Determining the effectiveness of neurofeedback on rumination and cognitive avoidance in people with obsessive-compulsive disorder
Design
A controlled, parallel-group, single-blind, randomized, phase 2 trial of 30 patients. The rand function of Excel software was used for randomization
Settings and conduct
After obtaining the necessary permits and referring to Rahmon's counseling and psychological services center in Amol, the people who meet the entry criteria and are willing to participate in the research will be identified, then the Yale Brown Practical Obsession Questionnaire will be distributed among the people,30 people who scored at least 16 from Yale Brown's Practical Obsession Questionnaire (1986) were selected as a sample and will be randomly assigned to an experimental group and a control group,The neurofeedback system will be used for the intervention of the experimental group. The participants in this study will be studied individually and for about two months through the neurofeedback device in rahnemon clinic. This research uses the Iranian BIOLINE 12-channel device, which can be implemented with the help of a computer system and related software
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. The selected people will be willing and interested in participating in the study.
2. Have obtained a minimum score of 16 from Yale Brown Practical Obsession Questionnaire
3. Be able to share their information and experiences.
Exclusion Criteria:
1. Having a history of physical disorder that involves mental struggle
Intervention groups
15 people will be assigned to the experimental group (related to neurofeedback exercises), 15 people will be assigned to the experimental group (control)
Main outcome variables
Neurofeedback is the independent variable of the present study. The first dependent variable is rumination and the second dependent variable is cognitive avoidance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230526058295N1
Registration date:2023-09-02, 1402/06/11
Registration timing:prospective
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Elahe Azizi
Name of organization / entity
Ayatollah amoli azade university
Country
Iran (Islamic Republic of)
Phone
+98 933 490 8016
Email address
e.azizi1998@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2023-09-16, 1402/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of neurofeedback on rumination and cognitive avoidance of people with obsessive-compulsive disorder
Public title
Investigating the effectiveness of neurofeedback on rumination and cognitive avoidance of people with obsessive-compulsive disorder
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The selected people are willing and interested in participating in the study
They Have obtained a minimum score of 16 from the 1986 Yale-Brown Obsession compulsion Questionnaire
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
People who met the entry criteria and were willing to participate in the research are identified. Then, Yale-Brown Practical Obsessive Compulsive Questionnaire was distributed among the people, 30 people who scored at least 16 from the Yale Brown Practical Obsessive Compulsive Questionnaire (1986) were selected as samples. 15 cards are prepared in the name of the experimental group and 15 cards in the name of the control group. After the cards are dealt, the participants will be asked to take one card each and place themselves in their group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
komite akhlagh Azad university of babol
Street address
3 km of Ghaemshahr road, Babol
City
Babol
Province
Mazandaran
Postal code
4615888774
Approval date
2023-07-03, 1402/04/12
Ethics committee reference number
IR.IAU.BABOL.REC.1402.016
Health conditions studied
1
Description of health condition studied
People with obsessive compulsive disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reducing post-test rumination and cognitive avoidance
Timepoint
Before the start of the intervention and two months after the start of the intervention
Method of measurement
Nolen, Hoeksma and Maro (1993) rumination questionnaire and Sexton and Dagas (2004) cognitive avoidance questionnaire in the pre-test and post-test stages.
Secondary outcomes
1
Description
Reducing the symptoms of obsessive-compulsive disorder
Timepoint
Two months after the start of the intervention
Method of measurement
Yale Brown Questionnaire (1986), Nolen, Hoeksma and Maro's Rumination Questionnaire (1993) and Sexton and Dagas Cognitive Avoidance Questionnaire (2004)
Intervention groups
1
Description
Intervention group: Intervention group: 15 people will be assigned to the experimental group (related to neurofeedback exercises), 15 people will be assigned to the control group. The experimental group receives neurofeedback training during 18 regular sessions over a period of 6 weeks and three sessions per week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rahnemon clinic
Full name of responsible person
Elahe azizi
Street address
Darya 27/1 Alley, taleb amoli Ave
City
Amol
Province
Mazandaran
Postal code
4615888774
Phone
+98 933 490 8016
Email
e.zizi1998@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rahnemon clinic
Full name of responsible person
Elahe azizi
Street address
Darya 27/1, Taleb amoli Ave
City
Amol
Province
Mazandaran
Postal code
4615888774
Phone
+98 933 490 8016
Email
e.azizi1998@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rahnemon clinic
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Rahnemon clinic
Full name of responsible person
Elahe azizi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Isar 5 Alley, Janbazan Ave
City
Amol
Province
Mazandaran
Postal code
4615888774
Phone
+98 933 490 8016
Email
e.azizi1998@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elahe azizi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Isar 5 Alley, Janbazan Ave
City
Amol
Province
Mazandaran
Postal code
4615888774
Phone
+98 933 490 8016
Email
e.azizi1998@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elahe Azizi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
isar 5 Alley, janbazab Ave
City
Amol
Province
Mazandaran
Postal code
4615888774
Phone
+98 933 490 8016
Email
e.azizi1998@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
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
All data is potentially shareable after de-identifying individuals.
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 will be available to all
Under which criteria data/document could be used
The use of documents for research and reference is allowed
From where data/document is obtainable
Applicants can apply through email to receive
Email: e.azizi1998@gmail.com
What processes are involved for a request to access data/document
Applicants can apply via email to receive within a few weeks