Determining the Effectiveness of Cognitive Therapy Group on Fear of Negative Evaluation, Cognitive Flexibility and State-Trait Anxiety of Anxious Adolescents
Design
Non-randomized clinical trial with control group, parallel group, no blinding, on 30 patients.
The intervention and comparison groups were studied in a period of time.
Settings and conduct
The venue was Ayatollah Hashemi Rafsanjani High School for Girls, Sari city, and the sample was selected in a non-random and purposeful manner, they were assigned to an experimental group of 15 people and a control group of 15 people, and all three tests were performed on the experimental and control groups. However, the experimental group underwent 12 sessions of cognitive group therapy, then the questionnaire was re-administered for both groups, after 45 days after the post-test, the tests were re-administered for the follow-up period.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.Obtaining a score of at least 43 in the Spielberger Trait-Trait Anxiety Questionnaire
2. Age between 13 and 16 years
Exclusion criteria:
1.Absence of more than two sessions in treatment
Intervention groups
The intervention group includes anxiety patients who receive cognitive therapy group.
The control group is the anxiety patients who do not receive the cognitive therapy group.
Main outcome variables
Effect on the level of fear of negative evaluation, cognitive flexibility, trait state anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230524058277N2
Registration date:2023-06-11, 1402/03/21
Registration timing:retrospective
Last update:2023-06-11, 1402/03/21
Update count:0
Registration date
2023-06-11, 1402/03/21
Registrant information
Name
Bahram Mirzaian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3325 9528
Email address
bahrammirzaian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-11, 1401/09/20
Expected recruitment end date
2022-12-18, 1401/09/27
Actual recruitment start date
2022-12-25, 1401/10/04
Actual recruitment end date
2023-03-12, 1401/12/21
Trial completion date
2023-04-25, 1402/02/05
Scientific title
The Effectiveness of Cognitive Group Therapy on Fear of Negative Evaluation, Cognitive Flexibility and State-Trait Anxiety of Anxious Adolescents
Public title
The Effectiveness of Cognitive Group Therapy on Anxious Adolescents
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining a score of at least 43 in the Spielberger State-Trait-Anxiety Questionnair
Age between 13 and 16 years
He has not taken any psychiatric medication during the last three months
Do not suffer from an incurable physical disease such as cancer, MS, Alzheimer's and the like.
Do not suffer from a serious psychiatric illness such as psychotic or the like
Be literate at least up to the fifth grade
Completion of the informed consent agreement regarding participation in the research project
Do not undergo treatment or other psychological interventions during the research
Exclusion criteria:
Absence of more than two sessions in treatment
It should be determined that he has taken psychoactive drugs or drugs during the last 5 months
Suffering from mania or a psychotic disorder
The lack of inclusion criteria led to the exclusion of the research
Age
From 13 years old to 16 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committee of Islamic Azad University, Sari Branch
Street address
km 7 Darya road, Sari, Mazandaran province
City
Sari
Province
Mazandaran
Postal code
48164194
Approval date
2023-02-15, 1401/11/26
Ethics committee reference number
IR.IAU.SARI.REC.1401.232
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score in Spielberger Trait State Anxiety Questionnaire
Timepoint
At the beginning of the study (before the start of the intervention), the end of the intervention and 45 days after the end of the intervention.
Method of measurement
Spielberger Trait State Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The first session of the pre-test, welcoming and getting to know the group members with each other, the relevant rules and regulations, thinking and feeling training, providing homework in the field of concern formulation; The second session review and review the homework of the previous session, teaching negative spontaneous thoughts, practicing negative spontaneous thoughts related to group therapy, guided visual relaxation exercise, presenting homework in the field of compiling spontaneous thoughts in the A-B-C chain; The third session review and check the homework of the previous session, teaching the behavioral consequences of beliefs, practicing thought induction, teaching the downward arrow technique, practicing the downward arrow, presenting homework in the field of developing thought induction and analyzing the downward arrow by chain A- B-C; The fourth session is review and review of the homework of the previous session, continuation of the downward arrow technique, belief classification training, practice of belief classification, providing homework in the field of compilation of belief classification and downward arrow; The fifth session review and review the homework of the previous session, preparing the main list of beliefs and concerns, practicing the main list of beliefs and concerns, teaching cognitive map, preparing cognitive map, using the rating scale of mental discomfort, presenting homework in the field of classification classifying beliefs and practicing cognitive mapping; The sixth session review and check the homework of the previous session, teaching the list of beliefs and concerns, teaching objective analysis, practicing objective analysis, providing homework in the field of compiling objective analysis of beliefs; The seventh session review and check the homework of the previous session, standard analysis training, standard analysis practice, efficiency analysis training, efficiency analysis practice, providing assignments in the field of standard and efficiency analysis compilation; The 8th session review and check the homework of the previous session, teach logical analysis, practice and implement logical analysis, continue logical analysis, present homework in the field of logical analysis; The ninth session review and check the homework of the previous session, building a hierarchy of beliefs, practice building a hierarchy of beliefs, teaching opposition, practicing opposition, providing homework in the field of compiling opposition to beliefs; 10th session, reviewing and checking the homework of the previous session, training on perception change, filling in perception change forms, presenting homework on the field of perception change formulation; The eleventh and twelfth sessions review and check the homework of the previous session, self-discipline-self-reward training, sustainable change, use of mental imagery, closing ceremonies, appointments for follow-up and evaluation after treatment, post-test execution
Category
Rehabilitation
2
Description
Control group: It has not received any intervention. In addition, if interested, the members of the control group could receive the intervention done for the experimental group in the same treatment sessions after the completion of the plan.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Hashemi Rafsanjani High School
Full name of responsible person
Zahra Mostashtrikh
Street address
Ayatollah Hashemi Rafsanjani High School, at the beginning of Qaran St
City
Sari
Province
Mazandaran
Postal code
4818648474
Phone
+98 11 3331 1160
Email
rfsnjanyhashmy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Abbaszadeh Mousavi
Street address
Khazar Square, km 7 of Darya Road (Farahabad), Islamic Azad University Complex, Sari branch
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
+98 11 3303 2891
Email
ravabet-omomi@iau-tnb.ac.ir
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 Khayati Ghasem Kheyli
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Artah city, AbuKhel street
City
Ghaemshahr
Province
Mazandaran
Postal code
4769381416
Phone
+98 11 4219 4535
Email
Fz.khayati2022@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Bahram Mirzaian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Khazar Square, km 7 of Darya Road (Farahabad), Islamic Azad University Complex, Sari branch
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
+98 11 3303 2891
Email
bahrammirzaian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Zahra Khayati Ghasem Kheyli
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Artah city, Abu Khel street
City
Ghaemshahr
Province
Mazandaran
Postal code
4769381416
Phone
+98 11 4219 4535
Email
Fz.khayati2022@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 result or the like, can be shared
When the data will become available and for how long
One month after the end of the study
To whom data/document is available
There is no limit
Under which criteria data/document could be used
There is no limit
From where data/document is obtainable
Fz.khayati2022@gmail.com
To receive the documents, send your request to the email provided
What processes are involved for a request to access data/document
After sending the request to obtain the documents to the e-mail address, the documents will be sent after 10 working days