Comparison of the effectiveness of pharmacotherapy with sertraline versus Glaser reality therapy in social anxiety disorder in medical sciences students
Comparison of the effectiveness of sertraline, glassser reality therapy alone or simultaneously on social anxiety
Design
This study is a quasi-experimental study with pre-test and post-test design. First, 75 students with social anxiety will be selected by convenience sampling method and then will be randomly divided into three groups.
Settings and conduct
It will be performed on medical students with social anxiety in 1400.
Participants/Inclusion and exclusion criteria
Criteria for entering the sample into the research:
Earn the required score in the social anxiety test and diagnose social anxiety
Interest in participating in training sessions
Failure to participate in concurrent research
Criteria for excluding samples from research:
Absence for more than two sessions
Sickness
Reluctance to continue participating in research
taking medication
Addiction
The patient is undergoing other non-drug treatment
Intervention groups
In the present study, patients will be divided into three groups. Group 1: Glasser reality therapy II: Glasser reality therapy and sertraline drug Group 3: Sertraline drug therapy
Main outcome variables
social anxiety score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191106045356N4
Registration date:2021-04-21, 1400/02/01
Registration timing:prospective
Last update:2021-04-21, 1400/02/01
Update count:0
Registration date
2021-04-21, 1400/02/01
Registrant information
Name
Mohsen Zabihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3865
Email address
mzabihi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of pharmacotherapy with sertraline versus Glaser reality therapy in social anxiety disorder in medical sciences students
Public title
Comparison of the effectiveness of pharmacotherapy with sertraline versus Glaser reality therapy in social anxiety disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Earn the required score in the social anxiety test and diagnose social anxiety
Exclusion criteria:
Absence for more than two sessions
Addiction
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the samples in each group, the subjects are divided into three groups A, B and C using the RAN() function of Excel software, and according to the type of intervention, drug use and participation in mental training classes. It is a treatment, there is no possibility of blindness, there is no intervener and the subjects, and only the statistical analyst does not know what kind of intervention was done by each group.
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
thics committee of ُ Shahid Sadoughi University of Medical Sciences
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.168
Health conditions studied
1
Description of health condition studied
Social anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Social anxiety score
Timepoint
Before and after treatment
Method of measurement
standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Venlafaxine treatment will receive sertraline (50 mg daily) for 28 days, after which they will answer the questionnaire questions. In order to evaluate the effect of time on maintaining the effect of the intervention, after two months, the subjects will be asked to answer the research questionnaires again. Finally, the data will be statistically analyzed using spss24 software and multivariate analysis of covariance.
Category
Treatment - Drugs
2
Description
Intervention group: Participate in Glasser reality therapy classes in 8 sessions of 1.5 hours and two sessions per week. At the end of the sessions, all groups will answer the questions of the relevant questionnaire. In order to evaluate the effect of time on maintaining the effect of the intervention, again after two months from the last session, the subjects will be asked to answer the research questionnaires again. Finally, the data will be statistically analyzed using SPSS24 software and multivariate analysis of covariance. Summary of Glasser reality therapy therapy sessions are: introduction and introduction, introduction and purpose of the group and the number of sessions, introduction of members to each other and expressing their expectations of each other, expression of group rules. Completing the pre-test, presenting the homework, reviewing the homework of the previous session, teaching 5 basic needs from Glasser's point of view and the concept of responsibility and selection, categorizing 5 demands related to the homework of the previous week in these 5 categories by members, submitting homework, reviewing homework of the previous session, Behavior machine training and the effect of thoughts and actions on emotions and bodily changes in the form of behavior machine using members' views, examining social anxiety and examining emotions and bodily changes when social anxiety occurs, presenting homework, reviewing the previous session, teaching the desirable world And the role of desires in creating the desired world and its difference with behavior and basic needs, examining the costs of social anxiety and its importance in life and consulting members about ways to improve it using reality therapy, homework presentation, homework review of the previous session , Give a text to members to present in the meeting and receive feedback, repeat the exercise and review, present the assignment, review the assignment of the previous session, give a long text that requires group cooperation to members to present in the meeting as a group and receive feedback Repeat the exercise and review, present the homework, review the homework of the last session. Investigating the role of excuses in achieving goals. Teaching Seven Destructive Behaviors and Seven Effective Behaviors to Satisfy Needs. Introduction to preparing members for the final session, presenting assignments, reviewing previous session assignments, summarizing, receiving feedback from group members on all sessions, and results in their lives. Final, post-test tagging
Category
Behavior
3
Description
Intervention group: Venlafaxine treatment and Glasser reality therapy will use both types of interventions simultaneously and, like the other two interventions, a questionnaire will be used to evaluate them.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Univesity of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Mirzaie
Street address
Bahonar sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Mohsen Zabihi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Alem sq.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3820 3419
Email
mzabihi100@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available