Protocol summary
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Study aim
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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).
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Design
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Clinical trial with control group, with parallel groups, blinded, randomized, phase 2 on 30 patients. A table of random numbers was used for randomization.
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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symptoms of attention deficit/hyperactivity disorder, time perception and mindfulness
General information
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Reason for update
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The variable of symptoms of attention deficit/hyperactivity disorder and how to evaluate it was added. Also added information about blinding.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211210053345N1
Registration date:
2022-08-17, 1401/05/26
Registration timing:
prospective
Last update:
2026-07-25, 1405/05/03
Update count:
2
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Registration date
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2022-08-17, 1401/05/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-09-05, 1401/06/14
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Expected recruitment end date
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2022-10-06, 1401/07/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effects of Neurofeedback on Attention Deficit Hyperactivity Disorder Symptoms, Time Perception and Mindfulness in Adults
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Public title
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The Effects of Neurofeedback on Attention Deficit Hyperactivity Disorder Symptoms, Time Perception and Mindfulness in Adults with Attention Deficit Disorder
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 45 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Neither the therapist nor participants were blinded. However, data analysts and outcome assessors were blinded to the participants’ group assignments.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-10-16, 1400/07/24
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Ethics committee reference number
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IR.BPUMS.REC.1400.129
Health conditions studied
1
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Description of health condition studied
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Attention Deficit Disorder
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ICD-10 code
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F90
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ICD-10 code description
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Attention-deficit hyperactivity disorders
Primary outcomes
1
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Description
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Attention deficit hyperactivity disorder is one of the most common neurodevelopmental disorders during childhood and can continue through adolescence into adulthood.
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Timepoint
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One week before the intervention and one week after the last intervention session
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Method of measurement
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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
1
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Description
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Time perception
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Timepoint
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One week before the intervention and one week after the last intervention session
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Method of measurement
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It is a score that a person obtains on the software scale of time perception.
2
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Description
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Mindfulness
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Timepoint
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One week before the intervention and one week after the last intervention session
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Method of measurement
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It is the score that a person obtains in the mindfulness questionnaire (FFMQ)
Intervention groups
1
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Description
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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
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Category
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Behavior
2
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Description
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Control group: The control group will not receive any treatment until the end of the study.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Persian Gulf University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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The access period starts 6 months after the results are published
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To whom data/document is available
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The data of this study will be available only to researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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The data of this study will be provided for use by researchers in review or comparative studies
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From where data/document is obtainable
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Farzaneh Yazdani Department of Psychology, Persian Gulf University, Bushehr, Iran. farzanehyazdani7371@gmail.com
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What processes are involved for a request to access data/document
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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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Comments
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