The effectiveness of compassion focused therapy on reducing feelings of guilt, shame, self criticism, psychological distress and social isolation in people with eating disorder
The study of effectiveness of compassion focused therapy on reducing feelings of guilt , shame, self criticism,psychological distress and social isolation in people with eating disorder
Design
This clinical trial has control group , with two arm parallel group without blinding , simple randomized on 30 persons who suffer from Bulimia nervosa.
Settings and conduct
This clinical trial has control group , with two arm parallel group without blinding , simple randomized on 30 persons who suffer from Bulimia nervosa. This method is for the client who refer to Hakim Medical group with Bulimia nervosa disorder in eight session and Compassion-focused therapy protocol According to the content of the treatment sessions will be executed.
Participants/Inclusion and exclusion criteria
Having Bulimia nervosa disorder, consent , Sex:female and Age:18-40 and nothing else.
Intervention groups
The females between 18 -40 who suffer from Bulimia nervosa will Participate in this intervention . they will divide in two group 1- subject with compassion focused therapy and 2- control without it.
Main outcome variables
The main outcomes are feeling guilty; shame; self criticism; psychological distress and social isolation.
General information
Reason for update
Acronym
پرخوری عصبی
IRCT registration information
IRCT registration number:IRCT20210407050888N1
Registration date:2022-11-17, 1401/08/26
Registration timing:prospective
Last update:2022-11-17, 1401/08/26
Update count:0
Registration date
2022-11-17, 1401/08/26
Registrant information
Name
Seyed Ali Akbar Karimi Ah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2234 2246
Email address
stu.aliakbarkarimiah@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of compassion focused therapy on reducing feelings of guilt, shame, self criticism, psychological distress and social isolation in people with eating disorder
Public title
The effectiveness of compassion on bulimia nervosa
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Bulimia nervosa disorder
sex: female
Age : 18-40
Having informed consent of participate in this research.
Exclusion criteria:
hyper activity or hypo activity in thyroid
pregnancy
drug and alcohol abuse
inability to perform intervention tasks
overweight treatment of drug
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, simple individual randomization method will be used. In this way, the identified people with bulimia nervosa disorder will be organized into two groups of 15 people (experimental and control) by simple randomization method. A table of random numbers will be used for randomization.
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
Islamic Azad University -Sari Branch
Street address
Azad university -seventh kilometer- daria Blvd
City
Sari
Province
Mazandaran
Postal code
4816119318
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
IR.IAU.SARI.REC.1399.154
Health conditions studied
1
Description of health condition studied
bulimia nervosa disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The main variable in this trial is Bulimia nervosa that Eligible people to enter the research by participating in the test The Eating Attitudes Test (EAT-26) will be identified.
Timepoint
Two months
Method of measurement
The Self-Compassion Scale Short Form (SCS-SF; Raes et al., 2011) with 26 items.
Secondary outcomes
1
Description
Bulimia nervosa,
Timepoint
Two months
Method of measurement
The Eating Attitudes Test (EAT-26) is used to identify the presence of “eating disorder with 26 items.
2
Description
Feelings of guilt
Timepoint
Two months
Method of measurement
For this variable Guilt and Shame Proneness Scale (GASP) 2011 Cohen, T. R., Wolf, S. T., Panter, A. T., & Insko, C. A. whit 16 items is used.
3
Description
Shame
Timepoint
Two months
Method of measurement
For this variable Guilt and Shame Proneness Scale (GASP) 2011 Cohen, T. R., Wolf, S. T., Panter, A. T., & Insko, C. A. whit 16 items is used.
4
Description
Self criticism
Timepoint
Two months
Method of measurement
Exploring self-criticism — The Levels of Self-criticism Scale Thompson & Zuroff, 2004 is a 22-item self-report
5
Description
Psychological distress
Timepoint
Two months
Method of measurement
For this variable Depression Anxiety and Stress Scale 21 (DASS-21) whit 21 items is used.
