Effectiveness of group therapy based on acceptance and commitment with psychodrama components on social anxiety, shyness and fear of negative evaluations in people with social anxiety disorder
Determination the effectiveness of group therapy based on acceptance and commitment with psychodrama components on social anxiety, shyness and fear of negative evaluations in students with social anxiety symptoms
Design
The clinical trial has an intervention group and three control group, randomized and not blind
Settings and conduct
The aim of this study was to determination the effectiveness of group therapy based on ACT with psychodrama components on social anxiety, shyness and fear of negative evaluations in students with social anxiety symptoms in Torbat Heydarieh University of Medical Sciences. At first, 48 patients were selected through simple random sampling and then assigned to an intervention group and three control groups using the Random block split method .The intervention group received therapeutic course based on the protocol that fit into social anxiety disorder, by the researcher is designed and used experimentally.The first control group at this stage will receive only ACT treatment.The second control group at this stage will only receive the psychodrama treatment.The third control group will not receive any treatment at this stage.
Participants/Inclusion and exclusion criteria
Age of 18 to 60 years
Earn the minimum score in a Shyness Questionnaire
Earn the minimum cut score in Social Anxiety Inventory
Earn the minimum score in a questionnaire for fear of negative evaluations
Intervention groups
The intervention group received therapeutic course based on the protocol that fit into social anxiety disorder, by the researcher is designed and used experimentally.The first control group at this stage will receive only ACT treatment.The second control group at this stage will only receive the psychodrama treatment.The third control group will not receive any treatment at this stage.
Main outcome variables
social anxiety, shyness and fear of negative evaluation in students
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181009041282N3
Registration date:2018-12-01, 1397/09/10
Registration timing:registered_while_recruiting
Last update:2018-12-01, 1397/09/10
Update count:0
Registration date
2018-12-01, 1397/09/10
Registrant information
Name
Maliheh Eshaghzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 6011
Email address
eshaghzadehm2@thums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-21, 1397/08/30
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of group therapy based on acceptance and commitment with psychodrama components on social anxiety, shyness and fear of negative evaluations in people with social anxiety disorder
Public title
Effectiveness of group therapy based on acceptance and commitment with psychodrama components in people with social anxiety disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Earn the minimum score in a Shyness Questionnaire
Earn the minimum cut score in Social Anxiety Inventory
Earn the minimum score in a questionnaire for fear of negative evaluations
Exclusion criteria:
Unwillingness to cooperate in the study
Use of other psychological treatment
Having mental or nervous disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
At first, 48 patients were selected through simple random sampling and then assigned to an intervention group and three control groups using the Random block split method and Randomization.com site.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Torbat Heydarieh University of Medical Sciences
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.THUMS.REC.1397.008
Health conditions studied
1
Description of health condition studied
Social anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
2
Description of health condition studied
Shyness
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Fear of negative evaluations
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Social Phobia: Refers to the obvious and continuous fear of social and functional situations that results in a negative evaluation of the participation in communication situations and can lead to the remoteness and separation of the individual from the community.
Timepoint
The beginning of the study and after the intervention
Method of measurement
Social Phobia Inventory
2
Description
Shyness : The tendency to avoid social interactions and feelings of failure are called proper participation in shyness social situations.
Timepoint
The beginning of the study and after the intervention
Method of measurement
Stanford Shyness Questionnaire
3
Description
Fear of negative evaluation: The feeling of apprehension and concern about others' assessments is the concern raised by these negative assessments, expectations and expectations that a person is about others and that others will only judge him negatively, Gets
Timepoint
The beginning of the study and after the intervention
Method of measurement
Fear of Negative Evaluation Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group (combined psychotherapy group) received 12 sessions of 90 minutes and a weekly 2 sessions based on the protocol (based on the protocol for ACT treatment of Hayes and Strosahl and the psychodrama-Dayton protocol) that fit into social anxiety disorder, by the researcher is designed and used experimentally. Acceptance and commitment therapy (ACT) encourages a person to accept what is beyond his control and commitment to social goals. In fact, ACT uses acceptance processes, mindfulness, and change in behavior and commitment to create psychological flexibility.The psychodrama treatment protocol is a group therapy approach that highlights personality traits, interpersonal communication, psychological conflicts, and disorders of individuals through special methods of presentation.
Category
Behavior
2
Description
Control group: The first control group at this stage will receive only ACT treatment for in 10 sessions of two hours for 10 weeks. Acceptance and commitment therapy (ACT) encourages a person to accept what is beyond his control and commitment to social goals. In fact, ACT uses acceptance processes, mindfulness, and change in behavior and commitment to create psychological flexibility.
Category
Behavior
3
Description
Control group: The second control group at this stage will only receive the psychodrama treatment in 10 sessions of two hours for 10 weeks. The psychodrama treatment protocol is a group therapy approach that highlights personality traits, interpersonal communication, psychological conflicts, and disorders of individuals through special methods of presentation.
Category
Behavior
4
Description
Control group: The third control group will not receive any treatment at this stage.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Torbat Heydarieh University of Medical Sciences
Full name of responsible person
Samaneh Eshaghzadeh
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6011
Email
PR@thums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Hasan Azhdari Zarmehri
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6114
Email
azhdarih1@thums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Torbate-Heidaria University of Medical Sciences
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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Seddigheh Abbaspour
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 3118
Email
AbbaspourS1@thums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Samaneh Eshaghzadeh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6011
Email
s.eshaghzadeh0@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Maliheh Eshaghzadeh
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Razi street
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516915169
Phone
+98 51 5222 6011
Email
m.eshaghzadeh93@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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