The effectiveness of emotion regulation therapy on decentering, difficulty in emotion regulation and symptoms people with social anxiety disorder comorbid with generalized anxiety disorder
Investigating the effect of emotion regulation treatment on symptoms of social anxiety disorder comorbid with generalized anxiety disorder
Design
The clinical trial has an intervention group, a control group, and a blind strain, which were randomly assigned to the control and intervention groups
Settings and conduct
The statistical population of the study includes all patients with SAD comorbid with GAD who refer to psychotherapy clinics in Shiraz. These patients are selected if they are volunteers and considering the entry and exit criteria.30 people from the mentioned community were selected by available sampling method and were randomly divided into two control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion: Diagnosis of comorbid SAD with GAD based on structured clinical interview for DSM-5
Exclusion: Suffering from severe clinical disorders such as psychosis, personality disorders and substance abuse disorder or other axis I and II disorders as the main diagnosis, simultaneous participation in other psychotherapy sessions, receiving drug therapy and three sessions of absence during treatment.
Intervention groups
Intervention group: The group of patients who are treated with emotion regulation therapy. Control group: the group of patients who do not receive any intervention
Main outcome variables
Symptoms of social anxiety disorder comorbid with generalized anxiety disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221214056812N1
Registration date:2023-05-04, 1402/02/14
Registration timing:prospective
Last update:2023-05-04, 1402/02/14
Update count:0
Registration date
2023-05-04, 1402/02/14
Registrant information
Name
Soodeh Shadkam
Name of organization / entity
Bu-Ali Sina University
Country
Iran (Islamic Republic of)
Phone
+98 81 3829 2310
Email address
sshadkam5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-10, 1402/02/20
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of emotion regulation therapy on decentering, difficulty in emotion regulation and symptoms people with social anxiety disorder comorbid with generalized anxiety disorder
Public title
The effectiveness of emotion regulation therapy on symptoms people with social anxiety disorder comorbid with generalized anxiety disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of SAD comorbid with GAD
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, a simple random method will be used, in this way, the names of the volunteers will be placed in an envelope, and the names of 15 people will be randomly drawn, and these will be the intervention group, and the rest will be the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
None of the sampled people will know about randomization and the process of allocation to groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Bu-Ali Sina University
Street address
Bu-Ali Sina university of Hamadan, Chaharbagh Shahid Mostafa Ahmadi Roshan, Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Approval date
2022-12-13, 1401/09/22
Ethics committee reference number
IR.BASU.REC.1401.044
Health conditions studied
1
Description of health condition studied
Social Anxiety Disorder comorbid with General Anxiety Disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Symptoms of social anxiety disorder
Timepoint
Pre-test, post-test
Method of measurement
Social interaction anxiety scale
2
Description
Symptom of general anxirty disorder
Timepoint
Pre-test, post-test
Method of measurement
General anxirty disorder scale-7
Secondary outcomes
1
Description
Anxiety general distress
Timepoint
Pre-test, post-test
Method of measurement
Mind and anxiety symptom questionnaire (short form)
2
Description
Anxiety arousal
Timepoint
Pre test, post test
Method of measurement
Mind and anxiety symptom questionnaire (short form)
3
Description
Worry
Timepoint
Pre test, post test
Method of measurement
Penn state worry questionnaire
4
Description
Negative repetitive thinking
Timepoint
Pre test, post test
Method of measurement
Perseverative thinking questionnaire
5
Description
Decentering
Timepoint
Pre test, post test
Method of measurement
Experiences questionnaire
6
Description
Difficulty in emotion regulation
Timepoint
Pre test, post test
Method of measurement
Difficulties in emotion regulation scale
Intervention groups
1
Description
Intervention group: They receive 8 sessions of emotional regulation group therapy, each session of 90 minutes and on a weekly basis.
Category
Behavior
2
Description
Control group: without therapy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Reza Sahami professional clinic
Full name of responsible person
Soodeh Shadkam
Street address
2 Abivardi St, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
۷۱۹۴۷-۳۷۴۶۱
Phone
+98 71 3626 9121
Email
sshadkam5@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu_Ali Sina University
Full name of responsible person
Abbas Aflatuni
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Bu-Ali Sina University, Faculty of Economics, ministry of science
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Phone
+98 81 3830 3208
Email
a.aflatooni@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu_Ali Sina 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
Bu-Ali Sina University of Hamadan
Full name of responsible person
Soodeh shadkam
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Phone
+98 81 3838 1601
Email
sshadkam5@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu-Ali Sina University of Hamadan
Full name of responsible person
Soodeh Shadkam
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street, Faculty of Economics, Department of Psychology
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Phone
+98 81 3838 1601
Email
sshadkam5@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bu-Ali Sina University of Hamadan
Full name of responsible person
Soodeh shadkam
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street، Faculty of Economics, Department of Psychology
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Phone
+98 81 3838 1601
Email
sshadkam5@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
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
Only data related to the final result is accessible
When the data will become available and for how long
Six months after the results are published
To whom data/document is available
Psychologist and psychiatrist researchers and experts
Under which criteria data/document could be used
The use of documents is allowed only for further research
From where data/document is obtainable
Soodeh Shadkam , Email: sshadkam5@gmail.com
What processes are involved for a request to access data/document