30 patient with social anxiety disorder diagnosis based on accessible sampling will participate in this research. Participants will be randomly assigned into 3 groups (10 persons in attention modification group, 10 person in pharmachotherapy group and 10 person in combined attention modificationand pharmachotherapy group). In pharmachotherapy group, participants will receive standard dosage of paroxetine (20mg to 50mg daily and orally). Participants in attention modification group will complete probe-detection task. This task consists of paired words appearing on computer screen in a short time. One word is emotionally negative and is related to social threat (e.g criticism), another word is emotionally neutral and unrelated to social threat (e.g pencile). Subjects task is to diagnose probe sign when replacing with one of paired words and pressing related key on keyboard. probe sign is always replaced with neutral words, but participants are not told about that. Presenting probe sign after neutral words repeatedly results in changes in attentional bias from emotional word toward neutral word. Participants in combined group will receive both pharmachotherapy and attention modification program Subjects in all groups will answer Beck Depression Inventory(BDI-II), Beck Anxiety Inventory(BAI), Social Phobia Inventory(SPIN), General Health Questionnaire(GHQ) and Sheehan Disability Sscale(SDS) before and after intervention.
General information
Acronym
SP, SAD
IRCT registration information
IRCT registration number:IRCT201102035750N1
Registration date:2012-03-10, 1390/12/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-10, 1390/12/20
Registrant information
Name
Hosein Khedmatgozar
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1655
Email address
khedmatgozar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research of Tehran univesity of medical sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of Paroxetine, Attention Modification Program and combination of both on improving social anxiety symptoms
Public title
Treatment of social anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Not being under pharmachotherapy before research; Not receiving psychotherapy before research; Having social anxiety disorder diagnosis according DSM-IV criteria; Having informed consent; 18 to 50 years old; At least guidance level education. Exclusion criteria: Having psychotic signs and symptoms; Substance abuse; Diagnosis of comorbid axis I disorders in DSM-IV; Suicidal ideation; Axis II diagnosis in DSM-IV.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Tehran university of medical sciences
Street address
16 Azar street
City
Tehran
Postal code
Approval date
2010-07-01, 1389/04/10
Ethics committee reference number
1243/130/د/90
Health conditions studied
1
Description of health condition studied
social phobia
ICD-10 code
F40.1
ICD-10 code description
Social phobias
Primary outcomes
1
Description
social phobia
Timepoint
before and after intervention with 2 months interval
Method of measurement
Social Phobia Inventory(SPIN)
Secondary outcomes
1
Description
depression
Timepoint
before and after intervention with 2 months interval
Method of measurement
Beck Depression Inventory(BDI-II)
2
Description
anxiety
Timepoint
before and after intervention with 2 months interval
Method of measurement
Beck Anxiety Inventory(BAI)
3
Description
general health
Timepoint
before and after intervention with 2 months interval
Method of measurement
General Health Questionnaire(GHQ)
4
Description
function
Timepoint
before and after intervention with 2 months interval
Method of measurement
Sheehan Disability Scale(SDS)
Intervention groups
1
Description
Attention modification group: Participants will complete probe-detection task. This task consists of paired words appearing on computer screen in a short time. One word is emotionally negative and is related to social threat (e.g criticism), another word is emotionally neutral and unrelated to social threat (e.g. pencil). Subjects’ task is to diagnose probe sign when replacing with one of paired words and pressing related key on keyboard. Probe sign is always replaced with neutral words, but participants are not told about that. Presenting probe sign after neutral words repeatedly results in changes in attentional bias from emotional word toward neutral word.
Category
Treatment - Other
2
Description
Pharmachotherapy group: participants will receive standard dosage of paroxetine orally (20mg to 50mg, daily).
Category
Treatment - Drugs
3
Description
Combined group: Participants in combined group will receive both pharmachotherapy and attention modification program.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Lavasani hospital
Full name of responsible person
Hosein Khedmatgozar
Street address
Sorkhehesar, Tehranpars
City
Tehran
2
Recruitment center
Name of recruitment center
Hazrat Rasul Akram hospital
Full name of responsible person
Mr Kahani
Street address
Nyayesh street, Sattarkhan street
City
Tehran
3
Recruitment center
Name of recruitment center
Abureihan clinic
Full name of responsible person
Miss Taghipur
Street address
Enghelab street, Felestin street
City
Tehran
4
Recruitment center
Name of recruitment center
psychiatric clinics
Full name of responsible person
Street address
City
Tehran
5
Recruitment center
Name of recruitment center
Milad pospital, Quds clinic, Tehran psychiatric institute clinic, ...
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research of Tehran univesity of medical sciences
Full name of responsible person
Dr Akbar Fotoohi
Street address
4th floor of central organization of Tehran University of Medical Sciences, Gods street, Keshavarz blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research of Tehran univesity of medical sciences
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
Tehran university of medical sciences
Full name of responsible person
Hosein Khedmatgozar
Position
student
Other areas of specialty/work
Street address
Tehran psychiatric institute, Nyayesh street, Sattarkhan street
City
Tehran
Postal code
Phone
+98 21 6655 1655
Fax
Email
khedmatgozar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Hosein Khedmatgozar
Position
student
Other areas of specialty/work
Street address
Tehran psychiatric institute, Nyayesh street, Sattarkhan street
City
Tehran
Postal code
Phone
+98 21 6655 1655
Fax
Email
khedmatgozar@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)