Protocol summary

Study aim
Investigating the efficacy of compassion-focused group therapy on the recovery of prolonged grief disorder caused by suicide
Design
Clinical trial with two groups using web-based randomization and single-blind method using sealed envelopes on 52 subjects
Settings and conduct
After the initial selection of the sample in Kermanshah, which includes survivors with prolonged grief disorder survivors of suicide, who will be structured by questionnaire and clinical interview.52 participants were randomly assigned to experimental groups and waiting list in three stages of pretest, posttest and follow-up ,They will answer the questions of prolonged grief disorder, rumination related to grief, self-compassion, shame, anxiety, depression, avoidance and depressive anxiety and experiential avoidance questionnaires.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ranging in age from 18 to 60 years, having prolonged grief disorder, having a minimum level of secondary education, and survivors have lost a family member to suicide during the last three years. Exclusion criteria: Having acute suicidal thoughts at the time of study, having diagnostic criteria for mood disorders, schizophrenia and post-traumatic stress disorder, having physical illnesses that require urgent medical attention, having any cognitive impairment including Alzheimer's disease with the diagnosis of neurologist
Intervention groups
In the experimental group, 12 sessions of group therapy focused on compassion are performed and no intervention is done in the control group.If the treatment is effective for the control group, group sessions will be held.
Main outcome variables
Symptoms of prolonged grief disorder, grief rumination, self-compassion, shame, anxiety, depression, and experiential avoidance.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230430058032N1
Registration date: 2024-03-10, 1402/12/20
Registration timing: prospective

Last update: 2024-03-10, 1402/12/20
Update count: 0
Registration date
2024-03-10, 1402/12/20
Registrant information
Name
Moslem Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0045
Email address
rajjabimoslem@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-06-22, 1403/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A qualitative study of psychological components in Prolonged grief disorder by suicide, and The Efficacy of Compassion-focused group therapy on The recovery of this disorder
Public title
Efficacy of Compassion-Focused Group Therapy on The Recovery of Prolonged Grief Disorder Symptoms Survivors of Suicide
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from prolonged grief disorder (based on structured clinical interview and getting a score of 30 on prolonged grief disorder questionnaire) Survivors have lost a family member to suicide within the past three years.
Exclusion criteria:
Having severe suicidal thoughts at the time of study Having diagnostic criteria for mood disorders, schizophrenia and post-traumatic stress disorder Having physical illnesses that require urgent medical attention to a specialist Having any cognitive impairment, including Alzheimer's disease, with the diagnosis of neurologists
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
People with prolonged grief disorder are selected using simple randomization method.Individual randomization unit.Through a random table of numbers, which are randomly generated without any pattern or order, the names of the participants will be collected as a set of numbers and the numbers will be used to categorize different groups.Odd numbers are placed in the intervention group and odd numbers in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
First, we create random sequences using web-based randomization.Then, based on the size of the research sample, we prepare a number of envelopes and record each random sequence created on a card, and place the cards in envelopes in order and put them in a box.And according to the order of entry of qualified subjects, we open one of the envelopes and the case group is revealed.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee University of Social Welfare and Rehabilitation Sciences
Street address
khiaban koodak yar. University of Social Welfare and Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2023-03-15, 1401/12/24
Ethics committee reference number
IR.USWR.REC.1401.249

Health conditions studied

1

Description of health condition studied
prolonged grief disorder
ICD-10 code
F43.8
ICD-10 code description
Other reactions to severe stress

Primary outcomes

1

Description
Symptoms of prolonged grief disorder
Timepoint
Pre-test, post-test and follow-up
Method of measurement
prolonged grief disorder questionnaire

2

Description
Grief rumination
Timepoint
Pre-test, post-test and follow-up
Method of measurement
Grief rumination questionnaire

3

Description
shame
Timepoint
Pre-test, post-test and follow-up
Method of measurement
shame questionnaire

4

Description
compassion
Timepoint
Pre-test, post-test and follow-up
Method of measurement
scale of self-compassion

5

Description
anxiety
Timepoint
Pre-test, post-test and follow-up
Method of measurement
Beck Anxiety Questionnaire

6

Description
Depression
Timepoint
Pre-test, post-test and follow-up
Method of measurement
Beck Depression Questionnaire

7

Description
experiential avoidance
Timepoint
Pre-test, post-test and follow-up
Method of measurement
multidimensional Experiential Avoidance Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, 12 sessions of group therapy with a compassion-focused approach will be held. Each session is 120 minutes and there will be one session per week.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah Welfare Center
Full name of responsible person
Ali Islam Parandin
Street address
1 Farhangiyan Ave , Zan Blvd .Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
1687998597
Phone
+98 83 5829 0277
Email
aliparandin@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamid Reza Khankeh
Street address
Koodakyar Ave. University of Rehabilitation and Social Health Sciences
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2000
Email
hamid.khankeh@ki.se
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Moslem Rajabi
Position
Ph.D. Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
385,dampezeshki Ave
City
Tehran
Province
Tehran
Postal code
1347783743
Phone
+98 21 6687 6753
Email
rajjabimoslem@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
moslem rajabi
Position
Ph.D. Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
358, dampezeshki
City
Tehran
Province
Tehran
Postal code
1347783743
Phone
+98 21 6687 6753
Email
rajjabimoslem@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Moslem rajabi
Position
Ph.D. Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
358, dampezeshki Ave
City
Tehran
Province
Tehran
Postal code
1347783743
Phone
+98 21 6687 6753
Email
rajjabimoslem@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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