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The Effects of Neurofeedback on Attention Deficit Hyperactivity Disorder Symptoms, Time Perception and Mindfulness in Adults

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History
# Registration date Revision Id
3 2026-07-17, 1405/04/26 388038
2 2024-11-20, 1403/08/30 321340
1 2022-08-17, 1401/05/26 236804
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  • Protocol summary

    we aim to investigate the effects of EEG theta (4-8 Hz) and beta (13-30 Hz) ratio (TBR) neurofeedback training on time perception and mindfulness in adult patients with attention deficit disorder (ADD).
    we aim to investigate the effects of EEG theta (4-8 Hz) and beta (13-30 Hz) ratio (TBR) neurofeedback training on symptoms of attention deficit/hyperactivity disorder, time perception and mindfulness in adult patients with attention deficit disorder (ADD).
    هدف ما بررسی اثرات آموزش نوروفیدبک EEG تتا (4-8 هرتز) و نسبت بتا (13-30 هرتز) (TBR) بر درک زمان و ذهن آگاهی در بیماران بزرگسال مبتلا به اختلال نقص توجه (ADD) است.
    هدف ما بررسی اثرات آموزش نوروفیدبک EEG تتا (4-8 هرتز) و نسبت بتا (13-30 هرتز) (TBR) بر علائم اختلال نقص توجه / بیش فعالی، درک زمان و ذهن آگاهی در بیماران بزرگسال مبتلا به اختلال نقص توجه (ADD) است.
    Clinical trial with control group, with parallel groups, not blinded, randomized, phase 2 on 30 patients. A table of random numbers was used for randomization.
    Clinical trial with control group, with parallel groups, blinded, randomized, phase 2 on 30 patients. A table of random numbers was used for randomization.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، کور نشده، تصادفی شده، فاز 2 بر روی 30 بیمار. برای تصادفی سازی ازجدول اعداد تصادفی استفاده شد.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، کور شده، تصادفی شده، فاز 2 بر روی 30 بیمار. برای تصادفی سازی ازجدول اعداد تصادفی استفاده شد.
    time perception and mindfulness
    symptoms of attention deficit/hyperactivity disorder, time perception and mindfulness
    ادراک زمان و ذهن آگاهی
    علائم اختلال نقص توجه / بیش فعالی، ادراک زمان و ذهن آگاهی

  • General information

    Not blinded
    Single blinded
    1
    1
    empty
    The variable of symptoms of attention deficit/hyperactivity disorder and how to evaluate it was added. Also added information about blinding.
    empty
    متغیرعلائم اختلال نقص توجه / بیش فعالی و نحوه ارزیابی آن اضافه شد. همچنین اطلاعات مربوط به کورسازی اضافه شد.
    The Effects of Neurofeedback on Time Perception and Mindfulness in Adults with Attention Deficit Disorder
    The Effects of Neurofeedback on Attention Deficit Hyperactivity Disorder Symptoms, Time Perception and Mindfulness in Adults with Attention Deficit Disorder
    بررسی اثربخشی آموزش نوروفیدبک مبتنی بر ضریب تتا / بتا بر ذهن آگاهی و ادراک زمان در بزرگسالان مبتلا به اختلال نقص توجه / بیش فعالی
    بررسی اثربخشی آموزش نوروفیدبک مبتنی بر ضریب تتا / بتا بر علائم اختلال نقص توجه / بیش فعالی، ذهن آگاهی و ادراک زمان در بزرگسالان مبتلا به اختلال نقص توجه / بیش فعالی
    The Effects of Neurofeedback on Time Perception and Mindfulness in Adults with Attention Deficit Disorder
    The Effects of Neurofeedback on Attention Deficit Hyperactivity Disorder Symptoms, Time Perception and Mindfulness in Adults
    بررسی اثربخشی آموزش نوروفیدبک مبتنی بر ضریب تتا / بتا بر ذهن آگاهی و ادراک زمان در بزرگسالان مبتلا به اختلال نقص توجه / بیش فعالی
    بررسی اثربخشی نوروفیدبک مبتنی بر ضریب تتا / بتا بر علائم اختلال نقص توجه / بیش فعالی، ذهن آگاهی و ادراک زمان در بزرگسالان
    Neither the therapist nor participants were blinded. However, data analysts and outcome assessors were blinded to the participants’ group assignments.
    نه درمانگر و نه شرکت کنندگان کور نشدند. با این حال، تحلیلگران داده و ارزیاب‌های نتیجه نسبت به تکالیف گروهی شرکت‌کنندگان کور بودند.

