The Efficacy of Unified Trans diagnostic Therapy in Reducing Worry, Anxiety, Depressive Sympotom and Emotion Regulation in Patients With Generalized Anxiety Disorder
The Efficacy of Unified Trans diagnostic Therapy in Reducing Worry, Anxiety, Depressive Sympotom and Emotion Regulation in Patients With Generalized Anxiety Disorder
Design
Semi-experimental research design, pre-test and post-test, two-tiered, twenty patients, randomly divided into two experimental and control groups, each with 10 patients
Settings and conduct
The diagnosis was made by a psychiatrist.
Psychotherapy was performed by a clinical psychologist.
Patients entered the treatment groups with satisfaction and using random numbers table.
Anxiety, depression, worry and emotional regulation questionnaires were administered to the two groups.
Pre-test and post-test were performed on both groups.
The control group received no intervention.
Experimental approach was used in the experimental group.
The approach was individual.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Being resident in Sanandaj;
Having generalized anxiety disorder criterion;
Having motivation and satisfaction for attending in sessions;
level of education: at least high school diploma;
Exclusion criteria:
Diagnosis of any comorbid disorders (except for anxiety and depression);
having major depressive disorder;
having psychotic symptoms and drug abuse and suicidal thoughts:
having all symptoms of personality disorders.
Intervention groups
Experimental approach was used in the intervention group individually. The control group received no intervention. both groups received medication therapy.
Main outcome variables
Anxiety and depression and worry
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100614004178N3
Registration date:2020-01-26, 1398/11/06
Registration timing:retrospective
Last update:2020-01-26, 1398/11/06
Update count:0
Registration date
2020-01-26, 1398/11/06
Registrant information
Name
Abolfazl Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 9151
Email address
amohammadi@stu.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-26, 1397/01/06
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Unified Trans diagnostic Therapy in Reducing Worry, Anxiety, Depressive Sympotom and Emotion Regulation in Patients With Generalized Anxiety Disorder
Public title
The Efficacy of Unified Transdiagnostic Therapy in Reducing Worry, Anxiety, Depressive Sympotom and Emotion Regulation in Patients With Generalized Anxiety Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being resident in sanandaj)
Having generalized anxiety disorder symptoms based on psychiatric or clinical psychologists diagnosis according to SCID-1
Having motivation and satisfaction for attending in treatment sessions
level of education :Having at least high school diploma
Exclusion criteria:
diagnosis of any comorbid disorders except for anxiety and depression which has been mentioned in the research
having major depressive disorder (MDD)
having psychotic symptoms and drug abuse and suicidal thoughts
having all symptoms of personality disorders according to DSM-5
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be divided into two experimental and control groups using simple random sampling using sealed envelopes. This will provide 20 envelopes with 10 letters on the letter A (the intervention group) and 10 letters on the cards B (control group) and put in the envelope. The envelopes will be mixed together and randomly one of the envelopes will be selected by the patient and assigned to one of the groups accordingly.
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
Ethics Committee of Kurdestan University of Medical Sciences
pre and post treatment and after 3 month fallow up
Method of measurement
Beck anxiety inventory
2
Description
depression
Timepoint
pre and post treatment and after 3 month fallow up
Method of measurement
beck depression inventory
3
Description
woryy
Timepoint
pre and post treatment and after 3 month fallow up
Method of measurement
Pennsylvania worry questionnaire
4
Description
emotion regulation
Timepoint
pre and post treatment and after 3 month fallow up
Method of measurement
difficulties in emotion regulation questionnaire
Intervention groups
1
Description
Intervention group: En Experimental was participated in transdiagnostic therapy at 8-12 weeks for 1 hours. Therapeutic components of transdiagnostic therapy were including: home work, Positive and Negative Feedback, Summary, Three-System Thriller Model, Emotional Components, Cognitive Distortions, Automatic Thoughts, Ingection PracticeThinking, Downward Arrow, Dysfunctional Attitude Classification, LogicalAnalysis, Analysis of the Utility of Beliefs./ Pre-test and finally post-test were performed on the experimental group
Category
Treatment - Other
2
Description
Control group: In the control group, there was no intervention,Pre-test and post-test were performed on control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sanandaj Welfare Psychological Center
Full name of responsible person
Shelir Kolahzari
Street address
Safari St.
City
Sanandaj
Province
Kurdistan
Postal code
6618654658
Phone
+98 87 3362 6183
Email
shelir.kolahzari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shelir Kolahzari
Full name of responsible person
Shelir Kolahzari
Street address
Sharif Abad Street
City
Sanandaj
Province
Kurdistan
Postal code
6617934584
Phone
+98 87 3362 6183
Email
shelir.kolahzari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shelir Kolahzari
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shelir Kolahzari
Full name of responsible person
Shelir Kolahzari
Position
Mental Health
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Sharif Abad St.
City
Sanandaj
Province
Kurdistan
Postal code
6617934584
Phone
+98 87 3362 6183
Email
shelir.kolahzari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kurdestan University of Medical Science
Full name of responsible person
Shelir Kolahzari
Position
M.A
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Sharif Abad St.
City
Sanandaj
Province
Kurdistan
Postal code
6617934584
Phone
+98 87 3362 6183
Email
Shelir.kolahzari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Shelir Kolahzari
Position
Mental Health
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Nahid 4.Ave, Sharifabad-St,
City
Sanandaj
Province
Kurdistan
Postal code
6617934584
Phone
+98 87 3362 6183
Email
shelir.kolahzari@gmail.com
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
dissemination of patient information is not necessary
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
original article in journal
When the data will become available and for how long
after 6month post treatment
To whom data/document is available
report is accessible for researchers
Under which criteria data/document could be used
researcher in this field
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document