Protocol summary

Study aim
Determine the effectiveness of psychological interventions on Mental health of health personnel working in hospitals and clinics of KMU During the period of the corona virus outbreak
Design
an empirical intervention based educational research, With pre-test and post-test of control and intervention groups, Simple randomization with sample size of 60 people
Settings and conduct
The present study is an empirically based educational intervention with a pretest-posttest and intervention and control group design which will be done after approval of the code of ethics by Kerman University of Medical Sciences. Then, the questionnaire link will be posted on the college website to gain statistical population. The public relations department of the University will call for the health care staff under the supervision of Kerman University of Medical Sciences to answer this questionnaire and those who are hospitalized or depressed based on their scores and would like to participate in the study. They were randomly divided into intervention and control groups and entered the study. The intervention group will be comprised of a psychological counseling program consisting of 10 daily sessions through virtual networks such as WhatsApp or Skype for 30 to 45 minutes individually. The post-test will be given to the two groups after the training sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria :Satisfaction to participate in the study, Health or medical staff at Corona Screening Reference Clinics, No Coronavirus Disease now. Exclusion criteria :Do not attend two or more counseling sessions.
Intervention groups
Intervention group: Psychological counseling program consisting of 10 daily virtual sessions through virtual networks such as WhatsApp or Skype For 30 to 45 minutes. Control group: There is no intervention.
Main outcome variables
Anxiety, depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170611034452N11
Registration date: 2020-03-31, 1399/01/12
Registration timing: registered_while_recruiting

Last update: 2020-03-31, 1399/01/12
Update count: 0
Registration date
2020-03-31, 1399/01/12
Registrant information
Name
Atefeh Ahmadi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5205
Email address
a.ahmadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-30, 1399/01/11
Expected recruitment end date
2020-04-08, 1399/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of psychological interventions on mental health of Kerman University of Medical Sciences’s mental health in hospitals and reference clinics
Public title
Investigating the effectiveness of psychological interventions on mental health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study Health or medical staff at Corona Screening Reference Clinics No Coronavirus Disease At the moment
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple
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 Kerman University of Medical Sciences and Health Services
Street address
Pardis of Kerman University, First element of the Haft Bagh Allavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-03-18, 1399/12/28
Ethics committee reference number
IR.KMU.REC.1398.737

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

2

Description of health condition studied
Coronavirus disease (COVID-19)
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Anxiety,
Timepoint
Before the intervention, immediately after the intervention
Method of measurement
Health Anxiety Assessment Questionnaire

2

Description
Depression
Timepoint
Before the intervention, immediately after the intervention
Method of measurement
Hospital Anxiety-Depression Index Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Intervention is used to Psychological counseling program consisting of 10 daily virtual sessions through virtual networks such as WhatsApp or Skype For 30 to 45 minutes
Category
Lifestyle

2

Description
Control group: There is no intervention for the control group
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman hospitals and Clinics
Full name of responsible person
Masoome Ghazanfarpur
Street address
Pardis of Kerman University, First element of the Haft Bagh Allavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
a.ahmadi@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firoozeh Mirzaee
Street address
Pardis of Kerman University, First element of the Haft Bagh Allavi, Kerman
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3226 3815
Email
kmu_research@yahoo.co
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
50
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
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
Proffessor asistant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Pardis of Kerman University, First element of the Haft Bagh Allavi, Kerman
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
a.ahmadi@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
Proffessor asistant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Pardis of Kerman University, First element of the Haft Bagh Allavi, Kerman
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
a.ahmadi@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Atefeh Ahmadi
Position
Proffessor asistant
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Pardis of Kerman University, First element of the Haft Bagh Allavi, Kerman
City
Kerman
Province
Kerman
Postal code
76169-13555
Phone
+98 34 3132 5700
Email
a.ahmadi@kmu.ac.ir

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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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