Design and evaluation of the effectiveness of interactive meta-diagnostic treatment software for social anxiety disorder.
Design
Purposeful and voluntary sampling, 6 people will be trained individually with interactive software for 10 treatment sessions.
Settings and conduct
Umm Al-Imam High School in Robat Karim will be the place of study. First, the diagnostic interview and the social phobia test complete, then Android App is installed each session will taught for 10 sessions. Each session will automatically test the software.
Participants/Inclusion and exclusion criteria
Six participants will be purposefully and judiciously will select from Umm Al-Imam School in Robat-Karim. Admission requirements: Must have social anxiety. Age between 15 and18. Exclusion criteria: no coexistence disorder with social anxiety
Intervention groups
Interactive software: This software designed in the Android environment with the Java programming language includes trans-diagnostic treatment methods for social anxiety disorder.
1. The software includes the test part of Connor Social Panic Questionnaire. Scores above 20, represent disorder.
2. Next, the diagnostic interview is based on the diagnostic and statistical guide of mental disorders 5th-edition.
3. Then we specify the goal setting table. What are the advantages and disadvantages of changing?
4. Then we try to get the precedents, answers and repetitive behaviors which repeat it when they get excited.
5. Teaching emotion and excitement. People with emotional disorders always want to suppress their emotions by avoiding.
6. Next, emotional driven behaviors will determine for the person identifies and corrects the behaviors that occur subconsciously with anxiety.
7. Practice mindfulness and being here and now is given to the authorities.
8. Practicing judgment and non-judgment is the last stage of treatment.
Main outcome variables
Social Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220406054427N3
Registration date:2022-06-25, 1401/04/04
Registration timing:registered_while_recruiting
Last update:2022-06-25, 1401/04/04
Update count:0
Registration date
2022-06-25, 1401/04/04
Registrant information
Name
Ghazal Zandkarimi
Name of organization / entity
Alzahra University
Country
Iran (Islamic Republic of)
Phone
+98 21 3507 4315
Email address
zandkarimi@refah.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and validation of the effectiveness of interactive meta-diagnostic treatment software for social anxiety disorder
Public title
Evaluation of the effectiveness of interactive meta-diagnostic software for social anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having social anxiety disorder
No other comorbid mental disorder due to clinical specialist approval
No use of arbitrator and other intervention at the same time as the course of treatment in this study
Exclusion criteria:
No other comorbid mental disorders
Age
From 15 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
6
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Al-Zahra University
Street address
Alzahra University, Deh Vanak St.
City
Tehran
Province
Tehran
Postal code
1371158545
Approval date
2022-04-06, 1401/01/17
Ethics committee reference number
IR.ALZAHRA.REC.1401.003
Health conditions studied
1
Description of health condition studied
Social Anxiety Disorder
ICD-10 code
F40.1
ICD-10 code description
Social phobias
Primary outcomes
1
Description
Social Anxiety Disorder
Timepoint
Measurements will be performed twice at the beginning of the study, then each time after each treatment session, for a total of 8 measurements, and then after one month of follow-up re-measurements.
Method of measurement
Social Panic Questionnaire (Connor, 2000)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The aim of this study was to design and evaluate the validity of effective interactive meta-diagnostic treatment software for social anxiety disorder. Sampling of the intervention group was purposeful and voluntary. In this study, 6 people will be individually trained with interactive software made of 8 sessions of treatment. Participants from the Umm al-Imam School in Robat Karim must be suffering from social anxiety. Age between 15 and 18 years, absence of comorbidity disorder and medication and other intervention during the study were the criteria for admission and not participating in more than two sessions of treatment and use of medication or other treatment during the study were among the exclusion criteria. Interactive software: This software designed in Android environment with Java programming language includes meta-diagnostic treatment methods for social anxiety disorder 1. The software includes the test section of Connor Social Panic Questionnaire, if a person gets a score above 20, he has a disorder. 2. The next step is the diagnostic interview based on DSM-5 criteria. If a person has a disorder syndrome, the system will give him feedback.3. Then we specify the goal setting table for the references. What are the advantages and disadvantages of changing or not? 4. In the next step: we try to gain an understanding of the emotions and behavioral behaviors of the clients. Understanding emotions and behaviors means understanding a person's antecedents, responses, and repetitive behaviors, which he or she repeats when he or she becomes emotional. 5. Teaching emotion and excitement. People with emotional disorders always want to suppress their emotions by avoiding it. In the next step, based on the perception of emotions and behaviors of the individual, we determine the behaviors caused by emotion. Our goal is to identify behaviors that evoke emotion, to identify and correct behaviors that occur subconsciously when experiencing anxiety. 7. Practice mindfulness and being in the here and now at this stage is given to the authorities. Practicing judgment and non-judgment is the last step in treatment. At this stage, the patient learns to distinguish between his judgment and non-judgment phases and realizes that he is the one who creates negative emotions for himself by judging.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Omalaemmeh High School
Full name of responsible person
Mrs Gholozadeh Correspondent Manager
Street address
Imam Khomeini Street, Nasirshahr, Robat Karim
City
Tehran
Province
Tehran
Postal code
1381158545
Phone
+98 21 4459 4906
Email
Taskhiri@gmail.com
Web page address
https://gama.ir/school/detail/8354/20ام%20الائمه
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Refah University College
Full name of responsible person
Dr. Ghazal Zandkarimi
Street address
Gol Mohammadi Street, beginning of People's Street, Baharestan
City
Tehran
Province
Tehran
Postal code
11575138
Phone
+98 21 3507 4315
Email
zandkarimi@refah.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Refah University College
Proportion provided by this source
100
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Refah University College
Full name of responsible person
Mahdeh Sadat Hashemi Mofrad
Position
MA University Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Gol Mohammadi Street, beginning of People's Street, Baharestan,
City
Tehran
Province
Tehran
Postal code
11575138
Phone
+98 21 3507 4338
Email
ms.hashemimofrad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Refah University College
Full name of responsible person
Dr. Ghazal Zandkarimi
Position
Faculty member of Psychology Group
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Gol Mohammadi Street, beginning of People's Street, Baharestan
City
Tehran
Province
Tehran
Postal code
11575138
Phone
+98 21 3507 4315
Email
ghazalzandi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Refah University College
Full name of responsible person
Dr. Zahra Askarikejad
Position
Faculty Member of IT Group
Latest degree
Ph.D.
Other areas of specialty/work
Health Technology Assessment
Street address
Gol Mohammadi Street, beginning of People's Street, Baharestan
City
Tehran
Province
Tehran
Postal code
11575138
Phone
+98 21 3507 4284
Email
asgharinejad@refah.ac.ir
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
Undecided - It is not yet known if there will be 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
Interactive software will be provided to treatment clinics for use after completion and usability. The results and data of this study will be presented to clinical professionals and students in this field after correspondence and fact-checking.
When the data will become available and for how long
Up to one year after the publication of the article
To whom data/document is available
Clinical professionals and psychology students
Under which criteria data/document could be used
To study anxiety disorders and integrated protocol treatment
From where data/document is obtainable
Ms. Hashemi Mofrad to email: ms.hashemimofrad@gmail.com
What processes are involved for a request to access data/document
The applicant submits an email to the submitted email and provides his / her full details. The applicant must be a clinical specialist or a psychology student. The name of the university must be clear. After confirming the information, the applicant would send the information to him.