The effect of cognitive-behavioral intervention in reducing fear of COVID-19 symptoms, anxiety, depression, stress and improving the quality of life in people suffering from prolonged grief disorder due to the COVID-19
The effect of cognitive-behavioral intervention in reducing fear of COVID-19 symptoms, anxiety ,depression ,stress and improving the quality of life in people suffering from prolonged grief disorder due to the COVID-19
Design
This study is a randomized controlled trial with a parallel and double-blind design, conducted on 60 patients who have tested positive for COVID-19 and have been diagnosed with prolonged grief, in two hospitals in Tehran.
Settings and conduct
The samples of this study were collected from two hospitals in Tehran (Imam Khomeini Hospital and Ziaian Hospital). Face-to-face cognitive-behavioral intervention sessions will be held by a mental health specialist in a suitable environment while fully observing health protocols.
Participants/Inclusion and exclusion criteria
1. Being within the age range of 18 to 65 years old
2. Diagnosis of COVID-19 and the individual being in the recovery phase after treatment and experiencing long-term grief
3. Willingness to participate in the program and obtaining informed consent
Intervention groups
The participants in this research include an intervention group and a control group, with the intervention group receiving a 6-session cognitive-behavioral intervention.
Main outcome variables
The primary outcome in this study is the reduction of symptoms based on an interview, and the secondary outcomes are the reduction of fear of COVID-19, anxiety, depression, stress, and improvement in the quality of life in individuals with prolonged grief disorder caused by COVID-19.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230309057660N1
Registration date:2023-04-19, 1402/01/30
Registration timing:prospective
Last update:2023-04-19, 1402/01/30
Update count:0
Registration date
2023-04-19, 1402/01/30
Registrant information
Name
Mojgan sadat Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4608 4429
Email address
mozhi.aba97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-behavioral intervention in reducing fear of COVID-19 symptoms, anxiety, depression, stress and improving the quality of life in people suffering from prolonged grief disorder due to the COVID-19
Public title
Psychological intervention and counseling to reduce symptoms of prolonged grief disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being within the age range of 18 to 65 years old
Diagnosis of COVID-19 in an individual and the person is in the post-treatment recovery phase and also suffers from prolonged grief disorder
Willingness to participate in the project and obtaining informed consent
Exclusion criteria:
Severe physical problems or visible organ impairment
Patients with major depressive disorder, psychosis, or major psychiatric disorders were not included in the study and only initial drug treatments were performed for them
Age
From 18 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals who have admission criteria receive a specific code, and then a certain number of them are randomly selected using a table of random numbers. Then, a random selection is made to determine the two experimental and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention conditions in this study are such that blinding the participants to the type of intervention is not feasible. The outcome assessor will be responsible for questioning and will not be one of the intervention experts in the study, and the data analyst will not have information about the nature of the study groups' coding.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-04-10, 1402/01/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.033
Health conditions studied
1
Description of health condition studied
prolonged grief disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The primary outcome variable in this study is prolonged grief resulting from COVID-19
Timepoint
Assessment will be conducted in two stages, including prior to the start of cognitive-behavioral intervention, and one month after the final session of the intervention
Method of measurement
Using the Structured Clinical Interview for DSM Disorders (SCID)
Secondary outcomes
1
Description
Fear of COVID-19 Scale Score in Individuals with COVID-19-Related Prolonged Grief Disorder
Timepoint
Assessment will be conducted in two stages, including prior to the start of cognitive-behavioral intervention, and one month after the final session of the intervention
Method of measurement
Fear of COVID-19 Scale
2
Description
Depression scores in individuals with prolonged grief disorder due to COVID-19
Timepoint
Assessment will be conducted in two stages, including prior to the start of cognitive-behavioral intervention, and one month after the final session of the intervention
Method of measurement
Using the Depression-Anxiety-Stress Scale (DASS-21) questionnaire
3
Description
Quality of life score in individuals with prolonged grief disorder due to COVID-19
Timepoint
Assessment will be conducted in two stages, including prior to the start of cognitive-behavioral intervention, and one month after the final session of the intervention
Method of measurement
Using the WHOQOL-BREF questionnaire
4
Description
Anxiety scores in individuals with prolonged grief disorder due to COVID-19
Timepoint
Assessment will be conducted in two stages, including prior to the start of cognitive-behavioral intervention, and one month after the final session of the intervention
Method of measurement
Using the Depression-Anxiety-Stress Scale (DASS-21) questionnaire
5
Description
Stress scores in individuals with prolonged grief disorder due to COVID-19
Timepoint
Assessment will be conducted in two stages, including prior to the start of cognitive-behavioral intervention, and one month after the final session of the intervention
Method of measurement
Using the Depression-Anxiety-Stress Scale (DASS-21) questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: The cognitive-behavioral intervention in this study is described as follows: In the first session, the participants are greeted and the cognitive-behavioral model (A-B-C) is introduced and its relationship with the treatment of prolonged grief disorder is explained. In the second session, coping strategies for depression and anxiety and improving the quality of life in patients with prolonged grief disorder are discussed. The third session focuses on teaching logical thinking techniques. The fourth session teaches problem-solving skills. The fifth session addresses cognitive errors and coping strategies for them. The final session focuses on relapse prevention
Category
Other
2
Description
Control group: The control group received usual care during this period
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Seyed salman Alavi
Street address
Blv.keshavarz
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9004
Email
Imamhospital@tums.ac.ir
2
Recruitment center
Name of recruitment center
Ziaeian Hospital
Full name of responsible person
Seyed salman Alavi
Street address
Ziaian Educational-Medical Center" located at "Abouzar 20-meter street, at the junction of Ghazvin Street and Qapan Square, Abouzar, Tehran
City
Tehran
Province
Tehran
Postal code
1366736511
Phone
+98 21 5517 6810
Fax
+98 21 5575 1333
Email
ziaeian@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Salman Alavi
Street address
Tehran University of Medical Sciences Headquarters, Boulevard Keshavarz
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 8163 3698
Fax
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Seyed salman Alavi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ruzbeh Hospital, South Kargar St
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5541 3540
Fax
+98 21 5541 3197
Email
ssasi1979@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed salman Alavi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ruzbeh Hospital, South Kargar St
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5541 3540
Fax
+98 21 5541 3197
Email
ssasi1979@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed salman Alavi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ruzbeh Hospital, South Kargar St
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5541 3197
Fax
+98 21 5541 3197
Email
ssasi1979@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available