Investigating the pattern of transdiagnostic related to emotion regulation of adolescents with high-risk behavior and effectiveness of integrated transdiagnostic therapy on reduction of their anxiety, depression, and emotional dysregulation
The aim is nvestigating the pattern of transdiagnostic related to emotion regulation of adolescents with high-risk behavior and the effectiveness of integrated transdiagnostic therapy on the reduction of their anxiety, depression, and emotional dysregulation
Design
This study is conducted in the form of a clinical trial with a control group, with parallel groups, double-blind, randomized on 60 patients. The randomization method is a simple randomization method using the table of random numbers.
Settings and conduct
Azadi Urban Comprehensive Center. Using the table of random numbers, patients are randomly divided into two groups: The experimental group and the control group. Even numbers are considered for the experimental group and odd numbers are for the control group. Random allocation is done by the researcher and the clinical caregiver and data analyzer are unaware of the allocation of patients.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Diagnosis of anxiety based on Diagnostic and Statistical Manual of Mental Disorders (DSM); No use of Vitamin D3 before the study; Lack of any psychotherapy during the last 2 months. Exclusion Criteria: seizure; Systolic blood pressure over 12
Drug allergy.
Intervention groups
Patients receive 1 30-minute transdiagnostic training session every week for 12 weeks.
Main outcome variables
Anxiety, Depression, Emotional dysregulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230128057255N1
Registration date:2023-06-27, 1402/04/06
Registration timing:prospective
Last update:2023-06-27, 1402/04/06
Update count:0
Registration date
2023-06-27, 1402/04/06
Registrant information
Name
meysam nikdanesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4468 3203
Email address
meysamnikdanesh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-03, 1402/05/12
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the pattern of transdiagnostic related to emotion regulation of adolescents with high-risk behavior and effectiveness of integrated transdiagnostic therapy on reduction of their anxiety, depression, and emotional dysregulation
Public title
effectiveness of integrated transdiagnostic therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of anxiety based on Diagnostic and Statistical Manual of Mental Disorders (DSM)
No use of Vitamin D3 before the study
Lack of any psychotherapy during last 2 months
Exclusion criteria:
seizure
Systolic blood pressure over 12
Drug allergy
Age
From 12 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
60
Participants assigned randomly
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization method. The unit of randomization is individual. Using the table of random numbers, patients are randomly divided into two groups: The experimental group and the control group. Even numbers are considered for the experimental group and odd numbers are for the control group. Random allocation is done by the researcher and the clinical caregiver and data analyzer are not aware of the allocation of patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Treatment allocation was concealed from the therapist and the data analyzer who specified patients by using random table, and opaque, and sealed envelopes. participants pick up envelopes inside the box randomly which are in an unspecified wrapper. They are aware of which experimental group they were assigned to.
Placebo
Not used
Assignment
Parallel
Other design features
None
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences
Street address
Office of Vice President for International Affairs, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
14496-14535
Approval date
2022-01-26, 1400/11/06
Ethics committee reference number
IR.IUMS.REC.1400.999
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
3
Description of health condition studied
Emotional dysregulation
ICD-10 code
F93
ICD-10 code description
Emotional disorders with onset specific to childhood
Primary outcomes
1
Description
Anxiety symptoms
Timepoint
Assessment of anxiety at the beginning of the study (before the intervention), weeks 4, 8 and 12
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients do not receive any intervention during the 12 weeks.
Category
Behavior
2
Description
Intervention group: Patients receive 1 30-minute tranactional training session every week for 12 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Azadi Urban Comprehensive center
Full name of responsible person
Dr gholam hossein Alishiri
Street address
No 87, Azadi street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1343222305
Phone
+98 21 4456 7667
Email
Meysamnikdanesh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Mousavi Zadeh
Street address
No 8, Iran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4837
Fax
+98 21 8854 6783
Email
mousavizadeh.kiums@ac.ir
Web page address
https://iums.ac.ir/
Grant name
none
Grant code / Reference number
none
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Meysam Nikdanesh
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 65, Block 3, Ekbatan, Tehran
City
Tehran
Province
Tehran
Postal code
1446789545
Phone
+98 919 484 9599
Email
meysamnikdanesh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Meysam Nikdanesh
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 65, Block 3, Ekbatan, Tehran
City
Tehran
Province
Tehran
Postal code
1446789768
Phone
+98 919 484 9599
Email
meysamnikdanesh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Meysam Nikdanesh
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No 65, Block 3, Ekbata, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1447645678
Phone
+98 919 484 9599
Email
meysmnikdanesh@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 part of the data, such as information related to main outcome or like that , can be share.
When the data will become available and for how long
Start of access, 6 months after publishing the results
To whom data/document is available
Only people working in academic institutions could apply.
Under which criteria data/document could be used
People who are conducting clinical trials in this field could apply.
From where data/document is obtainable
By referring to the electronic address: s.hasanvandi@alzahra.ac.ir
What processes are involved for a request to access data/document
The applicant can receive information by registering the exact personal details.