We aim to investigate the effect of group cognitive behavior therapy on body image, attachment style and emotion regulation in people with eating disorder.
Design
After doing pretest if criteria is met, patient will be assigned randomly into intervention and control group. Patient in intervention group will receive 12 sessions of two hour CBT group therapy over the course of 12 weeks. Treatment protocol was designed by Michael Free. Patient in control group will be stayed on waiting list.
Settings and conduct
After the diagnostic interview by the clinical psychologist, patients diagnosed with eating disorder are randomly assigned to the intervention and control groups. Assessment is also performed immediately after the intervention. The site of the interview and interventions is the modern health care clinic.
Participants/Inclusion and exclusion criteria
inclusion criteria: diagnosed as eating disorder using DSM5 criteria
age between 18 and 45 years
exclusion criteria: substance abuse
receiving psychotherapy within last year
Intervention groups
Intervention and control group
Patients in intervention group will receive 12 sessions of two hour CBT group therapy over the course of 12 weeks.Patient in control group will be stayed on waiting list.
Main outcome variables
Body Image; Attachment Style; Emotion Regulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190911044746N1
Registration date:2019-10-01, 1398/07/09
Registration timing:prospective
Last update:2019-10-01, 1398/07/09
Update count:0
Registration date
2019-10-01, 1398/07/09
Registrant information
Name
Sadegh Rahmati
Name of organization / entity
The University of Allameh tabataba'i
Country
Iran (Islamic Republic of)
Phone
+98 21 4452 3262
Email address
sadegh_rahmati@atu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-07, 1398/07/15
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cognitive behavior group therapy on body image, attachment style and emotion regulation in people with eating disorder
Public title
Effect of cognitive behavior group therapy in people with eating disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed of eating disorders using DSM5 criteria
age between 18 and 45 years
Exclusion criteria:
Substance abuse
Receiving psychotherapy within last year
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
After doing pretest, if inclusion criteria is met, patient will be assigned randomly into experiment and control group using simple randomization. randomization will be done using Stata 9.0 computer program.
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 of Allameh Tabataba'i University
Street address
Research division, Allameh Tabataba'i University, Dehkadeh Olympic, west Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1489684511
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.ATU.REC.1398.003
Health conditions studied
1
Description of health condition studied
Anorexia Nervosa
ICD-10 code
F50.0
ICD-10 code description
Anorexia nervosa
2
Description of health condition studied
Bulimia Nervosa
ICD-10 code
F50.2
ICD-10 code description
Bulimia nervosa
3
Description of health condition studied
Binge eating
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Body Image
Timepoint
Before and immediately after the intervention
Method of measurement
Satisfaction with Body Image scale
2
Description
Attachment style
Timepoint
Before and immediately after the intervention
Method of measurement
Adult Attachment inventory
3
Description
Emotion regulation
Timepoint
Before and immediately after the intervention
Method of measurement
Difficulties in Emotion Regulation Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in intervention group will receive 12 sessions of two hour CBT group therapy over the course of 12 weeks. Treatment protocol was designed By Michael Free.
Category
Behavior
2
Description
Control group: patients in control group will be stayed on waiting list.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Modern health care clinic
Full name of responsible person
Shirin Adel
Street address
No. 21, Yazdan panah Ave, Jordan
City
Tehran
Province
Tehran
Postal code
1968876456
Phone
+98 21 8867 4285
Email
Morteza_oghbaie@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Allameh Tabataba'i
Full name of responsible person
Hamidreza Oloumi yazdi
Street address
Research division, Allameh Tabataba'i University, Dehkadeh Olympic, west Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4473 7561
Email
Oloumi@atu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Allameh Tabataba'i
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
The University of Allameh Tabataba'i
Full name of responsible person
Ahmad Borjali
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of psychology and educational sciences, Allameh Tabataba'i University, Dehkadeh Olympic, west Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 3202
Email
Borjali@atu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Allameh Tabataba'i
Full name of responsible person
Sadegh Rahmati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No 9., 6th Alley, North rajaie Ave, tehransar
City
Tehran
Province
Tehran
Postal code
1388716541
Phone
+98 21 4452 3262
Email
Sadegh_rahmati@atu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Allameh Tabataba'i
Full name of responsible person
Sadegh Rahmati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 9, 6th Alley, North rajaie Ave, Tehransar
City
Tehran
Province
Tehran
Postal code
1388716541
Phone
+98 21 4452 3262
Email
Sadegh_rahmati@atu.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the recorded data from statistical samples will be available to help understand the research topic and its impacts.
When the data will become available and for how long
Since 2020
To whom data/document is available
Researchers in university centers
Under which criteria data/document could be used
The use of documentation is permitted in the development of research
From where data/document is obtainable
Faculty of psychology and educational sciences, Allameh Tabataba'i University, Tehran
What processes are involved for a request to access data/document