Protocol summary

Study aim
Evaluation of the effectiveness of resilience-based online cognitive-behavioral group intervention in reducing the symptoms of coronavirus anxiety and increase psychological well-being
Design
Intervention without control group is performed on 20 students with coronary anxiety disorder.
Settings and conduct
The group intervention was done through virtual and online classes and the counseling center of Payame Noor University of Bushehr. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being a student; with coronavirus anxiety؛ age between 18 and 40 years؛ being female. Non-inclusion criteria: having a mental illness; Taking psychiatric drugs
Intervention groups
The intervention group includes female students with coronavirus anxiety. Cognitive-behavioral therapy of coronary anxiety and Henderson resilience treatment principles are performed for 10 two-hour sessions using virtual classes (LMS) of Payame Noor University of Bushehr.
Main outcome variables
Coronary anxiety; Psychological well-being

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201007048960N2
Registration date: 2021-02-13, 1399/11/25
Registration timing: registered_while_recruiting

Last update: 2021-02-13, 1399/11/25
Update count: 0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
khatoon pourmaveddat
Name of organization / entity
Payam Noor university
Country
Iran (Islamic Republic of)
Phone
+98 77 3482 3938
Email address
khmaveddat@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-03, 1399/11/15
Expected recruitment end date
2021-02-28, 1399/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of virtual Cognitive-behavioral therapy based on resilience on reducing Corona disease anxiety and increasing psychological well-being in university students
Public title
Cognitive-behavioral therapy of Corona Disease anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Before entering the study, be concerned about Corona and contact the University Counseling Center Be a student of Payame Noor University of Bushehr Based on the cut-off point of the Corona Anxiety Questionnaire, there is a possibility of corona anxiety in them Be female Be between 18 and 40 years old
Exclusion criteria:
Having severe mental disorders other than coronary anxiety Taking psychiatric medication or using psychiatric treatments in the last 6 months
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Group therapy based on web and lms software or Adobe Connect Payame Noor University

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Payame Noor University
Street address
Payame Noor University, Ghadir street, Ashouri street
City
Bushehr
Province
Boushehr
Postal code
1688
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.PNU.REC.1399.110

Health conditions studied

1

Description of health condition studied
Corona Disease anxiety
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Corona Disease anxiety questionnaire scores
Timepoint
At the beginning, at the end of and 4 weeks after the intervention
Method of measurement
Corona Disease Anxiety Scale (CDAS)

Secondary outcomes

1

Description
Psychological well-being
Timepoint
Before the intervention, at the end of and 4 weeks after the intervention
Method of measurement
Ryff’s scale of Psychological well-being, short form (18-item)

Intervention groups

1

Description
Intervention group: Principles of cognitive behavioral therapy for anxiety with an emphasis on coronavirus care training and the Henderson resilience protocol were included in the intervention sessions in order to reduce coronavirus-caused anxiety and increase the psychological well-being of participants. The intervention will be performed in 10-12 sessions (one or two sessions per week). The coronavirus-caused anxiety and well-being of participants will be measured before and two months after the intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Payame Noor University Counseling Center Telephone counseling
Full name of responsible person
khatoon Pourmaveddat
Street address
Payame Noor University; Ashouri street
City
Bushehr
Province
Boushehr
Postal code
1656983911
Phone
+98 77 3354 3201
Email
khmaveddat@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bushehr Payame Noor University
Full name of responsible person
Mehdi Namdar Zadegan
Street address
Payame Noor University; Ashouri street
City
Bushehr
Province
Boushehr
Postal code
1656983911
Phone
+98 77 1354 3202
Email
mehdi_namdar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bushehr Payame Noor University
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
Bushehr Payame Noor University
Full name of responsible person
khatoon pourmaveddat
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ashouri St. Payame Noor University
City
Bushehr
Province
Boushehr
Postal code
69768-75168
Phone
+98 77 1354 3202
Email
khmaveddat@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Payam Noor university
Full name of responsible person
Khatoon Pourmaveddat
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Bushehr Payame Noor University; Ghadir street; Ashouri street
City
Bushehr
Province
Boushehr
Postal code
1656983911
Phone
+98 77 3355 9489
Email
khmaveddat@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bushehr Payame Noor University
Full name of responsible person
khatoon pourmaveddat
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Bushehr Payame Noor University; Ghadir street; Ashouri street
City
Bushehr
Province
Boushehr
Postal code
1656983911
Phone
+98 77 3355 9489
Email
khmaveddat@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after making individuals unidentifiable
When the data will become available and for how long
After completing the research
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
For research
From where data/document is obtainable
Researcher email address
What processes are involved for a request to access data/document
Researcher email address
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