  • Primary outcomes

    #1
    empty
    Attention deficit hyperactivity disorder is one of the most common neurodevelopmental disorders during childhood and can continue through adolescence into adulthood.
    empty
    اختلال نقص توجه بیش فعالی، یکی از شایع ترین اختلالات عصبی رشدی در دوران کودکی است و می تواند از نوجوانی تا بزرگسالی ادامه یابد.
    empty
    One week before the intervention and one week after the last intervention session
    empty
    یک هفته قبل از آغاز مداخله و یک هفته پس از آخرین جلسه مداخله
    empty
    It is the score that a person obtains in Integrated Visual and Auditory Continuous Performance Test (IVA), the Canners Adult ADHD Rating Scales.
    empty
    امتیازی است که فرد در آزمون عملکرد پیوسته دیداری و شنیداری یکپارچه (IVA)، مقیاس رتبه‌بندی ADHD بزرگسالان Canners کسب می‌کند.

  • Recruitment centers

    #1
    Name of recruitment center - English: Persian Gulf University
    Name of recruitment center - Persian: دانشگاه خلیج فارس
    Full name of responsible person - English: Farzaneh Yazdani
    Full name of responsible person - Persian: فرزانه یزدانی
    Street address - English: Persian Gulf Street, Persian Gulf University
    Street address - Persian: خیابان خلیج فارس، دانشگاه خلیج فارس
    City - English: Boushehr
    City - Persian: بوشهر
    Province: Boushehr
    Country: Iran (Islamic Republic of)
    Postal code: ۷۵۱۶۹۱۳۸۱۷
    Phone: +98 77 3122 2078
    Fax:
    Email: farzanehyazdani7371@gmail.com
    Web page address:
    Name of recruitment center - English: Persian Gulf University
    Name of recruitment center - Persian: دانشگاه خلیج فارس
    Full name of responsible person - English: Farzaneh Yazdani
    Full name of responsible person - Persian: فرزانه یزدانی
    Street address - English: Persian Gulf University, Persian Gulf Street, Boushehr, Iran.
    Street address - Persian: خیابان خلیج فارس، دانشگاه خلیج فارس، بوشهر، ایران.
    City - English: Boushehr
    City - Persian: بوشهر
    Province: Boushehr
    Country: Iran (Islamic Republic of)
    Postal code: 7516913817
    Phone: +98 77 3122 2078
    Fax:
    Email: farzanehyazdani7371@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Persian Gulf University
    Name of organization / entity - Persian: دانشگاه خلیج فارس
    Full name of responsible person - English: Farzaneh Yazdani
    Full name of responsible person - Persian: فرزانه یزدانی
    Street address - English: Persian Gulf Street, Persian Gulf University
    Street address - Persian: خیابان خلیج فارس، دانشگاه خلیج فارس
    City - English: Boushehr
    City - Persian: بوشهر
    Province: Boushehr
    Country: Iran (Islamic Republic of)
    Postal code: 7561673314
    Phone: +98 77 3122 2078
    Fax:
    Email: farzanehyazdani7371@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Persian Gulf University
    Name of organization / entity - Persian: دانشگاه خلیج فارس
    Full name of responsible person - English: Ruhollah Fatehi
    Full name of responsible person - Persian: روح الله فاتحی
    Street address - English: Persian Gulf University, Persian Gulf Street
    Street address - Persian: خیابان خلیج فارس، دانشگاه خلیج فارس
    City - English: Boushehr
    City - Persian: بوشهر
    Province: Boushehr
    Country: Iran (Islamic Republic of)
    Postal code: 7561673314
    Phone: +98 77 3122 2078
    Fax:
    Email: fatehi@pgu.ac.ir
    Web page address:

Protocol summary

Study aim
we aim to investigate the effects of EEG theta (4-8 Hz) and beta (13-30 Hz) ratio (TBR) neurofeedback training on symptoms of attention deficit/hyperactivity disorder, time perception and mindfulness in adult patients with attention deficit disorder (ADD).
Design
Clinical trial with control group, with parallel groups, blinded, randomized, phase 2 on 30 patients. A table of random numbers was used for randomization.
Settings and conduct
Following randomization and assignment of individuals in the study groups, patients are treated approximately twice a week using neurofeedback training. This study is performed in the psychology department of Persian Gulf University
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of attention deficit disorder; submission of written consent for participation in the study; No epilepsy or neurological diseases such as brain tumor and MS. Exclusion criteria: Absence from more than three sessions, lack of interest in continuing the sessions and lack of full cooperation during the sessions.
Intervention groups
Experimental group: theta (4-8 Hz) and beta (13-30 Hz) ratio (TBR) neurofeedback training will perform in the experimental group with the monopolar protocol in 20 sessions of 45 min each across a 2 months’ period. Control group: The control group does not receive feedback.
Main outcome variables
symptoms of attention deficit/hyperactivity disorder, time perception and mindfulness

General information

Reason for update
The variable of symptoms of attention deficit/hyperactivity disorder and how to evaluate it was added. Also added information about blinding.
Acronym
IRCT registration information
IRCT registration number: IRCT20211210053345N1
Registration date: 2022-08-17, 1401/05/26
Registration timing: prospective

