Comparing the effect of interpersonal psychotherapy and compassion focused therapy on the grief experience and quality of life in first-degree relatives of the deceased caused by Covid 19
Determining and comparing the effect of interpersonal psychotherapy and compassion focused therapy on the grief experience and quality of life in first-degree relatives of the deceased caused by Covid 19
Design
Single-blind, randomized clinical trial without a control group, with parallel groups, on 40 patients
Settings and conduct
Forty people whose first-degree relatives have died due to COVID-19 in the last 6 months and are eligible to be included and have a file in one of the Khorshid and Al-Zahra hospitals, will be selected and will enter the study if satisfied. These people are randomly divided into two groups. One group will receive interpersonal psychotherapy and the other group will receive compassion focused therapy.
Participants/Inclusion and exclusion criteria
The individuals who have experienced the death of a first-degree relative due to COVID 19 during the last six months, grief experience questionnaire (GEQ) score of >34, willing to participate in the study, aged over 18 yrs. , no major psychiatric illness (schizophrenia, bipolar), Obsession, personality disorders) and drug use disorders (based on an interview with a psychiatric assistant). Exclusion criteria include not attending treatment sessions for more than two consecutive sessions and exacerbation of symptoms and the need for psychiatric hospitalization.
Intervention groups
First intervention group: Individuals in this group will be treated as interpersonal psychotherapy in 6 sessions of 45 minutes to one hour individually with the presence of a trained clinical psychologist and an assistant psychiatrist.
Second intervention group: Individuals in this group will be treated with compassion focused therapy in 6 sessions of 45 minutes to one hour individually in the presence of a trained clinical psychologist and an assistant psychiatrist.
Main outcome variables
Grief experience score; Quality of life score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201119049445N1
Registration date:2021-02-13, 1399/11/25
Registration timing:registered_while_recruiting
Last update:2021-02-13, 1399/11/25
Update count:0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
Hajar Salimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2127
Email address
salimi85ha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2021-05-21, 1400/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of interpersonal psychotherapy and compassion focused therapy on the grief experience and quality of life in first-degree relatives of the deceased caused by Covid 19
Public title
Comparing the effect of psychotherapy on the grief experience and quality of life in first-degree relatives of the deceased caused by COVID 19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Death of a first-degree relative due to COVID19 in the last six months
Grief Experience Questionnaire (GEQ) score of >34
Being consent to participate in the study
The age of >18 yrs.
No major psychiatric illness (schizophrenia, bipolar, obsessive-compulsive disorder, personality disorders)
Drug use disorder based on an interview with a psychiatric assistant
Exclusion criteria:
Failure to attend treatment sessions for more than two consecutive sessions
Exacerbation of symptoms and the need for psychiatric hospitalization
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Forty eligible students will be randomly selected using convenience sampling. These people are then coded with the aid of Random Allocation software and are automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one person and that person will be randomly studied in one of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the different content of individual psychotherapy and compassion focused therapy sessions, the intervener is aware of the two groups, but the participant will not be aware of the difference in the type of treatment due to lack of awareness of the other group. In addition, the person collecting the information and the statistician will not be aware of the two groups before the end of the treatment period.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib street, Azadi square.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-09-20, 1399/06/30
Ethics committee reference number
IR.MUI.MED.REC.1399.519
Health conditions studied
1
Description of health condition studied
Early signs of grief based on obtaining a score of more than 34 from the grief experience questionnaire
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Grief score
Timepoint
Before and 4 weeks after the intervention
Method of measurement
Grief Experience Questionnaire
2
Description
Quality of Life
Timepoint
Before and 4 weeks after the intervention
Method of measurement
World Health Organization (WHO) Quality of Life Questionnaire - Short Form
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Individuals in this group will be treated as interpersonal psychotherapy in 6 sessions of 45 minutes to one hour individually with the presence of a trained clinical psychologist and an assistant psychiatrist. In these sessions, the person will be trained to recognize the symptoms of depression, correct relationships (including reviewing the history of the relationship with the deceased; high intimacy or guilt due to inaction and anger of the deceased); Expanding relationships with the deceased (such as examining positive relationships with the deceased during life, the ability of clients to care for the deceased) and expanding relationships with other relatives and family (including examining the quality and quantity of previous relationships with others and role play for Verbal communication, expression of feelings and self-disclosure.
Category
Treatment - Other
2
Description
Second intervention group: Individuals in this group will undergo compassion-focused therapy in 6 sessions of 45 minutes to one hour individually with the presence of a trained clinical psychologist and a psychiatrist assistant. In these sessions, the person will be trained to get familiar with the general concept of self-compassion and empathy and the practice of rhythmic calming breathing; self-critical education and its types, expressing the causes of self-criticism and its consequences, preparing a diary of daily mistakes and accepting them and the skills to solve them, the exercise of self-esteem and self-worth by mentioning their positive characteristics.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Hajar Salimi
Street address
Ostandari street.
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Email
Salimi85ha@gmail.com
2
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Hajar Salimi
Street address
Hezar jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Salimi85ha@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hajar Salimi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Khorshid Hospital, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Email
Salimi85ha@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hajar Salimi
Position
Assistant professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Khorshid Hospital, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3222 2127
Fax
Email
salimi85ha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Malekmohammadi
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of Psychiatry, Khorshid Hospital, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2127
Fax
Email
malekmohammadi@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