The Effectiveness of Paroxetine on Anxiety, Depression, Fear of Negative Evaluation and Improvement of Quality of Life in Patients with Social Anxiety Disorder
The present study aimed to evaluate the efficacy of paroxetine on clinical symptoms of social anxiety, depression, fear of negative evaluation and quality of life in patients with social anxiety disorder.
Design
The Research Design includes pre-test, post-test and follow-up with the Experimental and Control Group
Settings and conduct
The statistical population of this study included all referrers to psychiatric services and private psychiatric clinics with the diagnosis of social anxiety disorder in the city of Mashhad. Twenty-four of these patients were selected in a targeted and accessible manner and randomly assigned to groups Were ranked.
Participants/Inclusion and exclusion criteria
Participants: Patients with social anxiety disorder aged 18 to 20 years and minimum degree of diploma.
entrance: En Social anxiety disorder based on diagnostic interview ( DSM-V )
Residence in Mashhad at the time of meeting group therapy
Degree higher than diploma
age between 18 to 40 years old
Exit: Having a specific axis of disorder by using a structured interview for DSM-V mental disorders Having a disabling physical illness that,it is possibile to make problem for group research Being under the psychological or Medical treatment at the same time as research
Intervention groups
The Drug Treatment Group with Paroxetine
Main outcome variables
Social anxiety; depression; fear of negative evaluation; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171228038109N4
Registration date:2019-02-09, 1397/11/20
Registration timing:retrospective
Last update:2019-02-09, 1397/11/20
Update count:0
Registration date
2019-02-09, 1397/11/20
Registrant information
Name
Mahdi Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3869 1438
Email address
amirime@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-29, 1396/11/09
Expected recruitment end date
2018-02-28, 1396/12/09
Actual recruitment start date
2018-05-10, 1397/02/20
Actual recruitment end date
2018-06-10, 1397/03/20
Trial completion date
empty
Scientific title
The Effectiveness of Paroxetine on Anxiety, Depression, Fear of Negative Evaluation and Improvement of Quality of Life in Patients with Social Anxiety Disorder
Public title
The Effectiveness of Paroxetine on Social Anxiety Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Social anxiety disorder based on diagnostic interview ( DSM-V )
Residence in Mashhad at the time of meeting group therapy
Degree higher than diploma
age between 18 to 40 years old
Exclusion criteria:
Having a specific axis of disorder by using a structured interview for DSM-V mental disorders
Having a disabling physical illness that,it is possibile to make problem for group research
Being under the psychological or Medical treatment at the same time as research
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
24
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were selected in a targeted Manner with a Diagnostic Interview according to DSM-V Criteria and Spin Anxiety Questionnaire Score and randomly selected by two-way Blind Lottery in Groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Participants and the Researcher did not know the Division of the Members into the Groups and the Participants were assigned to Groups.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Thics Committee of Mashhad University of Medical Sciences
Street address
Ebnesina Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9319797139
Approval date
2018-04-09, 1397/01/20
Ethics committee reference number
IR.MUMS.fm.REC.1396.489
Health conditions studied
1
Description of health condition studied
Social Anxiety Disorder
ICD-10 code
F93.2
ICD-10 code description
Social anxiety disorder of childhood
Primary outcomes
1
Description
Social Anxiety Scale with Spin Questionnaire
Timepoint
Pre-test, post-test, follow-up
Method of measurement
Spin Social Anxiety Scale (2000)
2
Description
Depression Scale with Beck Questionnaire
Timepoint
Pre-test, post-test, follow-up
Method of measurement
Beck Depression Inventory
3
Description
Fear of Negative Assessment with Wilson & Rappi's Consequences of Social Incidents (2005)
Timepoint
Pre-test, post-test, follow-up
Method of measurement
Wilson & Rappi's Consequences of Social Incidents (2005)
4
Description
Quality of Life Score with the World Health Organization Short Life Style Quality Scale (1989)
Timepoint
Pre-test - Post-test - Follow up
Method of measurement
World Health Organization Quality of Life Scale (1989)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the pre-test, only the experimental group under the supervision of the psychiatrist received the seven paroxetine packs each week, which were related to the therapist until the end of the study, and the control group was not subjected to any treatment intervention, and the dependent variables were examined.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Adora Specialist Consulting and Psychotherapy Center, Mashhad
Full name of responsible person
Dr. Farnaz Abhar Zanjani
Street address
No. 111, between Janbaz Ave and Samaneh Ave; Ferdowsi Boulevard
City
MASHHAD
Province
Razavi Khorasan
Postal code
0938131877
Phone
+98 51 3766 6805
Email
Farnaz.zanjani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Saeed Eslami
Street address
University of Medical Sciences, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
0938131877
Phone
+98 51 3700 2317
Email
amiri.psy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mahdi Amiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ebnesina Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
0938131877
Phone
+98 51 3700 2317
Email
amiri.psy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Elham Taheri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ebnesina Haspital
City
Mashhad
Province
Razavi Khorasan
Postal code
0938131877
Phone
+98 51 3700 2317
Email
elhamtaheri85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Farnaz Abharzanjani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Mashhad University
City
Mashhad
Province
Razavi Khorasan
Postal code
9188986586
Phone
+98 51 3869 1438
Email
farnaz.zanjani@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