6
Description
Social isolation
Timepoint
Two months
Method of measurement
For this variable, to measure one's subjective feelings of loneliness as well as feelings of social isolation(Russell, Peplau & Cutrona) with 20 items is used
Intervention groups
1
Description
There is two months for Compassion-focused therapy training. One session in every week and a total of eight sessions. For each sessions will explain about the disorder, characteristics, intervening factors, examination Physiological effects of hormones, coping methods, mindfulness, training related to treatment focused on compassion that is appropriate and in accordance with the protocol of this type of treatment. Safety strategies, concentration, correct breathing, yoga, compassionate letter, Mantra and mindfulness eating will be experienced .At the beginning, the bulimia nervosa diagnostic tool is used to ensure the existence of this disorder. After identifying the existence of this disorder, thirty people will considered for the research work and from this number, two groups of fifteen people were randomly separated with the names of the control group and the experimental group. At this stage, both groups will be given consent forms and personal information, so that after completing it, they will enter the stage of the tests. A single pre-test is used for both groups, with the difference that the test sheets of the control group with a letterhead (PRE.T.CO) means the pre-test or pre-test of the control group, and the papers of the subject group with a letterhead (PRE.T.A) ) means pre-test or pre-test of the subject group. This apparent separation is to compare the answers given by each person at the end of the research and has no other reason. After the end of the eighth session, the same test was again given to the same people who were in the control group, but this time with the post-test with a sheet of paper (POST.T.CO) and to the same people of the first subject group, the same test but this time. It is given with the header (POST.T.A) which means post-test and after that it will be time to check and analyze the data.
Category
Behavior
2
Description
Control group: we haven't any intervention for this group and only pretest and post-test is used for them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Hakim Medical group
Full name of responsible person
Mastaneh Tabesh
Street address
No.49, Neiam Alley, Shariaty Ave.Tehran Town
City
Tehran
Province
Tehran
Postal code
1948853951
Phone
+98 21 2664 4853
Fax
+98 21 2664 4853
Email
Mastaneh.tabesh@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Ali Akbar Karimi Ah
Street address
Islamic Azad University - Sari Mazandaran Province, Farah Abad Rd, Iran
City
Sari
Province
Mazandaran
Postal code
۱۹۳۱۸-۴۸۱۶۱
Phone
+98 11 3303 2891
Fax
+98 11 3303 3751
Email
Aliakbarkarimiah@yahoo.com
Web page address
https://sari.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University - Sari Mazandaran
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Ali Akbar Karimi AH
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University - Sari Mazandaran Province, Farah Abad Rd, Iran
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
۰۱۱۳۳۰۳۲۸۹۱ ,۰۱۱۳۳۱۷۵۳۳۳
Fax
+98 11 3303 3751
Email
aliakbarkarimiah@yahoo.com
Web page address
https://sari.iau.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Ali Akbar Karimi Ah
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University - Sari Mazandaran Province, Farah Abad Rd, Iran
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
۰۱۱۳۳۰۳۲۸۹۱ ,۰۱۱۳۳۱۷۵۳۳۳
Fax
+98 11 3303 3751
Email
Aliakbarkarimiah@yahoo.com
Web page address
https://sari.iau.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Ali Akbar Karimi Ah
Position
university student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Seventh kilometer in Darya Ave.Sari.Mazandaran.
City
Sari
Province
Mazandaran
Postal code
4816119318
Phone
۰۱۱۳۳۱۷۵۳۳۳ , ۰۱۱۳۳۰۳۲۸۹۱
Fax
+98 11 3303 3751
Email
Aliakbarkarimiah@yahoo.com
Web page address
https://sari.iau.ir/fa
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
There is not more information.
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
consent form
When the data will become available and for how long
After intervention for ever.
To whom data/document is available
Every one
Under which criteria data/document could be used
unconditionally
From where data/document is obtainable
aliakbarkarimiah@yahoo.com
What processes are involved for a request to access data/document