Protocol summary

Study aim
This study aims to compare the effectiveness of compassion therapy and eye movement desensitization and reprocessing therapy (EMDR) on coronary anxiety, uncertainty intolerance, catastrophizing and coping efficiency of patients with coronavirus (COVID-19).
Design
A clinical trial with a control group, parallel groups, one-way blind, randomized, phase 2 on 45 patients. A table of random numbers will use for randomization.
Settings and conduct
Following randomization and assignment of individuals in the study groups, patients are treated approximately twice a week using compassion therapy and eye movement desensitization and reprocessing therapy (EMDR). This study will be run at the Behin Clinic in Khoram Abad city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: History of having coronavirus, No presence of any other mental disorders, No history of mental illness, No dependence on alcohol or drugs, Do not receive other current psychological treatment. Exclusion criteria: Having suicidal thoughts and beliefs, Declining to participate in therapy sessions.
Intervention groups
compassion therapy and eye movement desensitization and reprocessing therapy
Main outcome variables
Coronary anxiety: anxiety, feeling of tension, worry, and fear about the infection of oneself or others to corona disease. Uncertainty intolerance: feeling of unwillingness to tolerate the possibility of negative events in the future; Catastrophizing: the cognitive process is to exaggerate or magnify the perceived threat of pain sensations; Coping efficiency: person's self-confidence is in performing coping behaviors when facing life's challenges and threats.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220911055938N1
Registration date: 2022-09-13, 1401/06/22
Registration timing: prospective

Last update: 2022-09-13, 1401/06/22
Update count: 0
Registration date
2022-09-13, 1401/06/22
Registrant information
Name
Nasim Beyranvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3333 3333
Email address
imnasimb@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-22, 1401/06/31
Expected recruitment end date
2022-10-11, 1401/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of compassion therapy and eye movement desensitization and reprocessing therapy (EMDR) on coronary anxiety, uncertainty intolerance, catastrophizing and coping efficiency of patients with coronavirus (COVID-19)
Public title
Comparison of the Effectiveness of compassion therapy and eye movement desensitization and reprocessing therapy (EMDR) on patients with coronavirus (COVID-19)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of having coronavirus No presence of any other mental disorders No history of mental illness No dependence on alcohol or drugs Do not receive other current psychological treatment Age between 20 - 40
Exclusion criteria:
Having suicidal thoughts and beliefs Declining to participate in therapy sessions
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will run by using the Software Allocation Random. Since the total number of samples predicted for the present study is small (n=45), we will use the simple randomization method to assign subjects to three study groups. We will assign a unique number to every member of our study's sample (from 1 to 45). An independent researcher makes random allocation codes using computer-generated random numbers. Then, we will use the random allocation generator software to randomly assign each number to experimental and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study was single blind. The data analyst and the person conducting the assessments will be blind to the specific participant’s group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University - Boroujerd Branch
Street address
Imam Khomeini University Complex, 3 km Yadgar Imam Road, Nawab Square, Borujerd
City
Boroujerd
Province
Lorestan
Postal code
6915136335
Approval date
2022-04-19, 1401/01/30
Ethics committee reference number
IR.IAU.B.REC.1401.001

Health conditions studied

1

Description of health condition studied
Coronavirus
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Coronary anxiety: the score obtained by the corona anxiety Questionnaire (Alipour et al. 2018).
Timepoint
One week before the intervention, one week after the last intervention session, two months after the last intervention session
Method of measurement
Questionnaire

2

Description
Uncertainty intolerance: the score that participles will get from the uncertainty intolerance questionnaire.
Timepoint
One week before the intervention, one week after the last intervention session, two months after the last intervention session
Method of measurement
Questionnaire

3

Description
Catastrophizing: the score participles will get from the catastrophizing subscale of the Rosenstiel and Keefe (1983) coping strategies questionnaire.
Timepoint
One week before the intervention, one week after the last intervention session, two months after the last intervention session
Method of measurement
Questionnaire

4

Description
Coping efficiency: the score participles will get from the Chesney et al.'s (2006) coping efficiency questionnaire.
Timepoint
One week before the intervention, one week after the last intervention session, two months after the last intervention session
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
compassion therapy intervention: Compassion-focused therapy consists of eight weekly 90-minute sessions conducted in a group setting. Each session will include introducing goals and topics related to that session, discussions, exercises inside the session, and exercises outside the session.
Category
Behavior

2

Description
Eye movement desensitization and reprocessing therapy (EMDR) intervention: includes ten one-hour treatment sessions, individually and two weekly, based on the standard protocol of EMDR.
Category
Behavior

3

Description
Control group: After the intervention phase of this study, control group patients can be treated by psychologists in the Behin psychology clinic.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Behin psychology clinic
Full name of responsible person
Nasim Beyranvand
Street address
Unit 5, Nourizadeh building, Amiri alley, Alavi street, Khorram Abad
City
khorram Abad
Province
Lorestan
Postal code
6813918468
Phone
+98 66 3343 2180
Email
behinclinic@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahboobeh Chinaveh
Street address
Daneshgah St.,Western Modarres Ave, Boroujerd, Iran.
City
Boroujerd
Province
Lorestan
Postal code
6915136335
Phone
+98 66 3343 2180
Email
hivachinaveh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Nasim Beyranvand
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Daneshgah St.,Western Modarres Ave, Boroujerd, Iran.
City
Boroujerd
Province
Lorestan
Postal code
6915136335
Phone
+98 66 3343 2180
Email
imnasimb@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahboobeh Chinaveh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Daneshgah St.,Western Modarres Ave, Boroujerd, Iran.
City
Boroujerd
Province
Lorestan
Postal code
6915136335
Phone
+98 66 3343 2180
Email
hivachinaveh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nasim Beyranvand
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Daneshgah St.,Western Modarres Ave, Boroujerd, Iran.
City
Boroujerd
Province
Lorestan
Postal code
6915136335
Phone
+98 66 3343 2180
Email
imnasimb@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
Data from participants' responses to coronary anxiety, uncertainty intolerance, catastrophizing and coping efficiency questionnaires in pre-test, post-test and follow up will analyze using SPSS software, and the results, without mentioning the names of the participants, were shared as study results.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
The data of this study will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The data of this study will be provided for use by researchers in review or comparative studies.
From where data/document is obtainable
Nasim Beyranvand, Department of Psychology, Islamic Azad University, Boroujerd Branch, Iran. imnasimb@gmail.com +98 991 653 6422
What processes are involved for a request to access data/document
The applicant provides information about their application via email. Up to two weeks after the request, if accepted, documents or data files will be sent.
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