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Protocol summary
Social anxiety; Self-compassion; Acceptance and action; External shame; Difficulty in regulating excitement
Social anxiety; Self-compassion; Acceptance and action; External shame; Difficulty in regulating excitement; Interpersonal sensitivity
Social anxiety; Self-compassion; Acceptance and action; External shame; Difficulty in regulating excitement; Interpersonal sensitivity
اضطراب اجتماعی؛ شفقت به خود؛ پذیرش و عمل؛ شرم بیرونی؛ دشواری در تنظیم هیجان
اضطراب اجتماعی؛ شفقت به خود؛ پذیرش و عمل؛ شرم بیرونی؛ دشواری در تنظیم هیجان؛ حساسیت بین فردی
اضطراب اجتماعی؛ شفقت به خود؛ پذیرش و عمل؛ شرم بیرونی؛ دشواری در تنظیم هیجان؛ حساسیت بین فردی
Secondary outcomes
#1
empty
Interpersonal sensitivity
Interpersonal sensitivity
empty
حساسیت بین فردی
حساسیت بین فردی
empty
A week before the intervention, one week after the intervention, two months after the intervention
A week before the intervention, one week after the intervention, two months after the intervention
empty
یک هفته قبل شروع مداخله، یک هفته بعد اتمام مداخله، دو ماه بعد از اتمام مداخله
یک هفته قبل شروع مداخله، یک هفته بعد اتمام مداخله، دو ماه بعد از اتمام مداخله
empty
Interpersonal Sensitivity Questionnaire
Interpersonal Sensitivity Questionnaire
empty
پرسش نامه حساسیت بین فردی
پرسش نامه حساسیت بین فردی
Recruitment centers
#1
Name of recruitment center - English: دانشگاه علوم پزشکی کرمانشاه
Name of recruitment center - Persian: Kermanshah University of Medical Sciences
Full name of responsible person - English: samad khoramnia
Full name of responsible person - Persian: صمد خرم نیا
Street address - English: Kermanshah-Shahid Shiroodi Blvd.-Imam Reza Hospital- Medical school
Street address - Persian: کرمانشاه-بلوار شهید شیرودی-جنب بیمارستان امام رضا (ع)-دانشکده پزشکی
City - English: kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6715847141
Phone: +98 84 3442 3968
Fax:
Email: khoramniya.samad369@gmail.vom
Web page address:
Name of recruitment center - English: Kermanshah University of Medical Sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی کرمانشاه
Full name of responsible person - English: Samad Khoramnia
Full name of responsible person - Persian: صمد خرم نیا
Street address - English: Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
Street address - Persian: کرمانشاه، بلوار شهید شیرودی، جنب بیمارستان امام رضا (ع)، دانشکده پزشکی
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6715847141
Phone: +98 84 3442 3968
Fax:
Email: khoramniya.samad369@gmail.vom
Web page address:
Name of recruitment center - English: دانشگاه علوم پزشکی کرمانشاهKermanshah University of Medical Sciences Name of recruitment center - Persian: Kermanshah University of Medical Sciencesدانشگاه علوم پزشکی کرمانشاه Full name of responsible person - English: samad khoramniaSamad Khoramnia Full name of responsible person - Persian: صمد خرم نیا Street address - English: Kermanshah-Shahid Shiroodi Blvd.-Faculty of Medicine, Imam Reza Hospital- Medical school, Shahid Shiroudi Blvd, Kermanshah Street address - Persian: کرمانشاه-، بلوار شهید شیرودی-، جنب بیمارستان امام رضا (ع)-، دانشکده پزشکی City - English: kermanshahKermanshah City - Persian: کرمانشاه Province: Kermanshah Country: Iran (Islamic Republic of) Postal code: 6715847141 Phone: +98 84 3442 3968 Fax: Email: khoramniya.samad369@gmail.vom Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Farid Najafi
Full name of responsible person - Persian: فرید نجفی
Street address - English: Headquarte, Shahid Beheshti Blvd, Kermanshah
Street address - Persian: کرمانشاه - خیابان شهید بهشتی - ساختمان مرکزی
City - English: kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6715847141
Phone: +98 84 3442 3968
Fax:
Email: khoramniya.samad369@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Farid Najafi
Full name of responsible person - Persian: فرید نجفی
Street address - English: Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah
Street address - Persian: کرمانشاه، خیابان شهید بهشتی، ساختمان مرکزی دانشگاه علوم پزشکی کرمانشاه
City - English: kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6715847141
Phone: +98 84 3442 3968
Fax:
Email: farid_n32@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Farid Najafi Full name of responsible person - Persian: فرید نجفی Street address - English: HeadquarteCentral Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah Street address - Persian: کرمانشاه -، خیابان شهید بهشتی -، ساختمان مرکزی دانشگاه علوم پزشکی کرمانشاه City - English: kermanshah City - Persian: کرمانشاه Province: Kermanshah Country: Iran (Islamic Republic of) Postal code: 6715847141 Phone: +98 84 3442 3968 Fax: Email: khoramniya.samad369farid_n32@gmail.comyahoo.com Web page address:
Protocol summary
Study aim
Determining the efficacy of acceptance and commitment therapy in improving psychological symptoms in patients with social anxiety disorder
Design
Clinical trial with control group, Not blinded, Randomized
Settings and conduct
This study is conducted at the counseling Center of Kermanshah University of Medical Sciences. Patients receive 12 sessions of acceptance and commitment therapy individually and weekly. The duration of each session is 90 minutes. To evaluate the follow up period again two months after the end of the intervention the subjects are evaluated. In order to evaluate the effects of treatment subjects will be evaluated one week before, one week after and two months after the end of the intervention respectively. The intervention is done by an experienced psychologist and based on Eifert and Forsyth protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having social anxiety disorder as the main diagnosis.
Exclusion criteria: current diagnosis of any comorbid mental disorders in axis 1 and 2 based on a psychiatrist's diagnostic interview.
Intervention groups
Intervention group: 12 people with social anxiety disorder will receive 12 sessions of treatment based on cceptance and commitment.
Control group: 12 people and do not receive any special treatment.
Main outcome variables
Social anxiety; Self-compassion; Acceptance and action; External shame; Difficulty in regulating excitement; Interpersonal sensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180421039369N1
Registration date:2018-09-16, 1397/06/25
Registration timing:retrospective
Last update:2020-05-02, 1399/02/13
Update count:1
Registration date
2018-09-16, 1397/06/25
Registrant information
Name
Nasrin Jaberghaderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 4622
Email address
nasrin.jaberghaderi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-18, 1397/01/29
Expected recruitment end date
2018-05-19, 1397/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of acceptance and commitment therapy in improving psychological symptoms in patients with social anxiety disorder
Public title
The assessment of acceptance and commitment therapy on social anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The main and primary diagnosis of social anxiety disorder based on anxiety disorder interview
Patient's agreement to participate in research
Lack of psychological therapy in the last year
No psychiatric medication intake during the past six months
No main and primary diagnosis of mood disorders and other anxiety disorders
Exclusion criteria:
Current diagnosis of any comorbid mental disorders in Axis 1 and 2 based on a psychiatrist's diagnostic interview
History of current substance dependence and over a year before the onset of treatment
Age
From 18 years old to 65 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
For randomizing assignment, the Simple Random method is used. 24 cards with the same appearance are provided. On 12 of cards the number 1 and on 12 of them the number 2 is written which represent the intervention group and the control group respectively. Then, one card is given to each qualified individual randomly and his assignment to the group is recorded. This process is continues until all individuals are assigned. It should be noted that participants are unaware of the nature of the numbers and type of intervention.
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
Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-05-21, 1397/02/31
Ethics committee reference number
IR.KUMS.REC.1397.085
Health conditions studied
1
Description of health condition studied
Social phobias
ICD-10 code
F40.1
ICD-10 code description
Social phobias
Primary outcomes
1
Description
Social phobia
Timepoint
A week before the intervention, one week after the intervention, two months after the intervention
Method of measurement
Spin social anxiety questionnaire
Secondary outcomes
1
Description
External shame
Timepoint
A week before the intervention, one week after the intervention, two months after the intervention
Method of measurement
External shame questionnaire
2
Description
Self-compassion
Timepoint
A week before the intervention, one week after the intervention, two months after the intervention
Method of measurement
Self compassion questionnaire
3
Description
Acceptance and action
Timepoint
A week before the intervention, one week after the intervention, two months after the intervention
Method of measurement
Acceptance and Action Questionnaire
4
Description
Difficult emotion regulation
Timepoint
A week before the intervention, one week after the intervention, two months after the intervention
Method of measurement
Difficult emotion regulation scale
5
Description
Interpersonal sensitivity
Timepoint
A week before the intervention, one week after the intervention, two months after the intervention
Method of measurement
Interpersonal Sensitivity Questionnaire
Intervention groups
1
Description
Intervention group: the intervention group consists of 12 individuals during the 12 sessions receiving Treatment based on acceptance and commitment individually according to eifert and forsyth protocol. This treatment has two main objectives: 1) Enhancing the power of accepting unpleasant thoughts and feelings that the patient does not have control over their existence or disappearance. 2) Commitment and action towards the kind of life that is valuable to him. In this treatment the concepts of acceptance, commitment, values and exposure to anxiety are trained and treatment sessions are held weekly and each session lasts 90 minutes during three months. After that, the follow-up period takes two months.
Category
Behavior
2
Description
Control group: consists of 12 people who are waiting in the waiting list and do not receive treatment during the time of intervention. but after treatment, they will receive acceptance and commitment treatment for maintaining the ethics of the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
Samad Khoramnia
Street address
Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
khoramniya.samad369@gmail.vom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
farid_n32@yahoo.com
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
Samad Khoramnia
Position
MSc
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
khoramniya.samad@369.gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Samad Khoramnia
Position
MSc
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
khoramniya.samad.369@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nasrin Jaber Ghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
n_jaberghaderi@yahoo.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