Determining the effectiveness of cognitive-behavioral psychotherapy based on spiritual care on reducing anxiety in patients with Covid 19
Design
This study is a clinical trial that has a control and intervention group and will be performed without blinding. The sampling method is non-random simple that the target population is patients hospitalized with Covid 19 in Imam Reza (AS) Hospital in Mashhad. The number of samples is estimated at 30% with a drop of 5%. Therefore, the statistical sample size will be 30 people.
Settings and conduct
The study site is Imam Reza AS Hospital in Mashhad and its target population is patients with Covid 19 in Imam Reza (AS) Hospital in Mashhad. In the present study, after the formation of intervention groups, psychotherapy based on spiritual care based Bussing protocol will be performed. Data collection will be done through the Hospital Anxiety and Depression Scale (HADS) questionnaire. And data analysis is done using SPSS version 21.
Participants/Inclusion and exclusion criteria
Have a minimum of trainability,Have a minimum level of awareness 10,The total duration of hospitalization is at least 14 days to evaluate the effect of the intervention,Have a minimum age of 15 and a maximum of 65 years
Being a Muslim,Absence of psychiatric illness.
Intervention groups
After selecting the sample in a purposeful way (through the hads questionnaire and patients whose medical interpretation of respiratory distress has no medical justification and is included in the file), a pre-test will be performed. Richards and Bergin will perform the intervention in five sessions to identify the spiritual challenges of individuals that reinforce the anxiety created by the trained research team. The control group will not receive any other intervention in addition to conventional drug therapies.
Main outcome variables
Anxiety and respiratory distress caused by anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210513051282N2
Registration date:2021-11-23, 1400/09/02
Registration timing:retrospective
Last update:2021-11-23, 1400/09/02
Update count:0
Registration date
2021-11-23, 1400/09/02
Registrant information
Name
seyed mahmoud tabatabaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 5777
Email address
tabanet@um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-10-07, 1400/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Psychotherapy Method Based on Spiritual Care on Reducing Anxiety and Symptoms of Respiratory Distress in Patients with COVID-19
Public title
Evaluation of the effectiveness of psychotherapy method based on spiritual care on reducing anxiety and respiratory distress syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Have a minimum level of awareness 10
Be at least 15 and at most 65 years old
The patient is physically fit
Being a Muslim
Exclusion criteria:
History of receiving psychological interventions during the last 6 months
History of receiving psychiatric medication during the last 6 months with severe psychiatric illness (psychosis, bipolar disorder and mental retardation)
Death of the patient
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Sample people will be selected randomly without substitution (lottery). In the lottery method, a number or code is prepared for each member of the community. Then the numbers are written on pieces of paper. The pieces of paper are placed in a container. It is given and mixed well, then a sample with a certain volume is selected.
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
Organizational Ethics Committee of Mashhad University of Medical Sciences
Street address
Department of Medical Ethics Committee, School of Medicine, Campus, Azadi University, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9194568899
Approval date
2021-08-28, 1400/06/06
Ethics committee reference number
IR.MUMS.REC.1400.161
Health conditions studied
1
Description of health condition studied
• Patients with Covid admitted to Imam Reza Hospital in Mashhad
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
• Anxiety
Timepoint
Before intervention, one week after intervention
Method of measurement
The Hospital Anxiety and Depression Scale (HADS) questionnaire will be administered.
Secondary outcomes
1
Description
Reduce respiratory distress from increased anxiety
Timepoint
Before intervention, one week after intervention
Method of measurement
The patient's respiratory symptoms are examined by a physician
Intervention groups
1
Description
Experimental group: Spiritual-religious care sessions based on the model (Bergin and Richards) focusing on the religion of Islam and the opinion of the religious expert of the research team in 5 sessions twice a week for 45 to 60 minutes.
Category
Behavior
2
Description
Control group: Control group: There is no spiritual care for the control group and they receive only normal and routine care in the hospital. If the results of the study were significant, in order to observe ethics, after studying, the necessary information will be provided to them by CD and pamphlet
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Fatemeh Rezaei
Street address
Ibn Sina St., Imam Reza Hospital Square, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9178787665
Phone
+98 51 3841 1536
Email
Rezaeif@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Mahmoud Tabatabaei
Street address
University Street in front of the University 18 Central Building of Mashhad University of Medical Sciences Office of the Leadership Institution
City
Mashhad
Province
Razavi Khorasan
Postal code
917786655
Phone
+98 51 3841 5777
Email
tabanet@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Rezaei
Position
therapist and psychologist resercher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Office of Leadership Institution of Mashhad University of Medical Sciences, Central Building, University Street, in front of the University 18
City
Mashhad
Province
Razavi Khorasan
Postal code
917876655
Phone
+98 51 3841 5777
Email
Rezaeif@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Mahmoud Tabatabaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Ethics
Street address
• Office of the Leadership Institution- Central Building of Mashhad University of Medical Sciences- University Street in front of the University 18- Mashhad – Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
917786655
Phone
+98 51 3841 5777
Email
tabanet@um.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Rezaei
Position
Therapist and psychologist resercher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Office of Leadership Institution, Mashhad University of Medical Sciences, Central Building, in front of University 18, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
917876655
Phone
+98 51 3841 5777
Fax
Email
rezaei@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main consequences of the data, including anxiety and respiratory distress, will be shared.
When the data will become available and for how long
The data will be available after the end of the study from September 1401.
To whom data/document is available
Data is available for researchers working in universities and scientific institutes
Will be accessible.
Under which criteria data/document could be used
The data will be provided with the permission of the University of Medical Sciences and only the use of its results for further research.
From where data/document is obtainable
- Email: Dr. Tabatabai tabanet@um.ac.ir
What processes are involved for a request to access data/document
The applicant must send a written request to the author of the article by e-mail and after contacting the author by phone, the author will provide information to the applicant by email for a maximum of 20 days after obtaining permission from Mashhad University of Medical Sciences.
The data will be provided with the permission of Mashhad University of Medical Sciences and only the use of its results for further research.