Comparing the effectiveness of online Balint group and pharmacotherapy with Selective Serotonin Reuptake Inhibitors in Coronavirus anxiety in healthcare workers.
Comparing the effectiveness of online Balint group and pharmacotherapy with Selective Serotonin Reuptake Inhibitors in Coronavirus anxiety in healthcare workers
Design
This non-inferiority trial has two randomized not-blinded parallel intervention groups (target intervention Vs standard treatment). Randomization will be done in alternate allocation method according to the order of enrollment. The calculated study population is 30 (fifteen in each arm). Data will be analyzed per-protocol.
Settings and conduct
The research team will be centered in 5th Azar Hospital, Gorgan, Iran. Visits will be done by two psychiatrists through phone calls. Balint groups will be managed by a certified leader and co-leader in the Skype application.
Participants/Inclusion and exclusion criteria
All the healthcare workers in hospitals aging 18 to 59 who have been in contact with COVID-19 patients and suffering from Coronavirus anxiety. These subjects should be able to participate in online Balint sessions or use SSRIs according to the study protocol. They should not have a history of previous psychiatric illness.
Intervention groups
After being visited by two psychiatrists through phone-calls and recruiting, subjects will fill in the study questionnaires including demographics, Corona Disease Anxiety Score, and Connor-Davidson Resilience Score. Then they will be randomly allocated to the intervention groups including Balint or pharmacotherapy. Balint groups will be held online in Skype application for 8 to 10 sixty-minute sessions and the pharmacotherapy group will receive oral Sertraline tablets (starting with 50 mg/day and increased if needed according to the patient's symptoms and tolerance). Following the 4-week intervention period, subjects will again answer the questionnaires.
Main outcome variables
Corona Disease Anxiety Score (CDAS) and Connor-Davidson and Resilience Score (CD-RISC)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200411047023N1
Registration date:2021-01-26, 1399/11/07
Registration timing:retrospective
Last update:2021-01-26, 1399/11/07
Update count:0
Registration date
2021-01-26, 1399/11/07
Registrant information
Name
Hossein Mohaddes Ardabili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3700 2202
Email address
myhhoo@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
2020-06-09, 1399/03/20
Actual recruitment end date
2020-08-20, 1399/05/30
Trial completion date
2020-09-18, 1399/06/28
Scientific title
Comparing the effectiveness of online Balint group and pharmacotherapy with Selective Serotonin Reuptake Inhibitors in Coronavirus anxiety in healthcare workers.
Public title
Comparing the effectiveness of online Balint group and SSRIs in Coronavirus anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospital Healthcare workers who have been in contact with COVID-19 patients
No history of previous psychiatric illness
Ability to use Skype application and participate in online sessions
Written consent for participating in the study
Diagnosis of illness anxiety after being evaluated by two psychiatrists
Exclusion criteria:
No further interest in continuing the study
More than 3 absent Balint sessions
No medication compliance
Age
From 18 years old to 59 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects will be allocated according to the order of enrollment. The first patient to fulfill the inclusion criteria will be assigned to the Balint group, the second patient to the pharmacotherapy group, and the allocation will be continued in this way.
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 Golestan University of Medical Sciences
Street address
Ethics Committee office, Deputy of research and technology of Golestan University of Medical Sciences, Central Library building, beginning of Shast-Kala road
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2020-04-18, 1399/01/30
Ethics committee reference number
IR.GOUMS.REC.1399.020
Health conditions studied
1
Description of health condition studied
Illness anxiety disorder
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
score in Corona Disease Anxiety Scale (CDAS)
Timepoint
At the beginning of study (before intervention) and after 4 weeks
Method of measurement
Corona Disease Anxiety Scale (CDAS)
Secondary outcomes
1
Description
Score in Connor-Davidson resilience scale
Timepoint
At the beginning of study (before intervention) and after 4 weeks
Method of measurement
Connor-Davidson resilience scale
Intervention groups
1
Description
First Intervention group: Participating in 5 to 10 session of Online Balint Group
Category
Behavior
2
Description
Second Intervention group: Standard pharmacological treatment with a drug from Selective Serotonin Reuptake Inhibitors (SSRIs) started from low-dose and increased if needed during follow-up
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
5th Azar Hospital
Full name of responsible person
Najmeh Shahini
Street address
5th Azar Hospital, 5th Azar St.
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3115 3365
Email
Najmeh.shahini@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Honarvar
Street address
Deputy of research and technology of Golestan University of Medical Sciences, Central Library building, beginning of Shast-Kala road
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1654
Fax
Email
mrhonarvar@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Najmeh Shahini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
5th Azar Hospital, 5th Azar St.
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3115 3365
Email
Najmeh.shahini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Najmeh Shahini
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
5th Azar Hospital, 5th Azar St.
City
Gorgan
Province
Golestan
Postal code
4917763681
Phone
+98 17 3115 3365
Email
Najmeh.shahini@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Mohaddes Ardabili
Position
Psychiatric Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibne Sina psychiatric hospital, Horre Ameli street, BouAli square
City
Mashhad
Province
Razavi Khorasan
Postal code
9195983134
Phone
+98 51 3700 2202
Fax
Email
Myhhoo@gmail.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
After issuing appropriate permission from Golestan University of Medical Sciences all recorded data can be shared anonymously.
When the data will become available and for how long
6 months after publishing the results of the study in research journals.
To whom data/document is available
All the researchers and scientific institutes can access our data.
Under which criteria data/document could be used
All the researchers and scientific institutes should mention why and how they want to use the data in their request. Moreover, distributing further results needs new permission from the corresponding person.
From where data/document is obtainable
Written formal requests should be emailed to Dr. Najmeh Shahini using the below email address:
Najmeh.shahini@gmail.com
5th Azar Hospital, 5th Azar St., Gorgan, Iran
Phone Number: 00981731153365
What processes are involved for a request to access data/document
After receiving formal data access requests, it should be evaluated and approved by the research team and deputy of research at Golestan University of Medical Sciences.