The effectiveness of neurofeedback on working memory, cognitive flexibility and symptom severity in patients with mild depression
Design
The clinical trial has an intervention and control group.
The statistical population:80 people. On 30patients. Available and randomly (15 people in the experimental group and 15 people in the control group). All complete the questionnaire,only the intervention group is treated with neurofeedback.
Settings and conduct
Research Method: Semi-experimental and pre-test-post-test research design with control group.
The statistical population:patients with mild depression in the age range of 20 to 40years who refer to the psychological clinic of Avae Salamat in Rasht during the first quarter of 1400.depressed patient during 3months,twice a week and in Each session is followed by neurotherapy for 30 minutes.patients complete the questionnaire and only the intervention group receives neurofeedback treatment
Participants/Inclusion and exclusion criteria
Entry requirements:A diagnostic interview was conducted with a 20 to 40year No entry conditions:old person who referred to Avae Salamat Clinic;
If under other medical conditions or with a disorder other than mild depression
Intervention groups
Intervention group: Patients with mild depression under treatment. 15people in the experimental group and 15people in the control group.neurofeedback device and tools such as Beck Depression Inventory, Cognitive Flexibility Questionnaire and Active Memory Questionnaire will be used.patienrs complete the questionnaire,only the intervention group under Neurofeedback treatments are included.Neurofeedback therapy is a self-regulatory skill to make the brain more efficient. Ultimately, post-tests are taken from both groups.
Main outcome variables
Neurofeedback, Working Memory, Cognitive Flexibility, Severity of Patients' Symptoms with Mild Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210611051540N1
Registration date:2021-07-10, 1400/04/19
Registration timing:prospective
Last update:2021-07-10, 1400/04/19
Update count:0
Registration date
2021-07-10, 1400/04/19
Registrant information
Name
Maryam samadi tahergoorabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3334 2933
Email address
maryam.samadi995@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-14, 1400/04/23
Expected recruitment end date
2021-08-19, 1400/05/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Neurofeedback on Working Memory, Cognitive Flexibility and Severity of Patients' Symptoms with Mild Depression
Public title
Effect of Neurofeedback for the treatment of Depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the person is between 20 to 40 years
A diagnostic interview has been conducted with the person
The person has referred to Avae Salamat Clinic as a patient
Exclusion criteria:
If under other medical conditions
If the patient has severe depressive disorder
If the patient has a disorder other than depression
Age
From 20 years old to 40 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
At first, patients are selected according to the inclusion criteria. And then according to the random sequence obtained through Random allocation software
In the same way, patients will be randomly divided into experimental and control groups.
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
Ethics Committee of Lahijan Branch of Azad University
Street address
Unit9, Mahan building, Amoozgr alley, Hafez street
City
Rasht
Province
Guilan
Postal code
4144891459
Approval date
2021-06-07, 1400/03/17
Ethics committee reference number
IR.IAU.LIAU.REC.1400.017
Health conditions studied
1
Description of health condition studied
بیماران مبتلا به افسردگی خفیف
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Active Memory Score in the Active Memory Capacity Test by Daneman
Timepoint
Measurement of working memory at the beginning of the study and 10 sessions after starting neurotherapy
Method of measurement
Daneman Active Memory Capacity Test
2
Description
Cognitive flexibility score in Dena and Vanderwall cognitive questionnaire
Timepoint
Measurement of flexibility at the beginning of the study and 10 sessions after starting neurotherapy
Method of measurement
Cognitive Flexibility Questionnaire Dena and Vanderwall
3
Description
Depression score in Beck questionnaire
Timepoint
Measurement of the severity of depression at the beginning of the study and 10 sessions after starting neurotherapy
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with mild depression who receive neurofeedback treatment. The statistical population of this study will consist of all patients with mild depression who refer to Avaye Salamat psychological clinic during the first quarter of 1400. According to forecasts, the number of these people will be 80. A total of 30 patients will be selected by availability and randomly assigned to two groups (15 in the experimental group and 15 in the control group).In relation to therapeutic intervention and data collection, neurofeedback device treatment protocols and tools such as Beck Depression Inventory, Cognitive Flexibility Questionnaire and Active Memory Questionnaire will be used. Each depressed patient undergoes neurotherapy for 30 minutes 2 times a week for 3 months in each session. All patients complete the questionnaire and only the intervention group is treated with neurofeedback. The effectiveness of neurofeedback depends on the specific area of the brain depending on the type of disorder. In this form, the pattern of brain waves in the disorder is determined first, then the degree of deviation of the waves from the normal pattern is determined, which is done through quantitative electroencephalography.Quantitative electroencephalography is obtained from 19 cranial sites identified according to the 10-20 system, and in fact 19 electrodes are placed on the skull. In fact, we can say that neurofeedback technology response to psychotherapy, cognitive rehabilitation and poor cortical function It has been used successfully in the treatment of depression, anxiety, post-traumatic stress disorder, personality disorders, addiction, as well as obsessive-compulsive disorder. In this treatment, which is a self-regulatory skill, the brain works more efficiently with the awareness of the person with the disorder through auditory or graphic signals.Based on what has been said in this study, the question is whether neurofeedback has an effect on working memory, cognitive flexibility and the severity of symptoms of patients with mild depression referred to Ava Psychiatric Clinic in Rasht? Depression Inventory: This questionnaire was developed by Goldberg (1979) and has 18 items in a 5-point Likert scale; Very high (5), high (4), medium (3), low (2), very low (1) and not at all (0) are scored. The minimum and maximum scores of this questionnaire are 18 and 108, respectively, and its cut-off point is 54. Cognitive Flexibility Questionnaire: This questionnaire was developed by Dennis and Vanderwall (2010) and consists of 20 questions in a 7-point range; I strongly agree to strongly disagree. The questionnaire has three sub-components including; 1) the desire to understand difficult situations as controllable situations, 2) the ability to understand several alternative justifications for human life events and behavior, and 3) the ability to create multiple alternative solutions to difficult situations.This questionnaire has a minimum score of 20, a maximum score of 140 and a cut-off point of 80. Active Memory Questionnaire: This questionnaire was developed by Danman and Carpenter (1980) and consists of 27 sentences. These sentences are divided into six parts: two-sentence, three-sentence, four-sentence, five-sentence, six-sentence and seven-sentence.In which part of the test is the two-sentence section to the seven-sentence section read to the subjects, respectively, and they are asked to listen to these sections, each of which contains relatively difficult and unrelated sentences, and then two Do the following: 1- Recognize whether the sentence is semantically correct or not. 2. Write down the last word of each sentence. To score an active memory test, divide the number of correct answers in each section by the total number of sentences, and then add the number obtained from each section and divide it by two, the number obtained indicates the amount of memory capacity. Each subject will be active.
