The Comparison of the effectiveness of mindfulness cognitive group psychotherapy and schema therapy on weight, body image and self-esteem of people with obesity
The Comparison of the effectiveness of mindfulness cognitive group psychotherapy and schema therapy on weight, body image and self-esteem of people with obesity
Design
A randomized clinical trial with parallel groups
Settings and conduct
In order to conduct the research by attending Ravan-Mehr Counseling and Psychology Center, while explaining the nature and aims of the research and obtaining patient consent, individually presented each case, first a preliminary evaluation in terms of body mass index, body image and self-esteem pre-test. The Mindfulness Test group will be divided into 8 sessions of 90 minutes 2 sessions per week, Schema therapy group will be divided into 10 sessions of 90 minutes 2 sessions per week. After the sessions, both groups will again respond to body mass index, body image and self-esteem scales.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Obesity based on physician diagnosis, age range of 30 to 50 years, diploma to postgraduate level, and no chronic illness and mental disorders. Exclusion criteria included non-co-operation of the sample group at each stage of the study, having physical and physical problems and a history of psychiatric problems.
Intervention groups
For the first group of mindfulness cognitive group psychotherapy, For the second group schema therapy will be performed.
Main outcome variables
weight, body image and self-esteem
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200210046451N1
Registration date:2020-03-06, 1398/12/16
Registration timing:retrospective
Last update:2020-03-06, 1398/12/16
Update count:0
Registration date
2020-03-06, 1398/12/16
Registrant information
Name
Afshin Bahadori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2253 1934
Email address
a.bahadori@iaukishint.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-13, 1398/09/22
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the effectiveness of mindfulness cognitive group psychotherapy and schema therapy on weight, body image and self-esteem of people with obesity
Public title
The Comparison of the effectiveness of mindfulness cognitive group psychotherapy and schema therapy on weight, body image and self-esteem of people with obesity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Obesity based on physician diagnosis
age range from 30 to 50 years
diploma level to master's degree
no chronic diseases and mental disorders
Exclusion criteria:
No cooperation of the sample group at each stage of the study
Having physical and physical problems and a history of psychiatric problems
Age
From 30 years old to 50 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
The block randomization method is performed by the statistical consultant as follows: Randomization is performed in two groups of mind-based cognitive group therapy and schema therapy. In block randomization, the number of participants in all groups will be very close together by making blocks of sequences so that the same number of participants are assigned to study groups within each group. We first code the groups in Latin letters as follows:
A = Mindfulness-based cognitive group therapy, B = Schema therapy
In this study, with two groups A and B, we create the following two groups and assign each of the numbers 1 to 2:
-AB-BA
Then we use a random number table to select one of these blocks whenever the numbers 1 and 2 appear, and if there is another number, we consider it null and move on to the next choice. In fact, we have obtained a random sequence of numbers with a random number table that we consider the order of assignment for each number. This way the number of people in the groups will be approximately equal.
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 Hormozgan University Of Medical Sciences
Street address
North Karegar Street 17 Veteran Street 24 P 64
City
Tehran
Province
Tehran
Postal code
1437697419
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.HUMS.REC.1398.336
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
BMI
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
This index is obtained by dividing the weight (in kg) by the square of the height (in meters). Weight will be measured using a digital portable balance scale with sensitivity of 100 grams and height will be measured with a 0.5 meter non-dilatable tape meter.
2
Description
self-steem
Timepoint
Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Cooper Smith Self-esteem Questionnaire
3
Description
Body image
Timepoint
En Measurement will be done in pre-test, post-test and follow-up three months after post-test
Method of measurement
Kash Body Image Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group one: Mindfulness-based cognitive therapy was taught to participants based on Kabat‐Zinn (2012) in 8 sessions (two sessions per week, each session for 90 minutes) and during one month.
Category
Treatment - Other
2
Description
Intervention group II: In this study, intervention based on schema therapy was taught to the participants using the training package Young (1990) in 10 sessions (two sessions per week and each session for 90 minutes) for one and a half months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ravanmehr Consulting and Psychology Center
Full name of responsible person
Afshin Bahadori
Street address
South Kurdistan Highway - 17th Street - Janbazan Street - 24p 61st 4th West
City
Tehran
Province
Tehran
Postal code
2246578941
Phone
+98 21 2288 1908
Email
afshin_bahadori2002@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Roosta
Street address
Islamic Azad University of Kish International Branch, Free Zone Organization Square, Sana'i Boulevard, Kish Island.
City
Kish
Province
Hormozgan
Postal code
7941775883
Phone
+98 76 4442 2720
Email
Info@Iaukishint.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
20
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
Islamic Azad University
Full name of responsible person
Afshin Bahadori
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 5, 7 West Floor, Mellat Square, Alidoust Street, Ostad Hassan Bana North.
City
Tehran
Province
Tehran
Postal code
2248795031
Phone
+98 21 2253 1934
Fax
Email
a.bahadori@iaukishint.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Afshin Bahadori
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 5, 7 West Floor, Mellat Square, Alidoust Street, Ostad Hassan Bana North.
City
Tehran
Province
Tehran
Postal code
2248795031
Phone
+98 21 2253 1934
Fax
Email
a.bahadori@iaukishint.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Afshin Bahadori
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 5, 7 West Floor, Mellat Square, Alidoust Street, Ostad Hassan Bana North.
City
Tehran
Province
Tehran
Postal code
2248795031
Phone
+98 21 2253 1934
Fax
Email
a.bahadori@iaukishint.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
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
En Only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long
En Start of access period 6 months after printing results
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
ny type of analysis on the data delivered is permitted
From where data/document is obtainable
No. 5, 7 West Floor, Mellat Square, Alidoust Street, Ostad Hassan Bana North.
postal code: 2248795031
Tel: 00982122531934
What processes are involved for a request to access data/document
The request will be sent by email to: afshin_bahadori2002@yahoo.com