1- Explaining the effectiveness of emotion regulation training on the social competence of students with social anxiety disorder
2- Explaining the effectiveness of emotion regulation training on interpersonal sensitivity of students with social anxiety disorder
Design
The clinical trial with a control group, randomized, on 40 patients who will be placed in two parallel intervention and control groups using the random block method and sealed envelopes.
Settings and conduct
This study will be conducted in the Bakhtiari-far high school in Semnan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: adolescents aged between 12 to 18 years, suffering from social anxiety disorder (with a score above 60 in the questionnaire), not receiving treatment interventions for social anxiety disorder.
Exclusion criteria: Having any other mental illness or disorder except social anxiety.
Intervention groups
The experimental group will receive 8 emotion regulation training sessions and the control group will not receive any intervention.
Main outcome variables
Social competency, Interpersonal sensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231102059929N1
Registration date:2023-11-08, 1402/08/17
Registration timing:registered_while_recruiting
Last update:2023-11-08, 1402/08/17
Update count:0
Registration date
2023-11-08, 1402/08/17
Registrant information
Name
ّFatemeh Babamohamadi
Name of organization / entity
Semnan university
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 2434
Email address
babamohamadifatemeh9@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-05, 1402/08/14
Expected recruitment end date
2024-02-09, 1402/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of emotion regulation training on interpersonal sensitivity and social competency of students with social anxiety disorder
Public title
The effectiveness of emotion regulation training on interpersonal sensitivity and social competency of students with social anxiety disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents in the age group of 12 to 18 years
Suffering from social anxiety disorder (with a score above 60 in Leibovitz's social anxiety questionnaire)
Not receiving any treatment plan for social anxiety disorder
Exclusion criteria:
Having a mental illness or disorder other than social anxiety
Age
From 12 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of samples to two groups (intervention or control) will be done randomly using the random blocks method (using the site https://www.sealedenvelope.com/simple-randomiser/v1/lists). 20 blocks with 2 cases in each are created and every time randomly a block will be selected. In this method, A: represents the intervention group; & B: the control group.
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 Semnan University of Medical Sciences
Street address
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2023-10-30, 1402/08/08
Ethics committee reference number
IR.SEMUMS.REC.1402.149
Health conditions studied
1
Description of health condition studied
Social anxiety disorder
ICD-10 code
F93.2
ICD-10 code description
Social anxiety disorder of childhood
Primary outcomes
1
Description
Interpersonal sensitivity means unnecessary and excessive vigilance towards the behavior and feelings of others.
Timepoint
Before the implementation of the intervention sessions, immediately after the intervention sessions and 1 month after the implementation
Method of measurement
Boyce and Parker interpersonal sensitivity questionnaire
2
Description
Social competence means a set of skills, the acquisition of which will improve people's social awareness.
Timepoint
Before the implementation of the intervention sessions, immediately after the intervention sessions and 1 month after the implementation
Method of measurement
Felner Social Competency Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, they receive 8 sessions with a duration of 90 minutes related to emotion regulation training using the Gross model method. In educational sessions, students are discussed about things such as the importance of emotions and their recognition methods, types of emotions, recognition of situations that cause emotions, examination of cognitive errors, methods of stopping thoughts, and methods of controlling emotions. The meetings will be held twice a week for one month.
Category
Behavior
2
Description
Control group: They will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bakhtiari Far High School
Full name of responsible person
Fatemeh Babamohamadi
Street address
Bakhtiarifar High School, Sane 11, Sane Street, Amir al-Momenin (AS) Square, Semnan
City
Semnan
Province
Semnan
Postal code
3519818494
Phone
+98 23 3349 1780
Email
babamohamadi99@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University
Full name of responsible person
Mohammad Hossein Ehsani
Street address
The central organization of Semnan University, first floor, western section, campus number one, in front of Sukan Park, Semnan
City
Semnan
Province
Semnan
Postal code
3513119111
Phone
+98 23 3153 5859
Fax
+98 23 3153 9840
Email
Research.VC@semnan.ac.ir
Web page address
https://research.semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University
Full name of responsible person
Parviz Sabahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mahdishahr Faculty of Psychology and Educational Sciences, Semnan University, Darband, Mahdishahr, Semnan
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3153 3030
Fax
+98 23 3153 3008
Email
p_sabahi@semnan.ac.ir
Web page address
https://psy.semnan.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Parviz Sabahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mahdishahr Faculty of Psychology and Educational Sciences, Semnan University, Darband, Mahdishahr, Semnan
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3153 3030
Fax
+98 23 3153 3008
Email
p_sabahi@semnan.ac.ir
Web page address
https://psy.semnan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Parviz Sabahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mahdishahr Faculty of Psychology and Educational Sciences, Semnan University, Darband, Mahdishahr, Semnan
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+98 23 3153 3030
Fax
+98 23 3153 3008
Email
p_sabahi@semnan.ac.ir
Web page address
https://psy.semnan.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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