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Investigating the effects of computer-assisted cognitive rehabilitation on cognitive functions, and mental health of people with schizophrenia

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History
# Registration date Revision Id
4 2025-07-20, 1404/04/29 348356
3 2024-02-14, 1402/11/25 294579
2 2023-08-30, 1402/06/08 278781
1 2023-01-28, 1401/11/08 254016
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  • Primary outcomes

    #1
    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
    Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the intervention period
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و دو ماه پس از اتمام دوره مداخله
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و سه ماه پس از اتمام دوره مداخله
    #2
    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
    Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the intervention period
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و دو ماه پس از اتمام دوره مداخله
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و سه ماه پس از اتمام دوره مداخله
    #3
    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
    Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the intervention period
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و دو ماه پس از اتمام دوره مداخله
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و سه ماه پس از اتمام دوره مداخله
    #4
    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.
    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.
    افسردگی: افسردگی حالتی خلقی شامل بی‌حوصلگی و گریز از فعالیت یا بی‌علاقگی و بی‌میلی است و می‌تواند بر افکار، رفتار، احساسات وخوشی و تندرستی یک فرد تأثیر بگذارد.
    سلامت روان عاملی اساسی و جامع در سلامت و زندگی هر فردی است. سازمان بهداشت جهانی (WHO) بیان می‌کند:“سلامتی به معنای تندرستی جسمانی، روانی و اجتماعی است و نه صرفاً به معنای عدم ابتلا به بیماری یا ناتوانی”.کاربرد مهم این تعریف این است که سلامت روان چیزی فراتر از صرف عدم ابتلا به اختلالات روانی یا ناتوانایی هاست.
    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
    Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و دو ماه پس از اتمام دوره مداخله
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و سه ماه پس از اتمام دوره مداخله
    Using Beck Depression short Inventory (BDI-S)
    Warwick-Edinburgh Mental Well-Being Scale
    با استفاده از پرسشنامه افسردگی بک -فرم کوتاه(BDI-S)
    مقیاس سلامت روانی وارویک-ادینبورگ
    #5
    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.
    meaningful activities are related to mental health and well-being
    کیفیت زندگی: کیفیت زندگی به عنوان درک افراد از موقعیت خود در زندگی در متن فرهنگ و سیستم های ارزشی که در آن زندگی می کنند و در رابطه با اهداف، انتظارات، استانداردها و نگرانی های خود آنها تعریف می شود.
    معنادار بودن فعالیت با سلامت روان و بهبودی ارتباط دارد
    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
    Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و دو ماه پس از اتمام دوره مداخله
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و سه ماه پس از اتمام دوره مداخله
    Using The World Health Organization Quality of Life Brief Version (WHOQOL-BREF)
    Engagement in Meaningful Activities Survey (EMAS)
    با استفاده از پرسشنامه کیفیت زندگی سازمان جهانی بهداشت -فرم کوتاه( WHOQOL-BREF)
    مقیاس مشارکت در فعالیت های معنادار
    #6
    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.
    Recovery is not just the disappearance of symptoms, but also includes supporting the individual to live a meaningful life.
    سلامت روان عاملی اساسی و جامع در سلامت و زندگی هر فردی است. سازمان بهداشت جهانی (WHO) بیان می‌کند:“سلامتی به معنای تندرستی جسمانی، روانی و اجتماعی است و نه صرفاً به معنای عدم ابتلا به بیماری یا ناتوانی”.کاربرد مهم این تعریف این است که سلامت روان چیزی فراتر از صرف عدم ابتلا به اختلالات روانی یا ناتوانایی هاست.
    بهبودی تنها از بین رفتن علایم نیست بلکه شامل حمایت از تفراد جهت داشتن زندگی معنادار می باشد.
    Before the start of the intervention (at the beginning of the study), after receiving the intervention, and two months after the end of the
    Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و دو ماه پس از اتمام دوره مداخله
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و سه ماه پس از اتمام دوره مداخله
    Warwick-Edinburgh Mental Well-Being Scale
    Recovery Assessment Scale – Domains and Stages (RAS-DS)
    مقیاس سلامت روانی وارویک-ادینبورگ
    مقیاس ارزیابی بهبودی- حیطه ها و دامنه ها
    #7
    empty
    Basic psychological needs include autonomy, relatedness, and competence.
    empty
    نیازهای روانی اساسی شامل خودمختاری، ارتباط، و شایستگی می باشد.
    empty
    Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the
    empty
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و سه ماه پس از اتمام دوره مداخله
    empty
    Basic Needs Satisfaction in General Scale (BPNSG-S)
    empty
    مقیاس ارضای نیازهای اساسی در مقیاس کلی (BPNSG-S)
    #8
    empty
    A general mental health assessment is essential to assess the experience of psychiatric problems.
    empty
    بررسی سلامت روانی عمومی جهت ارزیابی تجربه مشکلات روانپزشکی ضروری است.
    empty
    Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the
    empty
    قبل از شروع مداخله (در ابتدای مطالعه)، پس از دریافت مداخله و سه ماه پس از اتمام دوره مداخله
    empty
    General Health Questionnaire (GHQ-12)
    empty
    پرسشنامه سلامت عمومی-12

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: 2025-07-21, 1404/04/30
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 three 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 three 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 three months after the end of the intervention period
Method of measurement
Using Cooper-Smith self-esteem inventory (SEI)

4

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 three months after the end of the
Method of measurement
Warwick-Edinburgh Mental Well-Being Scale

5

Description
meaningful activities are related to mental health and well-being
Timepoint
Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the
Method of measurement
Engagement in Meaningful Activities Survey (EMAS)

6

Description
Recovery is not just the disappearance of symptoms, but also includes supporting the individual to live a meaningful life.
Timepoint
Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the
Method of measurement
Recovery Assessment Scale – Domains and Stages (RAS-DS)

7

Description
Basic psychological needs include autonomy, relatedness, and competence.
Timepoint
Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the
Method of measurement
Basic Needs Satisfaction in General Scale (BPNSG-S)

8

Description
A general mental health assessment is essential to assess the experience of psychiatric problems.
Timepoint
Before the start of the intervention (at the beginning of the study), after receiving the intervention, and three months after the end of the
Method of measurement
General Health Questionnaire (GHQ-12)

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
Full name of responsible person
Elahe Fathi Azar
Position
MSc
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
No.51, Molavi Alley, Abomoslem Ave., Shahak masoudiye, Afsariyeh Junction.
City
Tehran
Province
Tehran
Postal code
1788917341
Phone
+98 21 3386 1366
Fax
Email
elahe_fathi91@yahoo.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
No - There is not 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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Sending all of the data, if the members of the research team agree, a decision will be made based on the applicant's goal.
When the data will become available and for how long
The second half of 1402
To whom data/document is available
First author and corresponding author
Under which criteria data/document could be used
If the members of the research team agree, a decision will be made based on the applicant's goal.
From where data/document is obtainable
Elahe Fathi Azar
What processes are involved for a request to access data/document
Sending an email to Elahe Fathi Azar
Comments
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