Determining the effect of QEEG-based neurofeedback therapy on reducing symptoms and symptoms of people with generalized anxiety disorder and improving the emotional regulation strategies
Design
In this study, 30 patients with generalized anxiety disorder who were admitted to treatment were selected from student population of Zanjan city and divided into intervention and control groups.
Settings and conduct
After clinical interview (SCID-I) and confirmation of the criteria for entry and exit of patients, all of the subjects used a questionnaire for general anxiety disorder, an emotional regulation strategy questionnaire, a depression questionnaire, and anxiety and stress by a researcher at the educational center - Shahid Beheshti treatment will be implemented. Treatment protocols will be written and implemented in the QEEG based neurofeedback therapy group using data from brain wave patterns
Participants/Inclusion and exclusion criteria
Having DSM-5 diagnostic criteria for generalized anxiety disorder diagnosed by a psychiatrist based on diagnostic interview and clinical psychologist.Psychotic Disorder and Substance Abuse Based on Diagnostic Interview
Intervention groups
15 subjects will be treated on the basis of QEEG-based neurofeedback training, and 15 subjects will not receive any intervention in the control group, and individual treatment will be followed for subjects in the QEEG-based neurofeedback treatment group.
Main outcome variables
Decrease Signs and symptoms of people with generalized anxiety disorde؛Improves the emotional regulation of people with generalized anxiety disorder
General information
Reason for update
Acronym
NT
IRCT registration information
IRCT registration number:IRCT20171102037181N1
Registration date:2018-01-21, 1396/11/01
Registration timing:prospective
Last update:2018-01-21, 1396/11/01
Update count:0
Registration date
2018-01-21, 1396/11/01
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3286 7507
Email address
hassan.abdiyan89@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-31, 1396/11/11
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
2018-01-31, 1396/11/11
Actual recruitment end date
2018-06-21, 1397/03/31
Trial completion date
empty
Scientific title
Efficacy of QEEG Guided Neurofeedback treatment on decreasing symptoms and signs of Generalized Anxiety Disorder and emotion regulation strategies.
Public title
Efficacy of Neurofeedback treatment on Anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having DSM-5 diagnostic criteria for generalized anxiety disorder diagnosed by a psychiatrist based on diagnostic interview and clinical psychologist; as well as on the basis of the 7-item GAD-7 questionnaire and DSM-5 Clinical Interview for generalized Anxiety Disorder
At least 18 years and maximum 50 years
Study at one of the academic levels
Patient agrees to participate in research and sign a written consent
Exclusion criteria:
Suffering Psychotic disorder And Substance Abuse Based on Diagnostic Interview.
Not receiving psychological treatment at least 6 months before entering the research.
No drug use at least one month before entering the research.
Having complete criteria for personality disorder in axis II based on diagnostic interview.
The apparent risk of suicide is now.
Having more than two absentee sessions.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences Ethics Committee.
Street address
Central Station of Zanjan University of Medical Sciences-Beginning of the Islamic Republic Boulevard-Azadi Square.
City
zanjan
Province
Zanjan
Postal code
45154
Approval date
2017-09-11, 1396/06/20
Ethics committee reference number
ZUMS.REC.1396.138
Health conditions studied
1
Description of health condition studied
Generalized Anxiety Disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
The severity of the signs and symptoms of generalized anxiety disorder
Timepoint
The effect of neurofeedback treatment in patients with generalized anxiety disorder before, after and three months after treatment.
Method of measurement
The score that the subject gained from the GAD-7 questionnaire is the GAD-7. This scale has been developed to diagnose anxiety disorder and to measure the severity of clinical symptoms.
Secondary outcomes
1
Description
Emotional regulation.
Timepoint
Evaluating the improvement of emotional regulation strategies before, after and three month following the treatment of neurofeedback.
Method of measurement
The score for the subject of the Emotional Regulation Strategies Questionnaire (ERQ; Grass & John, 2003) was designed to evaluate two emotion regulation strategies, including suppression and re-evaluation. This questionnaire has 10 sentences.
2
Description
Anxiety
Timepoint
Evaluation before, after, and in the following three months.
Method of measurement
The score that the subject obtained from the Depression, Anxiety and Stress Questionnaire (DASS).
3
Description
Depending on the DSM-5 criteria, depression involves a number of disorders that all agree on three types of symptoms: mood symptoms that include: feeling sad, empty, worrying and irritable. Vegetative symptoms that include fatigue, social deprivation and diabetes. Disturbances in appetite (depression or increased sleep) are also common. The cognitive symptoms of these disorders include centralized problems, difficulty in resolving, low self confidence, negative thoughts about oneself, the world, and others, and guilty and suicidal ideation.
Timepoint
Evaluation before, after, and in the following three months.
Method of measurement
The score that the subject obtained from the Depression, Anxiety and Stress Questionnaire (DASS).
Intervention groups
1
Description
Intervention group: 15 subjects will be treated on the basis of QEEG-based neurofeedback training, and 15 subjects will not receive any intervention in the control group, and individual treatment will be followed for subjects in the QEEG-based neurofeedback treatment group.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized and specialized specialty clinic of Suhrawardi.
Full name of responsible person
Hasan Abdiyan Kalibar
Street address
Eastern Side of Shahid Beheshti Hospital.Ork Gate
City
Zanjan
Province
Zanjan
Postal code
56184- 45139
Phone
+98 24 3354 2401
Fax
+98 24 3354 2401
Email
h.abdiyan25@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shaghli
Street address
Central Station of Zanjan University of Medical Sciences-Beginning of the Islamic Republic Boulevard-Azadi Square.
City
zanjan
Province
Zanjan
Postal code
۴۵۱۵۴
Phone
Email
h.abdiyan25@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Hasan Abdiyan Kalibar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Eastern Side of Shahid Beheshti Hospital-Ork Gate
City
zanjan
Province
Zanjan
Postal code
56184- 45139
Phone
+98 24 3354 2401
Email
h.abdiyan25@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hasan Abdiyan Kalibar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Eastern Side of Shahid Beheshti Hospital-Ork Gate
City
zanjan
Province
Zanjan
Postal code
56184- 45139
Phone
+98 24 3354 2401
Email
h.abdiyan25@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hasan Abdiyan Kalibar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Eastern Side of Shahid Beheshti Hospital-Ork Gate
City
Zanjan
Province
Zanjan
Postal code
56184- 45139
Phone
+98 24 3354 2401
Email
h.abdiyan25@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
In the consent form, personal information will be confidential and the data will be published by the general and a group of members.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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