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Studying of supportive psychotherapy effect on COVID-19 hospitalized patients with depression and anxiety disorders in Karaj Imam Ali hospital

Protocol summary

Study aim
Comparison of the effect of drug intervention alone and drug intervention with supportive psychotherapy on the bed in patients admitted with COVID-19 and suffering from depression or anxiety disorders.
Design
Clinical trial with control group, with parallel, randomized groups, on 102 patients. Block randomization method will be used.
Settings and conduct
The center where this research is done is Imam Ali Hospital in Karaj. The sample population will be divided into 2 groups. Drug intervention is performed in both groups. At the same time, in the case group, psychotherapy intervention is performed as supportive psychotherapy on the patient's bed. Supportive psychotherapy will be such that 3 sessions during the first week and 3 sessions during the second week, interview with the patient will be done and then 1 month after discharge, the patient is re-evaluated by Beck test. The patient's next follow-up will be 3 months after discharge.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients over 18 years and under 65 years, with SARS-CoV-2 infection, which has been confirmed by PCR test, Have the required score according to the Beck Depression and Anxiety Test ,Have a GCS above 14؛ Have O2 saturation above 90%, Have proper cooperation, Willingness to participate in the study. Exclusion criteria: Failure to confirm COVID-19 on PCR ,Serious neurological disease or delirium and decreased LOC, Reluctance to participate in research, History of previous untreated psychiatric illness.
Intervention groups
Hospitalized patients with COVID-19 who, according to the Beck Depression and Anxiety Inventory, have 1 or both of these diseases and are divided into 2 groups, 1 group will receive only medication and the other group, in addition to drug intervention, They will receive supportive psychotherapy intervention.
Main outcome variables
Beck anxiety and depression score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220115053714N1
Registration date: 2022-01-26, 1400/11/06
Registration timing: prospective

Last update: 2022-01-26, 1400/11/06
Update count: 0
Registration date
2022-01-26, 1400/11/06
Registrant information
Name
Bahar Mozaffari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 903 955 4707
Email address
baharmozaffari5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-05-04, 1401/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying of supportive psychotherapy effect on COVID-19 hospitalized patients with depression and anxiety disorders in Karaj Imam Ali hospital
Public title
Studying of supportive psychotherapy effect on COVID-19 hospitalized patients with depression and anxiety disorders in Karaj Imam Ali hospital
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years old and younger than 65 years old. Infected by SARS-CoV-2 with a positive PCR test. Earning enough score of Beck depression and Beck anxiety test. GCS score more than 14 O2 saturation more than 90 percent Patients should be cooperative. willing of the patient to enter the study.
Exclusion criteria:
People without confirmed SARS-CoV-2 PCR test Having a serious neurologic disease or delirium and loss of consciousness. Patients who doesn't want to enter the study. Having a history of a serious uncontrol psychological condition.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be in blocked randomization and each group will get 2 blocks.
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 Alborz University of Medical Sciences
Street address
Alborz university of medical sciences, West Buali Ave., Nabovvat Blvd., Karaj, Iran.
City
Karaj
Province
Alborz
Postal code
1111111111
Approval date
2022-01-01, 1400/10/11
Ethics committee reference number
IR.ABZUMS.REC.1400.277

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

2

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

Primary outcomes

1

Description
Depression Beck test score
Timepoint
At the beginning of the study, one month after discharge and three months after discharge
Method of measurement
Beck depression questionnaire - Beck anxiety questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The sample population will be divided into two groups and both groups are suffering from depression and anxiety. Drug intervention will be performed in both groups. At the same time, in the intervention group, psychotherapy intervention is performed as supportive psychotherapy on the patient's bedside and his education. Supportive psychotherapy by a two-member team of psychotherapists and psychotherapists will be such that three sessions during the first week and three sessions during the second week, visits and interviews with the patient and then one month after discharge, the patient by phone to The clinic is invited and re-evaluated by a test back. The patient's next follow-up will be three months after discharge, and for the third time, an evaluation will be performed at this visit.
Category
Rehabilitation

2

Description
Control group: They will only receive medication. The drug used is citalopram from the SSRI family, which is effective in both depression and anxiety.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Ali hospital
Full name of responsible person
Dr. Atefeh Zandifar
Street address
Emam Ali hospital, Valieasr Blvd., Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3154686695
Phone
+98 26 3256 2358
Email
emamali@abzums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Hatam Goodini
Street address
Deputy of Research and Technology, Saffarian Alley, Golshahr Blvd., Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Dr. Atefeh Zandifar
Position
ََAssistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Hossein Hospital, Mansour Bakht St., Imam Khomeini Blvd., Mohammadshahr, Karaj, Iran.
City
Karaj
Province
Alborz
Postal code
31876 59348
Phone
+98 26 3419 3133
Email
zandifaratefe@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Dr. Atefe Zandifar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Hossein Hospital, Mansour Bakht St., Imam Khomeini Blvd., Mohammadshahr, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
31876 59348
Phone
+98 26 3419 3133
Email
zandifaratefe@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Bahar Mozaffari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Medical sciences University dormitory, Art university of Karaj , Nabovat Blvd, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
1111111111
Phone
+98 26 3256 2961
Email
baharmozaffari5@gmail.com

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 more 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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