Protocol summary

Study aim
Investigating the effectiveness of digital cognitive-behavioral therapy in reducing emotional disturbance and frustration in adolescent male students of Tehran's 6th district
Design
Type of study: semi-experimental, sample size of 30 people, two parallel groups of 15 people, one blind strain
Settings and conduct
Criteria for entering the research: gender, age, high score in tests Research location: Schools: Ayatollah Saeedi and Shahid Motahari
Participants/Inclusion and exclusion criteria
Research population: male adolescent students of district 6 of Tehran Sample size and calculation method: The research sample consists of 30 people who were selected by purposive sampling method and randomly replaced in two experimental and control groups. Sampling method: available Criteria for entering the research: gender, age, high score in tests
Intervention groups
For the members of the cognitive-behavioral therapy group, the proof is implemented digitally with the following specifications: the subjects go to the site https://azmonoravan.ir/ and enter the consultation section of the site using the username and password that was given to them earlier. be. There were 8 training sessions in the counseling section of the site (these 8 training sessions are in the form of video files. Each session contains training materials and exercises that the subject must look at and perform the exercises and report the results to the therapist from Submit through the site. There is a section for submitting exercises on the site.
Main outcome variables
Independent variables: digital cognitive-behavioral therapy Dependent variables: emotional disturbance, frustration, anxiety and depression level, academic performance Background variables: age, parents' education and family income Interfering variables: facilities related to access to digital therapy, non-compliance with digital therapy, lack of family support,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230704058669N1
Registration date: 2023-07-13, 1402/04/22
Registration timing: prospective

Last update: 2023-07-13, 1402/04/22
Update count: 0
Registration date
2023-07-13, 1402/04/22
Registrant information
Name
Mohsen Khani
Name of organization / entity
Semnan Azad University
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 3051
Email address
mohsenkhani615@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-15, 1402/04/24
Expected recruitment end date
2023-08-05, 1402/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of digital cognitive behavioral therapy on emotional disturbance, hopelessness in teenage male students
Public title
The effect of digital cognitive therapy on emotional disturbance
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
male teenager Obtaining high scores in the emotion disturbance questionnaire Ability to do homework online
Exclusion criteria:
Age
From 13 years old to 17 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, Semnan branch
Street address
1st floor, number 38, 10th street, North Kargar street, Tehran
City
Tehran
Province
Tehran
Postal code
1439683441
Approval date
2023-07-03, 1402/04/12
Ethics committee reference number
IR.IAU.SEMNAN.REC.1402.011

Health conditions studied

1

Description of health condition studied
Emotional Turmoil - Hopelessness
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
A score above 40 in the Simmons and Gaher Emotional Disturbance Questionnaire - Achieving a high score in the Beck Despair Questionnaire
Timepoint
Before starting the therapeutic intervention on the first day - after completing the therapeutic intervention on the 15th day
Method of measurement
Simmons and Gaher emotional disturbance questionnaire (2005) - Beck's Standardized Hopelessness Questionnaire (BHS)

Secondary outcomes

1

Description
Depression, stress, and anxiety scores in the DASS questionnaire and scores in the EPT academic achievement questionnaire
Timepoint
Before starting the therapeutic intervention on the first day - after completing the therapeutic intervention on the 15th day
Method of measurement
DASS Depression, Anxiety, Stress Questionnaire - Pham and TaylorEPT Educational Achievement Questionnaire

Intervention groups

1

Description
Intervention group: Subjects go to the site https://azmonoravan.ir/ and enter the consultation section of the site using the username and password that was given to them earlier. In the counseling section of the site, there are 8 educational sessions (cognitive behavioral therapy for emotional disturbance and despair) (these 8 educational sessions are in the form of video files. Each session includes educational materials and exercises that the subject must watch and the exercises Do it and send the results to the therapist through the site. The site has a section for sending exercises.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
بدون مرکز بیمارگیری
Full name of responsible person
---
Street address
----
City
Tehran
Province
Tehran
Postal code
1439683441
Phone
+98 21 8863 3051
Email
mohsenkhani615@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Karim Sohrabi
Street address
Semnan - km 5 of Damghan road - in front of Semnan customs
City
Semnan
Province
Semnan
Postal code
37111-35131
Phone
+98 23 3165 6565
Email
info@semnaniau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Khani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
First floor, No. 38, No. 38, 10th street, North Kargar St., Tehran
City
Tehran
Province
Tehran
Postal code
1439683441
Phone
+98 21 8863 3051
Email
mohsenkhani615@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Khani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
First floor, No. 38, No. 38, 10th street, North Kargar St., Tehran
City
Tehran
Province
Tehran
Postal code
1439683441
Phone
+98 21 8863 3051
Email
mohsenkhani615@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Khani
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
First floor, No. 38, No. 38, 10th street, North Kargar St., Tehran
City
tehran
Province
Tehran
Postal code
1439683441
Phone
+98 21 8863 3051
Email
mohsenkhani615@gmail.com

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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