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General information
Single blinded
Double blinded
singldoubl
All patients are informed that they consent to participate in a research study. A written consent form will be completed by the participants. Statisticians and assessors are blinded to grouping.
All patients are informed that they consent to participate in a research study. A written consent form will be completed by the participants. Statisticians, assessors , and participants are blinded to grouping.
All patients are informed that they consent to participate in a research study. A written consent form will be completed by the participants. Statisticians, assessors , and assessorsparticipants are blinded to grouping.
به همه بیماران اطلاع داده می شود که رضایت در یک مطالعه تحقیقاتی شرکت خواهند کرد. فرم رضایت نامه کتبی توسط شرکت کنندگان تکمیل خواهد شد. آماریست، و ارزیاب نسبت به گروه بندی کور هستند.
به همه بیماران اطلاع داده می شود که رضایت در یک مطالعه تحقیقاتی شرکت خواهند کرد. فرم رضایت نامه کتبی توسط شرکت کنندگان تکمیل خواهد شد. آماریست، و ارزیاب, و شرکت کنندگان نسبت به گروه بندی کور هستند.
به همه بیماران اطلاع داده می شود که رضایت در یک مطالعه تحقیقاتی شرکت خواهند کرد. فرم رضایت نامه کتبی توسط شرکت کنندگان تکمیل خواهد شد. آماریست، و ارزیاب, و شرکت کنندگان نسبت به گروه بندی کور هستند.
Protocol summary
Study aim
- Investigating the cognitive performance, self-esteem, depression, and quality of life of people with schizophrenia before and after cognitive rehabilitation interventions
Design
A clinical trial with two groups including intervention and control, with a study population of 30 people (15 in the intervention group and 15 in the control group), double-blind, simple randomized using a random number table.
Settings and conduct
Participants will be randomly divided into 2 groups. Patients, and assessors, are blinded to the grouping. In addition to conventional treatments, the intervention group receives 30 sessions of computerized cognitive rehabilitation (using CANTAB software). Interventions are performed at Razi Psychiatric Hospital. The control group, in addition to common treatments, will perform non-cognitive exercises with the computer for the same period of time. Participants will be evaluated before, immediately after, and two months after the interventions with cognitive tools and questionnaires so that the effectiveness of the intervention can be carefully examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: age 18 to 55 years, diagnosis of schizophrenia, having mental capacity, and having an MMSE score higher than 18. Exclusion criteria are: suffering from medical problems that hinder sensory and motor function, changing medication during the last month or during the intervention, and suffering from paranoid hallucinations.
Intervention groups
In addition to conventional treatments, the intervention group will receive computerized cognitive rehabilitation in 30 sessions. Each intervention session includes 45 minutes of cognitive rehabilitation. The control group will also have 30 sessions of non-cognitive exercises with the computer.
Main outcome variables
Cognitive functions, Self-esteem, Quality of Life, Depression, Anxiety, Mental well-being
General information
Reason for update
The changes made are due to the conditions and facilities of research centers and research team.
Acronym
IRCT registration information
IRCT registration number:IRCT20180317039116N2
Registration date:2023-01-28, 1401/11/08
Registration timing:prospective
Last update:2024-02-15, 1402/11/26
Update count:3
Registration date
2023-01-28, 1401/11/08
Registrant information
Name
Elahe Fathi Azar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3386 1366
Email address
el.fathiazar@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-06-06, 1402/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of computer-assisted cognitive rehabilitation on cognitive functions, and mental health of people with schizophrenia
Public title
The effects of computer-assisted cognitive rehabilitation on cognitive functions, and mental health of people with schizophrenia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Schizophrenia disorder diagnosed based on DSM-V by a psychiatrist
Having an MMSE score above 18
Age 18 to 55 years
Exclusion criteria:
Having mental retardation
Orthopedic, neurological problems that prevent upper limb function
Changing the medication regimen during the last month or during the intervention
Having paranoid delusions
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The simple randomization method using random number tables will be used. for allocation concealment Sequentially numbered, sealed, opaque envelopes will be used for this process: The random numbers are placed in the opaque envelopes and the allocation of these opaque envelopes to groups is done randomly, this allocation is confidential and without informing the executor, patient, and investigators.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients are informed that they consent to participate in a research study. A written consent form will be completed by the participants. Statisticians, assessors , and participants are blinded to grouping.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of social Welfare and Rehabilitation Sciences
Street address
University of social welfare and rehabilitation sciences, Kodakyar Alley, Daneshjo Blv. Evin, Tehran.
