The effectiveness of cognitive behavioral therapy in fear of negative evaluation, self-criticism, and self-focused attention in adolescents with social anxiety symptom
A review of the effectiveness of cognitive-behavioral therapy on the fear of negative evaluation, self-focused attention and self-criticism in adolescents with social anxiety syndrome.
Design
A clinical trial with a control group was conducted in a non-random and available manner on 30 patients who were randomly assigned to two groups, an experimental group of 15 people and a control group of 15 people.
Settings and conduct
After approving the proposal and obtaining the code of ethics and permission from the 2nd district education and school principals and by attending several girls' high schools, Lajarka questionnaire was taken from the students to confirm the diagnosis, and those who obtained high grades were given a clinical interview. It was done and the number of 30 people
It was selected non-randomly and those people were randomly assigned in two groups of 15 people, control and experimental.
Participants/Inclusion and exclusion criteria
Inclusion criteria
: age between 13 and 15
Completion of the informed consent form by the parents and the teenager to participate in the research project
have symptoms of social anxiety (based on the Lajerka questionnaire and structured clinical interview by a psychiatrist)
exclusion criteria:
Absence of more than one treatment session
Failure to do homework in more than one time
Intervention groups
After completing the questionnaires, the experimental group received cognitive behavioral therapy in eight sessions. Then they completed the questionnaires again. The control group also completed the questionnaires but did not receive treatment, then they completed the questionnaire again after two months
Main outcome variables
With the treatment, the mental condition and social communication of the students improved and the anxiety in social situations decreased, which increased the quality of life of the students.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240616062146N1
Registration date:2024-08-03, 1403/05/13
Registration timing:retrospective
Last update:2024-08-03, 1403/05/13
Update count:0
Registration date
2024-08-03, 1403/05/13
Registrant information
Name
fatemeh zahra sedaghat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3339 0832
Email address
sedaghatfatem9@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-13, 1402/11/24
Expected recruitment end date
2024-02-23, 1402/12/04
Actual recruitment start date
2024-01-21, 1402/11/01
Actual recruitment end date
2024-02-03, 1402/11/14
Trial completion date
2024-06-01, 1403/03/12
Scientific title
The effectiveness of cognitive behavioral therapy in fear of negative evaluation, self-criticism, and self-focused attention in adolescents with social anxiety symptom
Public title
The effectiveness of cognitive behavioral therapy in adolescents with social anxiety symptom
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 13 and 15
completing the informed consent agreement regarding participation in the research project
not having a substance use disorder
have social anxiety symptoms (based on the Lajerka adolescent anxiety questionnaire and structured clinical interview based on DSM 5 criteria by a psychiatrist
Not suffering from psychiatric disorders based on a structured clinical interview based on DSM 5 criteria by a psychiatrist.
Not suffering from vision and hearing problems so that the person cannot participate in the treatment process and complete the questionnaires.
Absence of acute and chronic physical diseases.
Exclusion criteria:
Absence of more than one treatment session
- Failure to do homework in more than one session
Unwillingness to continue participating in the treatment process for any reason.
Age
From 13 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Available selection and random assignment by lottery method in two blocks of experimental group and 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 Islamic Azad University
Street address
No, 481567896. shamshirband20 Ave. Shamshirband Blvd , Sari town
City
Sari
Province
Mazandaran
Postal code
4815678596
Approval date
2023-09-09, 1402/06/18
Ethics committee reference number
187. 1402.IR.IAU.SARI.REC
Health conditions studied
1
Description of health condition studied
Social anxiety disorder
ICD-10 code
F40.1
ICD-10 code description
Social anxiety disorder
Primary outcomes
1
Description
fear of negative evaluation
Timepoint
Measuring the fear of negative evaluation at the beginning of the study (before the start of the intervention) and after the end of the cognitive behavioral therapy sessions
Method of measurement
Brief Fear of Negative Evaluation Scale Leary (1983)
2
Description
Self _focused attention
Timepoint
Measuring self-focused attention at the beginning of the study (before the start of the intervention) and after the end of the cognitive behavioral therapy sessions
Method of measurement
In the focus of attention questionnaire of Woody, Chambless and Glass (1997)
3
Description
self-criticism
Timepoint
Measuring self-criticism at the beginning of the study (before the start of the intervention) and after the end of the cognitive behavioral therapy sessions
Method of measurement
The Levels of Self-Criticism Scale (LOSC; Thompson & Zuroff, 2004)
Secondary outcomes
1
Description
Fear score of negative evaluation
Timepoint
The time periods of measuring the fear of negative evaluation at the beginning of the study and after the end of the intervention
Method of measurement
12-item short form questionnaire (FNES-B)
2
Description
Self-focused attention score
Timepoint
The time periods of measuring the amount of self-focused attention at the beginning of the study and after the end of the intervention
Method of measurement
A 10-question questionnaire is the focus of attention
3
Description
self-criticism
Timepoint
The time periods of measuring the amount of self-criticism at the beginning of the study and after the end of the intervention
Method of measurement
22-question questionnaire (LOSC)
Intervention groups
1
Description
Intervention group: The experimental group of 15 adolescent girls with symptoms of social anxiety disorder in Sari city was selected in a non-random and accessible manner based on the inclusion criteria. Before implementing the intervention, three questionnaires of fear of negative evaluation, self-focused attention and self-criticism were taken from them. Then they received eight 90-minute sessions of cognitive behavioral therapy based on the Heimberg and Becker protocol.
