Screening of psychiatric disorders in patients with Covid 19 and Psychological intervention in mental health of the patients in comparison with control group in Imam Hossein hospital
To investigate the effectiveness of telephone‐delivered treatment for psychological disorders of COVID-19 survivors in Tehran, the capital of Iran.
Design
Non-randomized- non blinded clinical trial of telephone‐delivered psychological intervention, with control group, (parallel group on 91 patients who are diagnosed as having psychological issues after primary screening)
Settings and conduct
The refereed patients to Imam Hossein hospital who are diagnosed with psychological problems are divided in two groups. Before and after the intervention the outcome variables are assessed.
Participants/Inclusion and exclusion criteria
Screening part: COVID-19 survivors who will refer to a Imam Hossein hospital in Tehran.
Intervention part: Those who are diagnosed as having psychological issues will participate in this part. Those who want to recieve psychological intervention will belong to case group and those who doesn't will be in control group.
Intervention groups
In intervention group telephone base intervention perform for 2 to 5 sessions( one to two sessions per week) and if the patient need more intervention refers to out patients clinic. In control group: the patients don't recieve telephone base interventions but they will refere to outpatient clinic if they want.
Main outcome variables
We are measuring the mental health pre and post intervention with using the GHQ questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210930052638N1
Registration date:2021-10-12, 1400/07/20
Registration timing:prospective
Last update:2021-10-12, 1400/07/20
Update count:0
Registration date
2021-10-12, 1400/07/20
Registrant information
Name
Roya Roya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 1023
Email address
roya832003@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Screening of psychiatric disorders in patients with Covid 19 and Psychological intervention in mental health of the patients in comparison with control group in Imam Hossein hospital
Public title
The effectiveness of telephone based psychological services to COVID-19 survivors in Tehran, Iran
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
In screening part:COVID-19 survivors who were referred to a referral teaching hospital
In intervention part: case group : patients suffering from psychological issues and want to recieve psychological intervention and in control group patients suffering from psychological issues and don't want to receive psychological intervention
Exclusion criteria:
Those who refuses mental health screening
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
91
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Shahid Beheshti University of Medical Sciences
Street address
Madani Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.352
Health conditions studied
1
Description of health condition studied
Depression, anxiety, post traumatic stress disorder
ICD-10 code
Z64
ICD-10 code description
Problems related to certain psychosocial circumstances
Primary outcomes
1
Description
The mental health scored assessed by GHQ
Timepoint
Before intervention and at the end of intervention
Method of measurement
Those with psychological problems (in both case and control groups) the General Health Questionnaire(GHQ) fill out and compares the score changes
Secondary outcomes
1
Description
The score of satisfaction from telephone follow up measuring by a researcher design questionnaire
Timepoint
At the end of the study
Method of measurement
At the end of the study the satisfaction from telephone follow up measure by using researcher design a Likert questionnaire
Intervention groups
1
Description
Intervention group: They receive telephone psychological intervention such as (Behavioral activation, problem solving, thought control, stress management and other related techniques) one or two times per week for 20 to 30 minutes. Psychiatrics services are available to all patients who have a psychiatric disorder
Category
N/A
2
Description
Control group: The patients who have the psychological problem and don't want to participate in telephone psychological intervention. They receive a brief psychoeducation and they can use psychiatric services if they want. They are told that their metal health status will be assess at the end of the study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Medical center,Tehran ,Iran
Full name of responsible person
Roya Vaziri Harami
Street address
Imam Hussein Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Email
roya832003@yahoo.com
Web page address
https://www.ehmc.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Vaziri Harami
Street address
Imam Hossein Medical center,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Email
roya832003@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Vaziri Harami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Hossein Medical center,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Email
roya832003@yahoo.coom
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Vaziri Harami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Hossein Medical center,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7755 1023
Email
roya832003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Vaziri Harami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Imam Hossein Medical center,Tehran ,Iran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
009821771023
Email
roya832003@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
In case of IPD briefly describe what specific participant data sets are to be shared (e.g., all collected deidentified IPD, IPD collected for the primary outcome measure only, etc)
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
This only available for people working in academic institutions
Under which criteria data/document could be used
To use for scientific and therapeutic purposes
From where data/document is obtainable
Imam Hossein Medical center, Tehran ,Iran- Rooya Vaziri-roya832003@yahoo.com
What processes are involved for a request to access data/document
All the applicants can mail through the hospital address or email address with subject to the aim of their request will access to the data or documents within three days