Effectiveness of transdiagnostic unified protocol on anxiety symptoms, emotion dysregulation and intolerance of uncertainty in youth with anxiety disorders
The aim of this study was to evaluate the effectiveness of an integrated transdiagnostic treatment protocol on the symptoms of anxiety, emotion dysregulation and intolerance in adolescents with mental disorders.
Design
This research has a control group and an experimental group; no blinding. This treatment was performed on 60 samples. People were placed randomly into two groups by throwing the coin method.
Settings and conduct
The statistical population in this study consists of all adolescents aged 15 to 17 years with anxiety disorders in Sanandaj. To select the sample using the target sampling method, 60 adolescents aged 15 to 17 years to patients with mental disorders studying in the academic year 1401-1400 in high schools in Sanandaj who have referred to school counseling centers and are willing to Collaborate. The characteristics of participating in the research will be selected and randomly assigned to the experimental and control groups.
Participants/Inclusion and exclusion criteria
Age 15 to 17 years; willingness to cooperation
Intervention groups
The integrated metadiagnostic treatment protocol includes 8 modules. This protocol is a type of cognitive-behavioral therapy focused on emotion, which is designed for people with emotional disorders, especially people with anxiety disorders. In order to comply with the ethical principles of the research, after the completion of the treatment period, the control group will also receive the mentioned intervention.
Main outcome variables
Anxiety symptoms, emotion dysregulation, and intolerance of ambiguity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220303054173N1
Registration date:2022-08-09, 1401/05/18
Registration timing:registered_while_recruiting
Last update:2022-08-09, 1401/05/18
Update count:0
Registration date
2022-08-09, 1401/05/18
Registrant information
Name
Saman Ezati
Name of organization / entity
The University of Kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 87 3562 3220
Email address
samanezatii1372@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-31, 1401/05/09
Expected recruitment end date
2022-08-31, 1401/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of transdiagnostic unified protocol on anxiety symptoms, emotion dysregulation and intolerance of uncertainty in youth with anxiety disorders
Public title
Effectiveness of transdiagnostic unified protocol on anxiety symptoms, emotion dysregulation and intolerance of uncertainty in youth with anxiety disorders
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 15 to 17
Evidence of diagnosis of comorbid anxiety disorders according to DSM-5 criteria based on psychiatrist or clinical psychologist diagnosis according to structured interview SCID-5
Do not take sedatives
Failure to receive other therapeutic interventions at the same time as the present study
Exclusion criteria:
A diagnosis other than anxiety disorders
Lack of parental consent
The teenager's lack of consent
Not being a student this year
Age
From 15 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, in order to randomize the coin toss method, which is usually used to create a random sequence in two-group trials, in such a way that one of the Rashir study groups and the other group are considered as lines and based on the desired sample size. We threw the same number of coins and randomly assigned people to two groups.
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
Research Ethics Commitees of university of kurdistan
Street address
Resalat St., Ahmad Fani Blvd., Nehzat Apartment, Block 7, No. 4
City
Sanandaj
Province
Kurdistan
Postal code
6617775864
Approval date
2022-01-07, 1400/10/17
Ethics committee reference number
IR.UOK.REC.1400.033
Health conditions studied
1
Description of health condition studied
Anxiety symptoms
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
anxiety symptoms
Timepoint
Pre-test-post-test -6 months follow-up
Method of measurement
(YAM)DSM-5,(ERQ-C),(IUSC-12),(PSWQ-C)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group underwent integrated meta-diagnostic treatment for 12 sessions. This treatment consists of 8 modules, each session is one hour long.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanyaran School-Pooyesh School
Full name of responsible person
Saman Ezzati
Street address
Qaradian Street
City
Sanandaj
Province
Kurdistan
Postal code
6617775864
Phone
+98 87 3562 3220
Email
samanezatii1372@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Kordestan
Full name of responsible person
Jamal Mohamadi
Street address
Qaradian Street
City
Sanandaj
Province
Kurdistan
Postal code
6617775864
Phone
+98 87 3562 3220
Email
samanezatii1372@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Kordestan
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
The University of Kordestan
Full name of responsible person
Saman Ezzati
Position
Senior students
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Qaradian Street
City
Sanandaj
Province
Kurdistan
Postal code
6617775864
Phone
+98 87 3562 3220
Email
samanezatii1372@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Kordestan
Full name of responsible person
Saman Ezzati
Position
Senior students
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Qaradian Street
City
Sanandaj
Province
Kurdistan
Postal code
6617775864
Phone
+98 87 3562 3220
Email
samanezatii1372@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of kurdestan
Full name of responsible person
Saman Ezzati
Position
Senior students
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Qaradian Street
City
Sanandaj
Province
Kurdistan
Postal code
6617775864
Phone
+98 87 3562 3220
Email
samanezatii1372@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the main message and the like will be shared.
When the data will become available and for how long
Start of access period from 1401مم
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Acquire scientific information in the framework laws
From where data/document is obtainable
SAMAN EZATI
samanezatii1372@gmail.com
What processes are involved for a request to access data/document