Last update: 2024-11-21, 1403/09/01
Update count: 2
Registration date
2022-08-17, 1401/05/26
Registrant information
Name
Farzaneh Yazdani
Name of organization / entity
Persian golf univercity of bushehr
Country
Iran (Islamic Republic of)
Phone
+98 77 3426 2229
Email address
farzanehyazdani7371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-05, 1401/06/14
Expected recruitment end date
2022-10-06, 1401/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Neurofeedback on Attention Deficit Hyperactivity Disorder Symptoms, Time Perception and Mindfulness in Adults
Public title
The Effects of Neurofeedback on Attention Deficit Hyperactivity Disorder Symptoms, Time Perception and Mindfulness in Adults with Attention Deficit Disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of attention deficit disorder Submission of written consent for participation in the study No epilepsy or neurological diseases such as brain tumors and MS
Exclusion criteria:
Absence from more than three sessions Lack of interest in continuing the sessions Lack of full cooperation during the sessions
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
All patients who give consent for participation and who fulfilling the inclusion criteria are randomized using a random number table. In the random number table, a special code was assigned to each patient, respectively. To randomly assign each patient to the groups, the researcher randomly selected individuals from a table point in a row or direction.
Blinding (investigator's opinion)
Single blinded
Blinding description
Neither the therapist nor participants were blinded. However, data analysts and outcome assessors were blinded to the participants’ group assignments.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Bushehr University of Medical Sciences
Street address
University of Medical Sciences and Health Services, Moallem St., in front of Friday prayer place, Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Approval date
2021-10-16, 1400/07/24
Ethics committee reference number
IR.BPUMS.REC.1400.129

Health conditions studied

1

Description of health condition studied
Attention Deficit Disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders

Primary outcomes

1

Description
Time perception is actually an adaptive function that provides the ability to predict and react appropriately to future events. Perception of time is the mental experience of time and is often measured by understanding the time elapsed since a past event. In addition, due to the need to conceptualize the time period of events in preparing for and planning for subsequent actions (e.g., decision making), the perception of time is crucial for survival.
Timepoint
One week before the intervention and one week after the last intervention session
Method of measurement
It is a score that a person obtains on the software scale of time perception.

2

Description
Mindfulness is a way of being, understanding and understanding personal feelings. Mindfulness can also be considered as a form of mental training that can improve neuropsychological disorders in attention deficit / hyperactivity disorder such as attention control and working memory.
Timepoint
One week before the intervention and one week after the last intervention session
Method of measurement
It is the score that a person obtains in the mindfulness questionnaire (FFMQ)

3

Description
Attention deficit hyperactivity disorder is one of the most common neurodevelopmental disorders during childhood and can continue through adolescence into adulthood.
Timepoint
One week before the intervention and one week after the last intervention session
Method of measurement
It is the score that a person obtains in Integrated Visual and Auditory Continuous Performance Test (IVA), the Canners Adult ADHD Rating Scales.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: theta and beta ratio neurofeedback will perform in the experimental group with the monopolar protocol in 20 sessions of 45 min each across a 2 months’ period
Category
Behavior

2

Description
Control group: The control group will not receive any treatment until the end of the study.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Persian Gulf University
Full name of responsible person
Farzaneh Yazdani
Street address
Persian Gulf University, Persian Gulf Street, Boushehr, Iran.
City
Boushehr
Province
Boushehr
Postal code
7516913817
Phone
+98 77 3122 2078
Email
farzanehyazdani7371@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Persian Gulf University
Full name of responsible person
Ruhollah Fatehi
Street address
Persian Gulf University, Persian Gulf Street
City
Boushehr
Province
Boushehr
Postal code
7561673314
Phone
+98 77 3122 2078
Email
fatehi@pgu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Persian Gulf University
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
Persian Gulf University
Full name of responsible person
Soran Rajabi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Persian Gulf University, Persian Gulf Street
City
Bushehr
Province
Boushehr
Postal code
7516913817
Phone
+98 77 3122 2078
Email
soranrajabi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Persian Gulf University
Full name of responsible person
Parisa Azimisefat
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Persian Gulf University, Persian Gulf Street
City
Bushehr
Province
Boushehr
Postal code
7561673314
Phone
+98 77 3122 2078
Email
parisa0730@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Persian Gulf University
Full name of responsible person
Farzaneh Yazdani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Persian Gulf University, Persian Gulf Street
City
Bushehr
Province
Boushehr
Postal code
6719967444
Phone
0098773122079
Email
parisa0730@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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
Data from participants' responses to time perception and mindfulness questionnaires in pre-test and post-test were analyzed using SPSS software, and the results, without mentioning the names of the participants, were shared as study results.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data of this study will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data of this study will be provided for use by researchers in review or comparative studies
From where data/document is obtainable
Farzaneh Yazdani Department of Psychology, Persian Gulf University, Bushehr, Iran. farzanehyazdani7371@gmail.com
What processes are involved for a request to access data/document
The applicant provides information about their application via email. Up to two weeks after the request, if accepted, documents or data files will be sent.
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