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The Effectiveness of Adding QEEG-Guided Neurofeedback to SSRIs in Patients with Obsessive-Compulsive Disorder (OCD)

Protocol summary

Study aim
The Effectiveness of Adding QEEG-Guided Neurofeedback to Selective serotonin reuptake inhibitors (SSRIs) in Patients with Obsessive-Compulsive Disorder (OCD)
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, on 60 patients. Randomaize.com was used for randomization.
Settings and conduct
conducted at Ibn Sina Hospital, Mashhad. In this study, 60 patients with OCD are divided into two groups.
Participants/Inclusion and exclusion criteria
1- Age between 18 and 40 years. 2- Diagnosis of OCD based on DSM-5 criteria by a psychiatrist. 3-Yale-Brown Obsessive-Compulsive Scale Y-BOCS test score > 16. 5- Absence of other Axis 1 disorders,schizophrenia, bipolar disorder, depression, etc., mental retardation, substance abuse or psychiatric disorders due to medical problems that require treatment (considering the high association of obsessive-compulsive disorder with depression mild and moderate depression is allowed to enter the plan) 6- Absence of other treatment or use of cognitive therapy.
Intervention groups
In this study, 60 patients with OCD are divided into two groups, intervention and control, and by the (Y-BOCS), Beck Depression Test and Beck Anxiety Test at the beginning and end of the study, the tests Cognitive CANTAB related to obsessive-compulsive disorder and QEEG are evaluated at the beginning and end of the study and every two weeks during the study. According to the psychiatrist's diagnosis, fluoxetine 40-60 mg or the equivalent of another SSRI approved for the treatment of OCD is prescribed for the two test groups, and the intervention group receives neurofeedback based on the brain map pattern three times a week for two months.
Main outcome variables
Examining the level of obsession before and after the intervention by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) test. changes of brain waves

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231021059781N1
Registration date: 2023-10-24, 1402/08/02
Registration timing: prospective

Last update: 2023-10-24, 1402/08/02
Update count: 0
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
mazyar fathi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
fathima@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Adding QEEG-Guided Neurofeedback to SSRIs in Patients with Obsessive-Compulsive Disorder (OCD)
Public title
The Effectiveness of QEEG-Guided Neurofeedback in Patients with (OCD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Age between 18 and 40 years.2- Diagnosis of OCD based on DSM-1V criteria by a psychiatrist.3- Y-BOCS test score > 16.4- Filling the informed consent form.5- Absence of other Axis 1 disorders, for example, schizophrenia, bipolar disorder, depression, etc., mental retardation, substance abuse or psychiatric disorders due to medical problems that require treatment (considering the high association of obsessive-compulsive disorder with depression mild and moderate depression is allowed to enter the plan)6- Absence of other treatment or use of cognitive therapy.
Exclusion criteria:
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. Blocks are small and balanced with predetermined group assignments, which keeps the numbers of subjects in each group similar at all times.[1,2] The block size is determined by the researcher and should be a multiple of the number of groups (i.e., with two treatment groups, block size of either 4, 6, or 8). Blocks are best used in smaller increments as researchers can more easily control balance.
Blinding (investigator's opinion)
Single blinded
Blinding description
Researchers who perform data analysis and data recording are kept blind to the data of the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کارگروه منطقه ای اخلاق در پژوهش‏های زیست پزشکی دانشگاه علوم پزشکی مشهد
Street address
Research Technology, Qurashi Building, next to Hoize Cinema, Mashhad, University St, Khorasan, Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-09-11, 1402/06/20
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.180

Health conditions studied

1

Description of health condition studied
A disorder characterized by the presence of persistent and recurrent irrational thoughts (obsessions), resulting in marked anxiety and repetitive excessive behaviors (compulsions) as a way to try to decrease that anxiety.
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder

Primary outcomes

1

Description
Examining the level of obsession before and after the intervention in order to evaluate the effectiveness of the intervention using the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), examining the changes in brain waves related to the disease before and after the intervention using the Neuroguide software and every two weeks thereafter From the beginning of the intervention. Checking the improvement of cognitive functions such as maintaining attention, visual memory, working memory, attention shift and response inhibition by CANTAB software before and after the intervention and every two weeks after the intervention. Checking the level of anxiety and depression in two stages: Before and after the end of the intervention by Beck's anxiety and depression questionnaires.
Timepoint
Illness before and after the intervention by and every two weeks after the start of the intervention
Method of measurement
(Y-BOCS)، NEUROGUID, CANTAB , BDI, BAI

2

Description
Yale Brown Obsessive-Compulsive Scale
Timepoint
the beginning and end of the study,
Method of measurement
Yale Brown Obsessive-Compulsive Scale (Y-BOCS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 30 patients with OCD who, in addition to SSRI drug treatment (fluoxetine 40-60 mg or its equivalent from another SSRI approved for OCD treatment), are treated with neurofeedback based on brain mapping.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
bn Sina Hospital, Mashhad
Full name of responsible person
mazyar fathi
Street address
Razavi Khorasan Province, Mashhad, Boulevard, 8HGM+6QV
City
mashhad
Province
Razavi Khorasan
Postal code
٩١٩۵٨٣١٣۴
Phone
+98 51 3711 2540
Fax
+98 51 3712 4184
Email
fathimazyar@yahoo.com
Web page address
https://pbsrc.mums.ac.ir/index.php

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.mohammad hossein Ebrahimzadeh
Street address
Khorasan, Razavi, Mashhad, University St., next to Hoize Cinema, Qurashi Building, Research and Technology.
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.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
Ali Talaei
Position
Professor of Psychiatry 1. Head of Psychiatric and Behavioral Sciences Research Center of Mashhad Un
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn-e Sina Psychiatric Hospital, Hor Al Ameli Blvd., Bu-Ali Sq., Ferdowsi Sq., Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
21 0051 37112540
Email
Talaeia@mums.ac.ir
Web page address
https://pbsrc.mums.ac.ir/members/director

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Talaei
Position
1. Head of Psychiatric and Behavioral Sciences Research Center of Mashhad University of Medical Scie
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibn-e Sina Psychiatric Hospital, Hor Al Ameli Blvd., Bu-Ali Sq., Ferdowsi Sq., Mashhad, Iran
City
masshad
Province
Razavi Khorasan
Postal code
٩١٩۵٨٣١٣۴
Phone
+98 51 3711 2540
Email
Talaeia@mums.ac.ir
Web page address
https://pbsrc.mums.ac.ir/members/director

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mazyar fathi
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Ibn-e Sina Psychiatric Hospital, Hor Al Ameli Blvd., Bu-Ali Sq., Ferdowsi Sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٩۵٨٣١٣۴
Phone
+98 51 3711 2540
Email
fathimazyar@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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data is published in a general and summarized form, and personal information will not be published separately.
When the data will become available and for how long
The access period starts from 1403 for one year
To whom data/document is available
Researchers who participate in this study and participate in the data analysis process can have access to the data.
Under which criteria data/document could be used
Conduct a similar study
From where data/document is obtainable
Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences
What processes are involved for a request to access data/document
Having the proposal justified and approved by the ethics committee
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