8 (end on intervention), week 12 & week 20 after the intervention
Method of measurement
Rey auditory verbal learning test and Rey–Osterrieth complex figure test
3
Description
Attention
Timepoint
At the beginning of the intervention, week 4, week 8 (end on intervention), week 12 & week 20 after the intervention
Method of measurement
Digit span test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In this group, patients who are in remission and stabilization phase of the disease receive the medication prescribed by the psychiatrist for eight weeks. Also, psycho-educational programs and classes for schizophrenic patients will be held twice a week for 8 weeks. Each session lasts 10 minutes and each week, one of the 8 topics of "introduction to schizophrenia, causes of the disease, treatment, ways to deal with the recurrence of the disease, dealing with hallucinations, problem-solving, cognitive improvement and leisure time" are explained. In addition, a 20-minute video containing images of landscapes will be played each session.
Category
Treatment - Drugs
2
Description
Intervention group: In this group, patients who are in remission and stabilization phase of the disease receive the medication prescribed by the psychiatrist for eight weeks. Also, psycho-educational programs and classes for schizophrenic patients will be held twice a week for 8 weeks. Each session lasts 10 minutes and each week, one of the 8 topics of "introduction to schizophrenia, causes of the disease, treatment, ways to deal with the recurrence of the disease, dealing with hallucinations, problem-solving, cognitive improvement and leisure time" are explained. In addition, cognitive exercises using Captain's Log computer software will be done twice a week for 20 minutes each session to develop cognitive skills. This software includes training on attention skills using "Drum Signals" and "Musical Pairs" tests and memory skills using "What's Next" and "Match Play" tests.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-e-Sina psychiatric Hospital
Full name of responsible person
Dr. Farhad Faridhoseini
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue,boo Ali square
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 3711 2540
Email
faridhoseinif@mums.ac.ir
2
Recruitment center
Name of recruitment center
Hejazi Psychiatric Hospital
Full name of responsible person
Dr. Farhad Faridhoseini
Street address
Hejazi psychiatric hospital, after Majlesi crossroad, Mashhad, Ebadi Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3732 6767
Email
faridhoseinif@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Bahareh Hakimi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ebn-e-sina hospital. Hore Ameli blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 1711 2540
Fax
Email
Hakimib971@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Farhad Faridhoseini
Position
Assistant Pofessor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn-e-Sina Hospital, Hore Ameli blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 3711 2721
Fax
Email
faridhoseinif@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Farhad Faridhoseini
Position
Assistant Pofessor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn-e-Sina Hospital, Hore Ameli blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
8313491959
Phone
+98 51 3711 2721
Fax
Email
faridhoseinif@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available