Protocol summary

Study aim
Determine the effectiveness of mindfulness-based cognitive therapy on Psychological symptoms of students with social anxiety disorder
Design
Clinical trial with control ,Not blind, randomized
Settings and conduct
Counseling Center of Kermanshah University of Medical Sciences-Students receive 8 sessions of group therapy.
Participants/Inclusion and exclusion criteria
The main inclusion criterion: The person has a social anxiety disorder The main inclusion criteria: Having a person with other mental disorders
Intervention groups
12 people receive mindfulness-based cognitive therapy, and12 subjects are listed waiting list.
Main outcome variables
Social Anxiety Disorder

General information

Reason for update
Acronym
MBCT
IRCT registration information
IRCT registration number: IRCT20190222042797N1
Registration date: 2019-03-04, 1397/12/13
Registration timing: prospective

Last update: 2019-03-04, 1397/12/13
Update count: 0
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
mohsen mohammadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3832 7816
Email address
mohammadpour5711@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-18, 1398/01/29
Expected recruitment end date
2019-05-19, 1398/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study of efficacy of Mindfulness-based cognitive therapy on Psychological symptoms of students with social anxiety disorder
Public title
A study of efficacy of Mindfulness-based cognitive therapy on Psychological symptoms of students with social anxiety disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 18 years of age having at least 3 years of secondary education A person with social anxiety disorder based on a diagnostic interview by a psychologist Do not suffer from a serious psychological disorder (such as mood and psychiatric disorders) Motivation and satisfaction for participation during treatment and research implementation
Exclusion criteria:
The apparent risk of current suicide Not receiving psychological treatment in the past year Having a history of drug abuse or dependence now and over a year before starting treatment Unwillingness to attend research meetings
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
By simple random method individuals are assigned to the control and test groups using sealed envelope
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 Kermanshah University of Medical Sciences
Street address
Oil field, Facing Taleghani Hospital
City
kermanshah
Province
Kermanshah
Postal code
56423-22222
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.KUMS.REC.1397.952

Health conditions studied

1

Description of health condition studied
social anxiety
ICD-10 code
F41.8
ICD-10 code description
Other specified anxiety disorders

Primary outcomes

1

Description
social anxiety
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
Social Interaction Anxiety Scale

2

Description
Interpersonal sensitivity
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
interpersonal sensitivity measure

3

Description
Self-Compassion
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
Self-Compassion Inventory

4

Description
Sensitivity to anxiety
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
Anxiety Sensitivity Inventory -3

5

Description
External Shame
Timepoint
At the beginning of the study, after the study (after the end of the intervention) and two months after the study
Method of measurement
External Shame scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: MBCT was carried out according to a manual by Segal et al. (2002) developed for the treatment of chronic depression.The intervention consisted of 8 weekly 2-hour sessions in groups with up to 12 participants.components are mindfulness meditation techniques such as the bodyscan
Category
Behavior

2

Description
Control group: 12 people are on the waiting list and they will be given self-help books after the end of the intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Mohsen Mohammadpour
Street address
Kermanshah-Shahid Shiroodi Blvd.-Imam Reza Hospital- Medical school
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 5925
Email
mohammadpour5711@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Headquarte, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 5925
Email
fnajafi@kums.ac.ir
Grant name
Kermanshah University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohsen Mohammadpour
Position
MSc
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kermanshah-Shahid Shiroodi Blvd.-Imam Reza Hospital- Medical school
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 5925
Email
mohammdpour5711@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Aliakbar Foroughi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Kermanshah-Shahid Shiroodi Blvd.-Imam Reza Hospitantel- Medical School
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 5925
Email
foroughi-2002@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sahar Pouyanfard
Position
MSc
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kermanshah-Shahid Shiroodi Blvd.-Imam Reza Hospitantel- Medical School
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 5925
Email
saharpooyanfard@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
The participants are unclear
Study Protocol
No - There is not 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
No - There is not 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
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