Category
Behavior
2
Description
Control group: The control group of 15 teenage girls with symptoms of social anxiety disorder in Sari city was selected in a non-random and accessible manner based on the inclusion criteria. At the beginning of the work, at the same time as the experimental group, three questionnaires of fear of negative evaluation, self-focused attention and self-criticism were taken from them, and this group did not receive any intervention. After the experimental group received the intervention, questionnaires were taken again from both the control group and the experimental group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbari School
Full name of responsible person
Fatemeh zahra sedaghat
Street address
No, 481567896. shamshirband20 Ave. Shamshirband Blvd , Sari town
City
Sari
Province
Mazandaran
Postal code
4815678596
Phone
+98 11 3339 0832
Email
sedaghatfatem9@gmail.com
2
Recruitment center
Name of recruitment center
Shahid Falahi School
Full name of responsible person
Fatemeh zahra sedaghat
Street address
No, 481567896. shamshirband20 Ave. Shamshirband Blvd , Sari town
City
Sari
Province
Mazandaran
Postal code
4815678596
Phone
+98 11 3339 0832
Email
sedaghatfatem9@gmail.com
3
Recruitment center
Name of recruitment center
School of Islamic Sciences and Education
Full name of responsible person
Fatemeh zahra sedaghat
Street address
No, 481567896. shamshirband20 Ave. Shamshirband Blvd , Sari town
City
Sari
Province
Mazandaran
Postal code
4815678596
Phone
+98 11 3339 0832
Email
sedaghatfatem9@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh zahra sedaghat
Street address
No, 481567896. shamshirband20 Ave. Shamshirband Blvd , Sari town
City
Sari
Province
Mazandaran
Postal code
4815678596
Phone
+98 11 3339 0832
Email
sedaghatfatem9@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic 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
Fatemeh zahra sedaghat
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No, 481567896. shamshirband20 Ave. Shamshirband Blvd , Sari town
City
Sari
Province
Mazandaran
Postal code
4815678596
Phone
+98 11 3339 0832
Email
sedaghatfatem9@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh zahra sedaghat
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No, 481567896. shamshirband20 Ave. Shamshirband Blvd , Sari town
City
Sari
Province
Mazandaran
Postal code
4815678596
Phone
+98 11 3339 0832
Email
sedaghatfatem9@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh zahra sedaghat
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No, 481567896. shamshirband20 Ave. Shamshirband Blvd , Sari town
City
Sari
Province
Mazandaran
Postal code
4815678596
Phone
+98 11 3339 0832
Email
sedaghatfatem9@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
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
Only a part of the data, such as the information related to the main outcome or the like, can be shared
When the data will become available and for how long
Access starts 6 months after results are published
To whom data/document is available
Researchers working in academic and scientific institutions can access the data
Under which criteria data/document could be used
We have not considered other conditions.
From where data/document is obtainable
Dr. Maede Bagheri
09113546226
Mbagheri66.mb@gmail.com
What processes are involved for a request to access data/document
The applicant can receive the documents by submitting the code of ethics and sending her request to the mentioned email.