Protocol summary

Study aim
Comparison of the effectiveness of emotion-oriented therapy, therapy focused on self-compassion and physical exercise (yoga) on the experience of shame, self-esteem, attachment styles and self-efficacy of women with binge eating disorder (BED)
Design
Experimental research method - available sampling method of 80 people with binge eating disorder (BED) in 4 groups by a simple random method with a sealed envelope and with unblinded parallel groups. Training of emotion-oriented treatments, self-compassion, physical exercise of yoga and control group (20 people in each group) Post-test for 4 groups in the same conditions After 60 days follow-up phase
Settings and conduct
This research is conducted in a psychology clinic located in Tehran, in the form of group training for two groups with psychotherapy intervention, EFT, CFT, and the third group with yoga intervention in a yoga hall.
Participants/Inclusion and exclusion criteria
Diagnosis of binge eating disorder (BED) based on clinical interview based on DSM-5 Diagnosis of binge eating disorder (BED) of the sample based on the binge eating scale (cut point 16 and above) Absence of drug treatment for weight loss before the research Not abusing tobacco, drugs and cigarettes Failure to enter - Taking psychiatric and psychoactive drugs Absence of more than 2 sessions in therapy sessions Simultaneous participation in other courses and therapeutic interventions at the same time as research Suffering from psychiatric disorders based on the person's own report Abuse of drugs and medicine
Intervention groups
Emotional therapy training - Self-compassion therapy training - yoga-control practice
Main outcome variables
self-esteem, self-efficacy, attachment ,shame

General information

Reason for update
Acronym
EFT-CFT-BED
IRCT registration information
IRCT registration number: IRCT20230125057220N1
Registration date: 2023-01-30, 1401/11/10
Registration timing: retrospective

Last update: 2023-01-30, 1401/11/10
Update count: 0
Registration date
2023-01-30, 1401/11/10
Registrant information
Name
maryam Sarooghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7700 8192
Email address
m.srooghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
2022-05-22, 1401/03/01
Actual recruitment end date
2022-07-06, 1401/04/15
Trial completion date
2022-12-06, 1401/09/15
Scientific title
The comparison of effectiveness of emotion-focused therapy, self- compassion-focused therapy and physical exercise (yoga) on experience of shame, self-esteem, attachment styles and self-efficacy in women with Binge Eating Disorder
Public title
The comparison of effectiveness of emotion-focused therapy, self- compassion-focused therapy and physical exercise (yoga) in women with Binge Eating Disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent to participate in research with Binge Eating Disorder based on DSM-5 Diagnosing binge eating disorder (BED) of the subject based on the binge eating scale (cut point 16 and above) Lack of drug treatment for weight loss before the research No abuse of tobacco, drugs and cigarettes
Exclusion criteria:
Taking psychiatric and psychoactive drugs Absence of more than 2 sessions in treatment sessions Simultaneous participation in other courses and therapeutic interventions at the same time as research Having psychiatric disorders based on the person's self-report drug abuse and smoking
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
available sampling method, Simple randomization: each individual was given 4 sealed envelopes in the number of groups (3 experimental groups and one control group), and based on the choice of an envelope by the individual, his/her placement in a group is done.
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
Ethics committee in research of Islamic Azad University, Borujerd branch
Street address
FIRST FLOOR,NO7,behesht 7 alley, behesht bulivar, hakimiyeh town, Tehran pars
City
Thehran
Province
Tehran
Postal code
165974978
Approval date
2022-08-14, 1401/05/23
Ethics committee reference number
IR.IAU.B.REC.1401.018

Health conditions studied

1

Description of health condition studied
Binge Eating Disorder
ICD-10 code
F50.2
ICD-10 code description
Bulimia nervosa

Primary outcomes

1

Description
Internal shame score
Timepoint
Before the start of the intervention (pre-intervention) - after the last session of the intervention (post-test) - 2 months later (follow-up)
Method of measurement
Cook's Internal Shame Scale (ISS)

2

Description
External Shame Scale
Timepoint
Before the start of the intervention (pre-intervention) - after the last session of the intervention (post-test) - 2 months later (follow-up)
Method of measurement
External Shame Scale (OAS) Goss et al.

3

Description
Self-esteem score
Timepoint
Before the start of the intervention (pre-intervention) - after the last session of the intervention (post-test) - 2 months later (follow-up)
Method of measurement
Self-esteem (RSEs) Rosenberg

4

Description
adult attachment styles score
Timepoint
Before the start of the intervention (pre-intervention) - after the last session of the intervention (post-test) - 2 months later (follow-up)
Method of measurement
Collins and Reed scale of adult attachment styles

5

Description
self-efficacy score
Timepoint
Before the start of the intervention (pre-intervention) - after the last session of the intervention (post-test) - 2 months later (follow-up)
Method of measurement
Lifestyle self-efficacy questionnaire on weight (WELSQ)

6

Description
BED binge eating disorder score
Timepoint
Before the start of the intervention (pre-intervention) - after the last session of the intervention (post-test) - 2 months later (follow-up)
Method of measurement
Binge Eating Severity Scale (BES) Gomali et al

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: 10 sessions of focused emotional therapy
Category
Other

2

Description
Intervention group 2: 10 weeks and 3 sessions per week (30 sessions in total) yoga training
Category
Other

3

Description
Intervention group 3: 10 sessions of self-compassion therapy
Category
Other

4

Description
Control group:
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychology clinic
Full name of responsible person
Maryam sarooghi
Street address
FIRST FLOOR,NO7,behesht 7 alley, behesht bulivar, hakimiyeh town, Tehran pars
City
Tehran
Province
Tehran
Postal code
1659749783
Phone
+98 21 7700 8192
Email
m.srooghi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
personal
Full name of responsible person
maryam sarooghi
Street address
FIRST FLOOR,NO7,behesht 7 alley, behesht bulivar, hakimiyeh town, Tehran pars
City
tehran
Province
Tehran
Postal code
1659749783
Phone
+98 912 477 2316
Email
m.srooghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
personal
Proportion provided by this source
100
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 Brojerd
Full name of responsible person
maryam sarooghi
Position
phd -student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Yadgar Imam St. Nawab Square , Borujerd
City
Borujerd
Province
Lorestan
Postal code
6915136111
Phone
+98 66 4251 8000
Email
m.srooghi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Sarooghi
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Hakimiyeh-Bahar BLV-behesht ST-behesh7 vallay- no7
City
Tehran
Province
Tehran
Postal code
1659749783
Phone
+98 21 7700 8192
Fax
Email
m.srooghi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Sarooghi
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Hakimiyeh-Bahar BLV-behesht ST-behesh7 vallay- no7
City
Tehran
Province
Tehran
Postal code
1659749783
Phone
+98 21 7700 8192
Fax
Email
m.srooghi@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
all data
When the data will become available and for how long
six month after printing
To whom data/document is available
researchers
Under which criteria data/document could be used
For the purpose of scientific research
From where data/document is obtainable
Sites - University
What processes are involved for a request to access data/document
online search
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