Investigating The Effectiveness of Neurofeedback of the Slow Cortical Potentials (SCP) Training on Emotion Regulation, Cognitive Avoidance, and Perceived Anxiety in Adults with Generalized Anxiety Disorders
Investigate The effectiveness of Neurofeedback of the Slow Cortical Potentials (SCP) treatment on improvement of symptoms of people with generalized anxiety disorder
Design
In pre-test stage, each subject completes scales to measure generalized anxiety and its components.
Then subjects will be randomly divided into two treatment groups: SCP neurofeedback (experimental group) and control group (20 person in each group). The experimental group will enter the treatment phase and receive 12 treatment sessions with a specific anxiety protocol. In the post-test stage, the scales of the first stage are completed again by the people of both groups.
In order to respect human rights, the people of the control group will be informed that they are on the waiting list and their consent will be obtained. Also, they will be monitored weekly, and in case of critical situations, they will be guided to ensure that they still have the criteria to participate in the research.
Settings and conduct
The present research was conducted in Parand Clinic without blinding
Participants/Inclusion and exclusion criteria
Entry criteria:
age18_45 years.
have diagnosed generalized anxiety disorder with the tools used in the research.
Do not have a history of drug use.
Do not have a history of taking psychiatric drugs in the last six months.
Exit criteria:
Not completing questionnaires
Not completing the treatment
Taking psychiatric drugs
Intervention groups
The experimental group will receive 12 sessions of SCP neurofeedback therapy with a special protocol for anxiety. The control group will be supported by the researcher as long as they are on the waiting list.
Main outcome variables
Determining the effectiveness of SCP neurofeedback method on emotional regulation, cognitive avoidance and perceived anxiety intensity of people suffering from generalized anxiety disorder.
General information
Reason for update
Acronym
SCP
IRCT registration information
IRCT registration number:IRCT20240724062534N1
Registration date:2024-08-19, 1403/05/29
Registration timing:prospective
Last update:2024-08-19, 1403/05/29
Update count:0
Registration date
2024-08-19, 1403/05/29
Registrant information
Name
Nadia Entekhabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2613 4355
Email address
info@nadiabraincoach.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effectiveness of Neurofeedback of the Slow Cortical Potentials (SCP) Training on Emotion Regulation, Cognitive Avoidance, and Perceived Anxiety in Adults with Generalized Anxiety Disorders
Public title
Investigating The Effectiveness of SCP-Neurofeedback Training on Reducing Anxiety Symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have diagnosed generalized anxiety disorder with the tools used in the research.
Do not have a history of drug use.
Do not have a history of taking psychiatric drugs in the last six months.
Exclusion criteria:
Not completing any of the questionnaires.
Not completing the course of treatment.
Taking psychiatric drugs after starting treatment.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
The sample provided by each participant for this study includes the results of questionnaires that measure the intensity and type of anxiety symptoms. This sample is taken once at the beginning and once at the end of the intervention.
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects were randomly divided into two Neurofeedback of the Slow Cortical Potentials (SCP) treatment groups and the control group, and each group included 20 people. The randomization method is simple and the randomization unit is individual. A specific code is considered for each subject and using a table of random numbers, half of the codes enter the treatment group and the other half enter the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Generalized anxiety disorder: Generalized anxiety disorder is one of the most common anxiety disorders characterized by inexplicable, chronic and persistent worry.
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (after the last treatment session)
Method of measurement
Generalized anxiety disorder diagnostic evaluation interview along with the result of Spitzer's generalized anxiety disorder questionnaire.
2
Description
Emotional regulation: emotional regulation is a process by which people control and influence the occurrence and timing of experiences and expression of their emotions.
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (after the last treatment session)
Method of measurement
It is the score that a person will get in the questionnaire of difficulty in regulating the excitement of Gertz and Roemer.
3
Description
Cognitive avoidance: creating a coherent narrative about a personal experience requires specific information about this experience, but in the case of negative and traumatic experiences, due to the presence of strong negative emotions, recording this information is exhausting, and avoiding facing such negative emotions may prevent the construction of a The narrative is coherent.
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (after the last treatment session)
Method of measurement
Cognitive avoidance: It is a score measured by the Sexton and Dagas cognitive avoidance questionnaire.
4
Description
Cortical slow potential neurofeedback method: It is a therapeutic process that focuses on regulating the activation or inhibition of slow cortical waves.
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (after the last treatment session)
Method of measurement
Generalized anxiety disorder diagnostic evaluation interview along with the result of Spitzer's generalized anxiety disorder questionnaire.
5
Description
Perceived anxiety intensity
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (after the last treatment session)
Method of measurement
It is the score that a person will get in the depression anxiety tension questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People in the intervention group enter the intervention phase after the first stage of evaluation and receive twelve sessions of neurofeedback treatment with the slow cortical potential (SCP) method. Treatment sessions are performed three times a week and the entire treatment process lasts four weeks. The purpose of SCP neurofeedback treatment is to increase brain wave self-regulation skills, and this goal is achieved by teaching research participants to control brain wave patterns related to cognition and emotion (slow cortical potential or SPC). This training process is provided by providing instant feedback. In the SCP neurofeedback method, each session consists of three run, each run including at least thirty trial by the subject. Each trial lasts eight seconds and there is a thirty second rest between each run. In this way, the time of each treatment session will be thirty minutes. In each treatment session, two electrodes are used to measure the activity of the cerebral cortex. The positive electrode is placed on the forehead, above the arch of the eyebrow because this area is associated with emotional regulation and cognitive processes (point F4 in the 10-20 division system), and the reference electrode is placed on the ear. During the treatment session, half of the attempts ( fifteen numbers) related to the decrease of the negative slow cortical potential and the other half of the efforts related to the increase of the positive slow cortical potential. In this way, both the reduction of arousal and irritability and the increase of emotional resilience and cognitive control are targeted in order to achieve the best results for people with generalized anxiety disorder. It is worth mentioning that the treatment is performed with the Mind Media NEXUS 10 device.
Category
Treatment - Devices
2
Description
Control group: After the first stage evaluation, the control group enters the waiting list for four weeks. During these four weeks, people in this group were monitored through weekly phone calls to ensure that they did not take any medication, did not receive any other treatment, and did not experience a major change in their lives. Also, in case of critical situations, they are provided with brief recommendations to control anxiety. After four weeks, the people of this group entered the second stage of evaluation and after completing the research process, in order to preserve human rights, the treatment implemented for the intervention group will receive
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Paarand clinic
Full name of responsible person
DR. Masoud Nosratabadi
Street address
NO 117, 9th Boostan Ave., Pasdaran Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1978954735
Phone
+98 21 2613 4355
Email
nadiyaentekhabi9@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Paaran clinic
Full name of responsible person
DR. Masoud Nosratabadi
Street address
NO 117, 9th Boostan Ave., Pasdaran Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1978954735
Phone
+98 21 2613 4355
Email
nadiyaentekhabi9@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Paaran clinic
Proportion provided by this source
10
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nadia Entekhabi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Koodakyar End, Shahid Shahriari Square,
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
009822180083
Email
nadiyaentekhabi9@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
DR. Fereshteh Momeni
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Koodakyar End, Daneshjoo Blvd., Shahid Shahriari Square, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Fax
Email
momenipsy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences