Comparing The Efficacy Of Metacognitive Group Therapy And Cognitive - Behavioral GroupTherapy On Reducing Of The Symptoms And Metacognitive Factors Of Social Anxiety Disorder In Students:Double Blind Randomized Clinical Trial.
Comparing The Efficacy Of Metacognitive Group Therapy And Cognitive-Behavioral Group Therapy On Reducing Of The Symptoms And Metacognitive Factors Of Social Anxiety Disorder In Students.
Design
This clinical trial has two intervention groups and one control group, double blind and randomized ones.
Settings and conduct
After a diagnostic interview by a psychiatrist, patients who are diagnosed with social anxiety disorder are assigned randomly into intervention1, intervention2 and control groups. Evaluation is also performed three months after the intervention. The place of interview and intervention is the Department of Psychiatry and Clinical Psychology of Zanjan University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1. Tendency to participate in research;
2. A score of between 21 and 40 (mild to moderate social anxiety) in the SPIN;
3. 18 years and older;
4. Residence in Zanjan during research;
5. Being a student.
Exclusion criteria:
1. At the same time receive psychological treatment;
2. Absence of more than two continuous sessions in therapeutic sessions;
3. Lack of participation in one of the three stages of evaluation;
4. History of psychosis, alcohol related disorders, bipolar disorder and personality disorders;
5.At the same time taking psychiatric medications.
Intervention groups
The first group will receive cognitive behavioral group therapy and the second group will receive metacognitive group therapy. The third group will not take any intervention on them.
Main outcome variables
Symptoms of social anxiety disorder; social phobia; social interaction; fear of negative evaluation; cognitive-attentional syndrome; negative meta-cognitive beliefs about risk and uncontrolledness; positive beliefs about worry; cognitive confidence; cognitive self-awareness; need for thought control
General information
Reason for update
Acronym
CBT & MCT
IRCT registration information
IRCT registration number:IRCT20190518043626N1
Registration date:2019-05-23, 1398/03/02
Registration timing:prospective
Last update:2019-05-23, 1398/03/02
Update count:1
Registration date
2019-05-23, 1398/03/02
Registrant information
Name
Fatemeh Rezaei Khodadadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3353 3400
Email address
fatma.rezaei72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-01, 1398/03/11
Expected recruitment end date
2019-07-17, 1398/04/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing The Efficacy Of Metacognitive Group Therapy And Cognitive - Behavioral GroupTherapy On Reducing Of The Symptoms And Metacognitive Factors Of Social Anxiety Disorder In Students:Double Blind Randomized Clinical Trial.
Public title
Comparing The Efficacy Of Metacognitive Group Therapy And Cognitive - Behavioral GroupTherapy On Reducing Of The Symptoms And Metacognitive Factors Of Social Anxiety Disorder In Students.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency to participate in research.
A score of between 21 and 40 (mild to moderate social anxiety) in SPIN.
Age of 18 years and older.
Residence in Zanjan city during research.
Being a student.
Exclusion criteria:
At the same time receive psychological treatment.
Absence of more than two continuous sessions in therapeutic sessions.
Lack of participation in one of the three stages of evaluation.
History of psychosis, alcohol related disorders, bipolar disorder and personality disorders.
At the same time taking psychiatric medications.
Score 15 to 25 in BDI-II.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
After diagnosis by a specialist, patients are assigned to treatment groups 1, 2, and control group, regardless of their specific characteristics, by software, so that all participants have the odds of being in groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting a sample, none of the sample individuals will know about the randomization process and allocation process to the groups. The data analyst is selected outside of the study, and all data will be encoded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of zanjan University of Medical Sciences .
Street address
Crossroads of Saadi, Gate of the Citadel, Shahid Beheshti Hospital.
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Approval date
2019-05-15, 1398/02/25
Ethics committee reference number
IR.ZUMS.REC.1398.036
Health conditions studied
1
Description of health condition studied
social anxiety disorder
ICD-10 code
F40.1
ICD-10 code description
Social phobias
Primary outcomes
1
Description
Symptoms of Social Anxiety Disorder.
Timepoint
Pre-test, post-test and follow-up (three months after the post-test).
Method of measurement
Conver social phobia Questionnaire(SPIN) and social interaction anxiety scale(SIAS).
2
Description
social phobia.
Timepoint
Pre-test, post-test and follow-up (three months after the post-test).
Method of measurement
Conver social phobia Questionnaire(SPIN).
3
Description
Social interaction.
Timepoint
Pre-test, post-test and follow-up (three months after the post-test).
Method of measurement
social interaction anxiety scale(SIAS).
4
Description
Fear of negative evaluation.
Timepoint
Pre-test, post-test and follow-up (three months after the post-test).
Method of measurement
Fear of negative evaluation of short form questionnaire(FNES-B).
5
Description
Cognitive-attentional syndrome.
Timepoint
Pre-test, post-test and follow-up (three months after the post-test).
Method of measurement
CAS-1.
6
Description
Negative metacognitive beliefs about risk and uncontrollability.
Timepoint
Pre-test, post-test and follow-up (three months after the post-test).
Method of measurement
MCQ-30.
7
Description
Positive metacognitive beliefs about worries.
Timepoint
Pre-test, post-test and follow-up (three months after the post-test).
Method of measurement
MCQ-30.
8
Description
Cognitive Confidence.
Timepoint
Pre-test, post-test and follow-up (three months after the post-test).
Method of measurement
MCQ-30.
9
Description
Cognitive self-awareness.
Timepoint
Pre-test, post-test and follow-up (three months after the post-test).
Method of measurement
MCQ-30.
10
Description
Need to control thought.
Timepoint
Pre-test, post-test and follow-up (three months after the post-test).
Method of measurement
MCQ-30.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Cognitive-behavioral group therapy Based on Hoffman model.
Category
Behavior
2
Description
Intervention group:Metacognitive group therapy.
Category
Behavior
3
Description
Control group:No intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan University of Medical Sciences.
Full name of responsible person
saeedeh zenoozian
Street address
Azadi Square, Zanjan University of Medical Sciences.
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Phone
+98 24 3342 0670
Email
fatma.rezaei72@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
seeded zenoozian
Street address
Azadi Square, Zanjan University of Medical Sciences.
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 2403
Email
zenoozian@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
saeedeh zenoozian
Position
Assistant Professor.
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Crossroads of Saadi, Gate of the Citadel, Shahid Beheshti Hospital.
City
Zanjan.
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 2403
Email
zenoozian@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
saeedeh zenoozian
Position
Assistant Professor.
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Crossroads of Saadi, Gate of the Citadel, Shahid Beheshti Hospital.
City
Zanjan.
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3354 2403
Email
zenoozian@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Fatemeh Rezaei Khodadadi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Crossroads of saadi, gate of the citadel ,shahid beheshti haspital
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3353 3400
Fax
Email
fatma.rezaei72@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
All information about the original outcome will be published with the likes of it.
When the data will become available and for how long
Get started since 1400.
To whom data/document is available
Researchers working in academia.
Under which criteria data/document could be used
Access to the documentation is possible for other researchers.
Access to the documentation is possible with the researcher.
From where data/document is obtainable
Shaheed Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr. Saeedeh Zooszian. Tel: 09032180053 Zanjan Shahid Beheshti Hospital, Department of Clinical Psychology, Fatemeh Rezaei Khodadadi. Tel: 09130514827
What processes are involved for a request to access data/document
The required documentation will be shared only by mentioning the reason for the request by email or telephone.