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effectiveness of emotion-focused therapy (EFT) on anger, guilt feeling and self-destructive behaviors In people with Prolonged Grief Disorder

Protocol summary

Study aim
Effectiveness of emotion-focused therapy (EFT) on guilt feeling, anger and self-destructive behaviors in people with Prolonged Grief Disorder.
Design
Randomization will be simple randomization. The randomization unit is people. 40 subjects between the ages of 18 and 60 will be divided into intervention and control groups using Microsoft Excel software, rand section. Based on this, a table of random numbers is prepared and the Randbetween function is created, and the subjects are placed in two groups of 20 people according to the rows of this table.
Settings and conduct
The treatment will be conducted online, 1 session per week, each session will be 1 hour.
Participants/Inclusion and exclusion criteria
: having informed consent, loss of relatives, age range between 18 and 60 years, having literacy, no history/current presence of severe psychiatric diseases or alcohol or drug use based on (5-RV: DSM-5-SCID), scoring higher than the cut-off point in grief questionnaires (scoring higher than 102), anger, guilt (scoring score higher than 135) and self-destructive behaviors (score higher than 5). : stressful events after entering the study , entering other psychological intervention courses, frequent absences from treatment sessions, starting to take psychiatric drugs , having suicidal thoughts during treatment.
Intervention groups
20 peoplen were randomly placed in the control group and 20 people in the experimental group, and then the experimental group underwent treatment focused on emotion, and the control group was not treated during that period of time. However, due to the ethics of the research, the control group was also subjected to emotion-focused therapy after completing the study.
Main outcome variables
anger، guilt feeling. Self-destructive behaviors

General information

Reason for update
Acronym
EFT بر خشم، احساس گناه و رفتارهای خود تخریبی در PGD
IRCT registration information
IRCT registration number: IRCT20231103059943N1
Registration date: 2024-05-18, 1403/02/29
Registration timing: prospective

Last update: 2024-05-18, 1403/02/29
Update count: 0
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
zeynab akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5551 0879
Email address
zakbarisardehlaghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-20, 1403/03/31
Expected recruitment end date
2024-08-10, 1403/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effectiveness of emotion-focused therapy (EFT) on anger, guilt feeling and self-destructive behaviors In people with Prolonged Grief Disorder
Public title
effectiveness of emotion-focused therapy on Prolonged Grief Disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
having informed consent, loss of relatives, age range between 18 and 60 years, having literacy, no history/current presence of severe psychiatric diseases or alcohol or drug use based on (5-RV: DSM-5-SCID), scoring higher than the cut-off point in grief questionnaires (scoring higher than 102), anger, guilt feeling(scoring score higher than 135) and self-destructive behaviors (score higher than 5). Also, at least 1 year has passed since the death of their loved ones, and the deceased must be a first-degree relative of the subject.
Exclusion criteria:
. stressful events after entering the study (such as death of relatives), entering other psychological intervention courses (simultaneous participation in other psychotherapies), frequent absences from treatment sessions (three sessions) and more), starting to take psychiatric drugs (including antidepressants, anti-anxiety and other psychiatric drugs that may affect the dependent variables of this research), having suicidal thoughts during treatment.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be simple randomization. The randomization unit is people. 40 subjects between the ages of 18 and 60 will be divided into intervention and control groups using Microsoft Excel software, rand section. Based on this, a table of random numbers is prepared and the Randbetween function is created, and the subjects are placed in two groups of 20 people according to the rows of this table.
Blinding (investigator's opinion)
Single blinded
Blinding description
A diagnostic interview (5-RV:DSM-5-SCID) will be conducted online by a PhD student in clinical psychology who was unaware of the research topic.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University shahid beheshti of Medical Sciences
Street address
araabi
City
tehran
Province
Tehran
Postal code
63113-19839
Approval date
2021-11-14, 1400/08/23
Ethics committee reference number
IR.SBMU.MSP.REC.1400.556

Health conditions studied

1

Description of health condition studied
Prolonged Grief Disorder
ICD-10 code
F54
ICD-10 code description
Psychological and behavioral factors associated with disorders or diseases classified elsewhere

Primary outcomes

1

Description
Scores of clients in , anger (STAXI-2), guilt (GFQ) and self-destructive behaviors (SHI) questionnaires.
Timepoint
The beginning of treatment. Completion of treatment. 3 months after completion of treatment
Method of measurement
Grief (GEQ), anger (STAXI-2), guilt (GFQ) and self-destructive behaviors (SHI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The intervention is an emotion-focused treatment according to Greenberg's (2015) protocol, which is in the form of 10 1-hour sessions that will be conducted individually and online once a week. The first session includes establishing communication commitment in treatment, establishing a relationship through advanced with empathy, introducing emotion-oriented therapy, the content of the second session providing emotional education (recognizing emotion and arousing situations, through teaching the difference in performance of different types of emotions), information It will be about different dimensions of emotion and the short-term and long-term effects of emotions. In the third session, the emphasis will be on assessing the level of vulnerability and emotional skills and working with an empty chair about the deceased person, and the fourth session will be about facing emotions related to anger towards the death. and the content of the fifth session will be identifying and controlling the needs, desires and underlying factors of emotions. In the sixth and seventh sessions, the identification of specific emotions related to guilt and self-destruction will be considered, especially in the context of the deceased and other survivors, and in the eighth session An attempt is made to reach a new point of view. The most important content of the ninth session of his training will be creating meaning in the context of death and the last session will be validation, empathic acknowledgment, helping clients to identify progress and maintain results.
Category
Behavior

2

Description
Control group:the period of time that the intervention group will be treated. However, due to the ethics of the research, the control group will be treated with emotion-focused therapy after the study is completed.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleqani Hospital
Full name of responsible person
Zeynab Akbari
Street address
Parand. shahrak salam
City
tehran
Province
Tehran
Postal code
3763861859
Phone
+98 21 5551 0879
Email
zakbarisardehlaghi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Araabi
City
tehran
Province
Tehran
Postal code
63113-19839
Phone
+98 21 2243 9770
Email
Info@sbmu.ac.ir
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
Zeynab Akbari
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tehran. parand. hello town.
City
Tehran
Province
Tehran
Postal code
3763861859
Phone
+98 21 5551 0879
Fax
Email
zakbarisardehlaghi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zeynab Akbari
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tehran. parand. hello town.
City
Tehran
Province
Tehran
Postal code
3763861859
Phone
+98 21 5551 0879
Fax
Email
zakbarisardehlaghi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zeynab Akbari
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Tehran. parand. .
City
Tehran
Province
Tehran
Postal code
3763861859
Phone
+98 21 5551 0879
Fax
Email
zakbarisardehlaghi@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
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