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.USWR.REC.1401.199
Health conditions studied
1
Description of health condition studied
Cognitive impairments in Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Visual memory: Visual memory is a type of memory that refers to the ability to recall or remember activities, images, positions of objects or words in the past. Visual memory includes the ability to store and retrieve visual sensations and perceptions previously experienced by the individual.
Timepoint
Before the start of the intervention (at the beginning of the study), after receiving the intervention, and two months after the end of the intervention period
Method of measurement
PAL, SRM, SWM, and SSP subtests of CANTAB
2
Description
Problem Solving: Problem solving is part of thinking. Problem solving, which is considered the most complex part of any intellectual operation, is defined as an important cognitive process that requires the integration and control of a series of basic and ordinary skills.
Timepoint
Before the start of the intervention (at the beginning of the study), after receiving the intervention, and two months after the end of the intervention period
Method of measurement
SOC subtest of CANTAB
3
Description
Self-esteem: Self-esteem is the belief that a person has about her worth and importance.
Timepoint
Before the start of the intervention (at the beginning of the study), after receiving the intervention, and two months after the end of the intervention period
Method of measurement
Using Cooper-Smith self-esteem inventory (SEI)
4
Description
Depression is a mood state that includes boredom and avoidance of activity or apathy and reluctance and can affect a person's thoughts, behavior, feelings, happiness and well-being.
Timepoint
Before the start of the intervention (at the beginning of the study), after receiving the intervention, and two months after the end of the intervention period
Method of measurement
Using Beck Depression short Inventory (BDI-S)
5
Description
Quality of life: Quality of life is defined as people's understanding of their position in life in the context of the culture and value systems in which they live and in relation to their own goals, expectations, standards and concerns.
Timepoint
Before the start of the intervention (at the beginning of the study), after receiving the intervention, and two months after the end of the intervention period
Method of measurement
Using The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
6
Description
Mental health is a fundamental and comprehensive factor in the health and life of every person. The World Health Organization (WHO) states:"Health means physical, mental and social well-being and not merely the absence of disease or disability".An important application of this definition is that mental health is more than just the absence of mental disorders or disabilities.
Timepoint
Before the start of the intervention (at the beginning of the study), after receiving the intervention, and two months after the end of the
Method of measurement
Warwick-Edinburgh Mental Well-Being Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to receiving conventional services (doctor, psychologist, and occupational therapist consultation), this group receives computerized cognitive rehabilitation 3 days a week (30 sessions in total). Using the CANTAB cognitive test set, computerized cognitive rehabilitation is performed in 45-minute sessions. This rehabilitation includes the practice of 4 subtests DMS, MTS, OTS, and PRM from CANTAB, which becomes more complex as time passes. For example, as the stage increases, the number of variables and response time changes, and it is expected that the accuracy and speed of the person's action will be affected accordingly. The purpose of DMS, MTS, and PRM exercises is to involve several cognitive processes related to memory and visual-spatial attention. OTS targets planning, problem-solving, and executive functions. All the people in this group are evaluated cognitively and psychologically before, immediately after, and two months after the interventions, in order to evaluate the effectiveness of the intervention in improving the cognitive and mental health of people.
Category
Rehabilitation
2
Description
Control group: Participants in this group will receive treatment as usual such as psychiatrist, psychologist and occupational therapist visits for 30 sessions of 45 minutes (3 sessions per week).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi psychiatric hospital
Full name of responsible person
Elahe Fathi Azar
Street address
Shahid Rastegar Blv., Shahre Rey, Tehran
City
Tehran
Province
Tehran
Postal code
18664
Phone
+98 21 3340 1226
Email
Elahe_fathi91@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hooshang Mirzaei
Street address
university of social welfare and rehabilitation sciences, Daneshjo Blv. Evin
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0083
Email
Elahe_fathi91@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
50
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 social welfare and rehabilitation sciences
Full name of responsible person
Hooshang Mirzaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
university of social welfare and rehabilitation sciences
City
تهران
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0083
Email
Elahe_fathi91@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hooshang Mirzaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
university of social welfare and rehabilitation sciences
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0083
Email
Elahe_fathi91@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences