Protocol summary

Summary
Abstract: The purpose of this study is to compare the effectiveness of cognitive- behavioral group therapy and exposure therapy on reduction of interpretation bias and fear of negative evaluation in social anxiety disorder. Twenty four students studying at B.S. level in health school of Iran university of medical sciences with diagnosis of social anxiety disorder were allocated to three 8- subject groups (cognitive- behavioral group therapy, exposure therapy, and waiting list control group) in a complete randomly method. Twelve sessions of standard cognitive- behavioral group therapy and exposure therapy were carried out, and waiting list control group didn’t receive any kind of treatment. Data were gathered through administration of Social Phobia Inventory (SPIN), Interpretation Questionnaire- Revised, and Brief Fear of Negative Evaluation Scale (BFNE-S), and analyzed statistically with covariance. Findings indicated that cognitive- behavioral group therapy comparing to exposure therapy (P= 0.01) and waiting list control group (P= 0.001) significantly led to reduction of interpretation bias in socially anxious subjects. As well as it was found that exposure therapy alone didn’t significantly reduce interpretation bias in social anxiety disorder, and do not differ from no treatment in waiting list control group (P=0.07). On the other hand, findings indicated that both cognitive- behavioral group therapy and exposure therapy in comparison with waiting list control group significantly reduced fear of negative evaluation (P= 0.001 & P= 0.002), but they do not differ significantly from each other (P= 0.25).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138806042372N1
Registration date: 2010-04-17, 1389/01/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-04-17, 1389/01/28
Registrant information
Name
Hossein Dadashzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1380 4486
Email address
dadashzadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
none
Expected recruitment start date
2007-12-22, 1386/10/01
Expected recruitment end date
2008-04-26, 1387/02/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of cognitive - behavioral group therapy and exposure therapy on interpretation bias and fear of negative evaluation in social anxiety disorder
Public title
Effectiveness of cognitive - behavioral group therapy and exposure therapy on interpretation bias and fear of negative evaluation in social anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- Diagnosis of social anxiety disorder 2- Age group: 18-40 Exclusion criteria: 1-Substance abuse 2- Depression score in BDI-2 above 30 3- Major Personality disorder 4- Diagnosis of a psychotic disorder
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
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 Menthal Health Center ,Tehran Psychiatric Institute
Street address
Niayesh St.- Sattarkhan Ave.- Tehran, Iran
City
Tehran
Postal code
14565-441
Approval date
2010-12-01, 1389/09/10
Ethics committee reference number
23/22/10/88

Health conditions studied

1

Description of health condition studied
Social anxiety disorder +Interpretation bias + Fear of negative evaluation
ICD-10 code
F40.1
ICD-10 code description
Social phobias

Primary outcomes

1

Description
Decreas of interpretation bias and Decreas of Fear of negative evaluation in social anxiety disorder.
Timepoint
1 week before intervention and 3 month after begining of intervention.
Method of measurement
Using Questionnaire of Interpretation Bias and Brief Fear of Negative Evaluation Scale (BFNE-S)

Secondary outcomes

1

Description
none
Timepoint
none
Method of measurement
none

Intervention groups

1

Description
Accomplishment of 12 sessions of standard cognitive- behavioral therapy.
Category
N/A

2

Description
Accomplishment of 12 sessions of standard exposure therapy alone.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health school - Iran university of medical sciences
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
none.
Full name of responsible person
Dr. Hossein Dadashzadeh
Street address
Razi hospital,Sahid Bakeri (Elgoli) Avenue, Tabriz, Iran.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
none.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hossein Dadashzadeh
Position
Ph.D. in Clinical Psychology and Assistant professor of clinical psychology
Other areas of specialty/work
Street address
Department of Psychiatry- Razi hospital- Sahid Bakeri (Elgoli) Avenue, Tabriz, Iran
City
Tabriz
Postal code
1567846184
Phone
+98 41 1380 4486
Fax
+98 41 1380 3351
Email
dadashzadeh@tbzmed.ac.irh_dadashzad@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hossein Dadashzadeh
Position
Ph.D. & Assistant professor of clinical psychology
Other areas of specialty/work
Street address
Department of Psychiatry, Razi hospital, Sahid Bakeri (Elgoli) Avenue, Tabriz, Iran.
City
Tabriz
Postal code
Phone
+98 41 1380 4486
Fax
Email
dadashzadeh@tbzmed.ac.irh_dadashzad@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hossein Dadashzadeh
Position
Ph.D. & Assistant professor of clinical psychology
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
dadashzadeh@tbzmed.ac.irh_dadashzad@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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