Category
Treatment - Devices
2
Description
Control group: Patients with mild depression who do not receive neurofeedback treatment. The statistical population of this study will consist of all patients with mild depression who refer to Avaye Salamat psychological clinic during the first quarter of 1400. According to forecasts, the number of these people will be 80. A total of 30 patients will be selected by availability and randomly assigned to two groups (15 in the experimental group and 15 in the control group).In relation to data collection, tools such as Beck Depression Inventory, Cognitive Flexibility Questionnaire and Active Memory Questionnaire will be used. All patients complete the questionnaire and only the intervention group will be treated with neurofeedback. The control group will complete the questionnaire twice.Once before the start of treatment in the experimental group and once after the end of treatment in the experimental group. Depression Inventory: This questionnaire was developed by Goldberg (1979) and has 18 items in a 5-point Likert scale; Very high (5), high (4), medium (3), low (2), very low (1) and not at all (0) are scored. The minimum and maximum scores of this questionnaire are 18 and 108, respectively, and its cut-off point is 54. Cognitive Flexibility Questionnaire: This questionnaire was developed by Dennis and Vanderwall (2010) and consists of 20 questions in a 7-point range; I strongly agree to strongly disagree. The questionnaire has three sub-components including; 1) the desire to understand difficult situations as controllable situations, 2) the ability to understand several alternative justifications for human life events and behavior, and 3) the ability to create multiple alternative solutions to difficult situations. This questionnaire has a minimum score of 20, a maximum score of 140 and a cut-off point of 80. Active Memory Questionnaire: This questionnaire was developed by Danman and Carpenter (1980) and consists of 27 sentences. These sentences are divided into six parts: two-sentence, three-sentence, four-sentence, five-sentence, six-sentence and seven-sentence. Each section of the test is read to the subjects in a two-sentence section to a seven-sentence section, respectively, and they are asked to listen to these sections, each of which contains relatively difficult and unrelated sentences, and then two Do the following: 1- Recognize whether the sentence is semantically correct or not. 2. Write down the last word of each sentence. To score an active memory test, divide the number of correct answers in each section by the total number of sentences, and then add the number obtained from each section and divide it by two, the number obtained indicates the amount of memory capacity. Each subject will be active.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Avae Salamat Counseling and Psychology Clinic
Full name of responsible person
Naghi Rahnama Nehzomi
Street address
Avae Salamat Counseling and Psychological Clinic,next to Dr. Zahrabi Laboratory, Enghelab St
City
Rasht
Province
Guilan
Postal code
4144794157
Phone
+98 13 3323 0993
Email
maryam.samadi995@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr.Gholamreza Vaghar Lahijani
Street address
unit9. Mahan building, Amoozegar alley, Hafez street
City
Rasht
Province
Guilan
Postal code
4144794159
Phone
+98 13 3334 2933
Email
maryam.samadi995@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Lahijan Branch of Azad University
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
Islamic Azad University
Full name of responsible person
Maryam Samadi Tahergoorabi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
unit9, Mahan building, Amoozegar alley, Hafez street
City
Rasht
Province
Guilan
Postal code
4144794157
Phone
+98 13 3334 2933
Email
maryam.samadi995@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Samadi Tahergoorabi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
unit9, Mahan building, Amoozegar Alley, Hafez street
City
Rasht
Province
Guilan
Postal code
4144794157
Phone
001333342933
Email
maryam.samadi995@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Samadi Tahergourabi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
unit9,Mahan building, Amoozgar alley, Hafez street
City
Rasht
Province
Guilan
Postal code
4144794157
Phone
+98 13 3334 2933
Email
maryam.samadi995@gmail.com
Web page address
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
Yes - There is 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 obtained from the results of questionnaires, diagnostic interviews and improving the performance of clients will be published.
When the data will become available and for how long
Access period starts from September 2021
To whom data/document is available
Data and other documents are available to all researchers in the field of research
Under which criteria data/document could be used
If other people request to receive data and documents, send a message to my personal email.
From where data/document is obtainable
Applicants should refer to Avae Salamat Clinic located in Rasht, Enghelab Street, next to Zohralabi Pharmacy, to receive the required documents or data.
Maryam Samadi Tahergorabi is responsible by calling 09380115195 and emailing maryam.samadi995@gmail.com.
What processes are involved for a request to access data/document
Applicants should call 09380115195 to receive the required documents or data or send an email to maryam.samadi995@gmail.com. Documents will be provided to them within 72 hours to a week.