Determining the effectiveness of emotional schema therapy on generalized anxiety disorder
Design
The clinical trial of single-subject designs, the second phase will be conducted on 3 patients, one person will be considered as a control, one head will be blinded, and the rand function of Excel software will be used for randomization.
Settings and conduct
At first, the emotional schemas of patients with generalized anxiety disorder will be identified through a questionnaire, then three people will be randomly selected and one person will be considered as a control. First, the patients' baseline is determined through the pre-test, then they will be placed in the treatment process, and the post-test and visual charts will show the changes compared to the baseline. And finally, the effectiveness of the treatment is checked through the examination of visual charts and the comparison of the pre-test and post-test scales of pervasive anxiety and emotional schemas.
Participants/Inclusion and exclusion criteria
Being at least 20 years old and having at least a diploma.
Having a diagnosis of generalized anxiety disorder and
Having no other psychological disorder
Not having a physical disorder and Not under drug treatment
Intervention groups
This research will be a single-subject study and three people will be selected based on the entry criteria and will undergo therapeutic intervention based on the emotional schema therapy protocol, and the effectiveness of the protocol on the symptoms of generalized anxiety disorder will be investigated
Main outcome variables
Determine the effectiveness of emotional schema therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180306038973N1
Registration date:2023-01-15, 1401/10/25
Registration timing:prospective
Last update:2023-01-15, 1401/10/25
Update count:0
Registration date
2023-01-15, 1401/10/25
Registrant information
Name
Maryam Morvaridi
Name of organization / entity
Shahed University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 51 3845 5721
Email address
morvaridi89@mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-12, 1401/12/21
Expected recruitment end date
2023-04-10, 1402/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Feasibility, adaptability and efficacy of the emotional schema model in people with generalized anxiety disorder
Public title
Efficacy of emotional schema therapy on generalized anxiety disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are diagnosed with generalized anxiety disorder
Exclusion criteria:
having physical illness
Having another psychological disorder
Being treated with medication
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
3
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
Research Ethics committee of Shahed University
Street address
Khalig Fars Highway, Shahed University,Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2023-01-02, 1401/10/12
Ethics committee reference number
IR.SHAHED.REC.1401.125
Health conditions studied
1
Description of health condition studied
General Anxiety Disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
The generalized anxiety score in the generalized anxiety scale
Timepoint
Measuring generalized anxiety at the beginning of the study and after ten treatment sessions
Method of measurement
Questionnaire to measure generalized anxiety
Secondary outcomes
empty
Intervention groups
1
Description
The emotional schema therapy protocol was published by Leahy in 2015, which focuses on 14 emotional schemas and uses therapy techniques, including emotion regulation, mindfulness, meta cognitive, and acceptance techniques, to change each emotional schema.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Warsh Psychological Clinic
Full name of responsible person
Rasol Roshan
Street address
No.5,Patrice street,Sattarkhan street
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 6657 3387
Email
rasolroshan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Rasol Roshan
Street address
Highway Khalig Fars, Shahed University, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2433
Email
rasolroshan@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed 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
Shahed University
Full name of responsible person
Rasol Roshan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Khalig Fars Highway , Shahed University, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2433
Email
rasolroshan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Rasol Roshan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Khalig Fars Highway , Shahed University, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 2433
Email
rasolroshan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Maryam Morvaridi
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khalig Fars highway, Shahed University, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 51 3845 5721
Email
mm.morvaridi88@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
All data can be shared after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Access will be available to researchers working in universities and scientific centers
Under which criteria data/document could be used
People requesting data should be experts in the field of psychological issues
Adhere to the principles of confidentiality
From where data/document is obtainable
mm.morvaridi88@gmail.com
rasolroshan@yahoo.com
What processes are involved for a request to access data/document
Emailing and introducing themselves
Explanation of the reason for requesting information
The waiting time for reviewing the application and providing a response is one month