Comparison of the effectiveness of integrated cognitive-behavioral therapy with transdiagnostic treatment on symptoms of patients with generalized anxiety disorder comorbid with depression
Comparison of the effectiveness of integrated cognitive-behavioral therapy with Transdiagnostic Treatment on symptoms of patients with generalized anxiety disorder comorbid with depression
Design
Competitive validation of a two-group quasi-experimental design (group 1): integrated treatment intervention group and (group 2): single diagnostic treatment group in a single case with different subjects and continuous assessment. Targeted and random sampling in two groups using random numbers.
Settings and conduct
Once the baseline in the research variables was determined, in the next stage, the interventions were performed individually in one-hour weekly sessions. Subjects in both groups were evaluated to follow the results of treatment in the time intervals of the third, sixth, eighth and tenth sessions (completion of treatment sessions) and one-month follow-up with research scales.
Participants/Inclusion and exclusion criteria
Education cycle and age range 20 to 55 years, the main and primary diagnosis of generalized anxiety disorder based on diagnostic interview and generalized anxiety questionnaire, having symptoms of depression syndrome based on diagnostic interview and depression questionnaire, no disease or other psychiatric diagnosis other than Generalized Anxiety Disorder And Depression. Reluctance and satisfaction from participating in the study were also conditions for not entering the study.
Comparison of the effectiveness of integrated cognitive-behavioral therapy with transdiagnostic treatment on symptoms of patients with generalized anxiety disorder comorbid with depression
Public title
Comparison of the effectiveness of integrated cognitive-behavioral therapy with transdiagnostic treatment on symptoms of patients with generalized anxiety disorder comorbid with depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Third grade middle school education
Age range 20 to 55 years
Main and initial diagnosis of generalized anxiety disorder based on diagnostic interview and generalized anxiety questionnaire
Having sub-syndromic symptoms of depression based on diagnostic interview and depression questionnaire
No illness or psychiatric diagnosis other than generalized anxiety disorder and depression
Exclusion criteria:
Dissatisfaction and unwillingness to participate in research work
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Actual sample size reached:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
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
University of Isfahan
Street address
University of Isfahan, Daneshgah street
City
isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2019-07-14, 1398/04/23
Ethics committee reference number
IR.UI.REC.1398.013
Health conditions studied
1
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Generalized anxiety disorder symptoms
Timepoint
Third, sixth, eighth and tenth sessions and one month follow-up
Method of measurement
GAD-7 scales
2
Description
Worry
Timepoint
Third, sixth, eighth and tenth sessions and one month follow-up
Method of measurement
Penn State Worry Questionnaire (PSWQ)
3
Description
Depression
Timepoint
Third, sixth, eighth and tenth sessions and one month follow-up
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Integrated cognitive behavioral therapy. One-hour weekly sessions of integrated cognitive-behavioral therapy in a single case
Category
Behavior
2
Description
Intervention group: Transdiagnostic treatment. One-hour weekly Transdiagnostic treatment sessions on a case-by-case basis.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Isfahan
Full name of responsible person
Farzad ghaderi
Street address
University of Isfahan, Daneshgah street
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2128
Email
f.ghaderi@edu.ui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, University of Isfahan
Full name of responsible person
Dr Rasoul Roknizadeh
Street address
University of Isfahan, Daneshgah street
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2128
Email
f.ghaderi@edu.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, University of Isfahan
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
University of Isfahan
Full name of responsible person
Farzad Ghaderi
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Isfahan, Daneshgah street
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2128
Email
f.ghaderi@edu.ui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Uiversity of Isfahan
Full name of responsible person
Farzad Ghaderi
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Isfahan, Daneshgah street
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2128
Email
f.ghaderi@edu.ui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Farzad Ghaderi
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University of Isfahan, Daneshgah street
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2128
Email
f.ghaderi@edu.ui.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Individual data related to the main outcomes of the study without mentioning the demographic characteristics of the subjects
When the data will become available and for how long
6 months after the publication of the results
To whom data/document is available
Academic researchers after authentication
Under which criteria data/document could be used
Requesting the use of data is permitted only for use in cross-cultural surveys or meta-analysis studies.
From where data/document is obtainable
The request should be sent to Farzad Ghaderi's email address.
email: ghaderi68@yahoo.com
What processes are involved for a request to access data/document
Data information will be provided to individuals via email after the application is evaluated.