Comparison of Cognitive-Behavioral Group Therapy and training of relaxation techniques on students' anxiety
Design
The study is an interventional, prospective, and randomized study. The randomization method will be performed with the help of the Excel random number table. The completion of the three stages of the Spielberger questionnaire will be completed by 40 students. The first step is before the implementation of the training process. Then group therapy sessions will be held for one group and training for relaxation exercises will be held for the other group.
After the sessions are completed, the questionnaires will be completed simultaneously for two weeks and then three months later by both groups. And a group will also be considered as a control, which will complete the questionnaire three times without attending classes
Settings and conduct
This study will be conducted on students living in Bushehr Medical Sciences Dormitories. In this way, the Spielberger questionnaire will be provided to the students and then, according to the students' anxiety scores, the study will be done in three groups.
Participants/Inclusion and exclusion criteria
Entry Requirements:
Moderate to severe anxiety based on Spielberger questionnaire
Residence in girls' dormitory as a student of Bushehr University of Medical Sciences
The desire to participate in the study
Non-arrival conditions:
Student not being at the time of the study
Intervention groups
1- A group for whom Cognitive-Behavioral Group Therapy is taught.
2. A group for whom training is given to relaxation techniques.
3. Control group that does not receive any training.
Main outcome variables
The Effect of Group Therapy Training on Students 'Anxiety; The Effect of Teaching Relaxation Techniques on Students' Anxiety; Comparing Two Methods of Study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141102019780N2
Registration date:2018-05-07, 1397/02/17
Registration timing:retrospective
Last update:2018-05-07, 1397/02/17
Update count:0
Registration date
2018-05-07, 1397/02/17
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4436 1156
Email address
zahra_rafiee67@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-10-02, 1393/07/10
Expected recruitment end date
2014-11-01, 1393/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cognitive-behavioral group therapy and training of relaxation techniques on students' anxiety
Public title
Comparison of two methods of Cognitive-Behavioral group Therapy and relaxation techniques on reducing student anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate to severe anxiety scores based on Spielberger questionnaire
Residence in girls' dormitory as a student of Bushehr University of Medical Sciences
The desire to participate in the study
Exclusion criteria:
Student not being at the time of the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
How to randomize this research include the following steps
At first, the researcher randomly and voluntarily selected the students of the dormitory living in the dormitory in order to complete the Spielberger's anxiety questionnaire. Then, after examining the scores of each student, they would enter the study among those who had a moderate to severe anxiety score. Became In the next step, randomly and with the numbering of each questionnaire, the students will be divided into three groups. The first group, which is numbered 1 to 15, is called the first intervention group and the second group is from 15 to 30. The second intervention group and the third group, from 30 to 40, will be called the control group. Subsequently, with the help of the spss software, the information of each student related to the completion of the questionnaire at different stages of the research, according to the number assigned by the researcher to the student Finding will arrive in the software.
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 Bushehr University of Medical Sciences
Street address
bushehr. sabzabad. University of Medical Sciences
City
bushehr
Province
Boushehr
Postal code
7514633341
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
B-93-16-10
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Student anxiety
Timepoint
Before intervention / two weeks after intervention / three months after intervention
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The "first intervention group" includes 15 people attending cognitive-behavioral group therapy training sessions. The intervention is that in the course of eight sessions, regular training will be given to the group members by the psychologist.
Category
Treatment - Other
2
Description
The "second intervention group" includes 15 people attending training sessions on relaxation techniques. The intervention is that six sessions will be regularly provided by the psychologist to the members of the group
Category
Treatment - Other
3
Description
The "control group" includes 10 people who will not receive any training and will not intervene.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bushehr University of Medical Sciences
Full name of responsible person
Zahra Rafiee
Street address
University of Medical Sciences, Salman Farsi Ave. Sabz Abad, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Fax
Email
zahra_rafiee67@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Afshin Ostovar
Street address
Bushehr University of Medical Sciences, Pardis site, Rishehr St ,Bushehr
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3345 0178
Fax
Email
zahra_rafiee67@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr University of Medical Sciences
Proportion provided by this source
30
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
Boushehr University of Medical Sciences
Full name of responsible person
Zahra Rafiee
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bushehr University of Medical Sciences, Salman Farsi Ave, Sabzabad,
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
zahra_rafiee67@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Masoud Bahreini
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bushehr University of Medical Sciences, Salman Fars Ave, Sabzabad
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
msd.bahreini@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Zahra Rafiee
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Bushehr University of Medical Sciences, Salman Farsi Ave, Sabzabad,
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
zahra_rafiee67@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information that relates to student anxiety score can be shared
When the data will become available and for how long
Three months after the results are published
To whom data/document is available
All researchers have permission to receive information
Under which criteria data/document could be used
If necessary, use the data of their publication and publication, after obtaining consent from the participants in the study
From where data/document is obtainable
Email your request by email:
zahra_rafiee67@yahoo.com
What processes are involved for a request to access data/document
After sending the email and reviewing the request if it is mentioned in the terms of the terms, it will be answered by email within a maximum of one month