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Comparison of Effectiveness of Integrative Group Psychotherapy and Cognitive-Behavioral Stress Management Therapy Group on the Body Image, Somatic Symptom, Mindful Eating and The Satisfaction With Therapy and Therapist in Obese People

Protocol summary

Study aim
Comparison of Effectiveness of Integrative Group Psychotherapy and Cognitive-Behavioral Stress Management Therapy Group on Body Image, somatic Symptoms, mindful Eating and the Satisfaction with Treatment and Therapy in Obese People
Design
The research used a quasi-experimental study with a pretest-posttest design multi-group.
Settings and conduct
people who will enter the research, first be explained by the researcher on the importance and purpose of the research, and will complete and sign a written informed consent form, and will explain to them that in this research three sessions absence is considered as a criterion out and is deprived of collaborative research.
Participants/Inclusion and exclusion criteria
The sample selection criteria for the study were female; age range 20 to 45 years, body mass index equal or greater than 30, upper elementary education, their obesity was not due to other underlying diseases, lack of major psychiatric disorder, lack of history of weight loss Programs
Intervention groups
In this study, intervention group 1 (Integrative group psychotherapy) will conduct 90 minute 1 session per week , Integrative group psychotherapy. Intervention group 2 (Cognitive Behavioral Stress Management Therapy group) will receive 90 minute 1 session per week, Cognitive Behavioral Stress Management Therapy group. The control group will not receive any intervention during intervention groups training, but they will also receive training.
Main outcome variables
Body image, Mindful eating, somatic symptoms, and satisfaction with treatment and therapist

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181214041964N1
Registration date: 2019-10-04, 1398/07/12
Registration timing: retrospective

Last update: 2019-10-04, 1398/07/12
Update count: 0
Registration date
2019-10-04, 1398/07/12
Registrant information
Name
Khadijeh Babakhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3372 3895
Email address
khadijeh.babakhani@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-19, 1398/01/30
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Effectiveness of Integrative Group Psychotherapy and Cognitive-Behavioral Stress Management Therapy Group on the Body Image, Somatic Symptom, Mindful Eating and The Satisfaction With Therapy and Therapist in Obese People
Public title
Effectiveness of Integrative Group Psychotherapy and Cognitive-Behavioral Stress Management in Obese People
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female gender 20 to 45 years BMI equal to or greater than 30 higher level primary education
Exclusion criteria:
Obesity is not due to other underlying illnesses no major disorder in psychiatry no history of participation in weight loss programs
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Accordingly, 60 patients will be selected at a 3-month intervals in eligible individuals, and after assigning the sample, I will randomly allocate the subjects to the test and control groups.
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 of Karaj
Street address
Unit 3, No 1242, West 3 bokharaei st, Golshar 1.
City
zanjan
Province
Zanjan
Postal code
4514133839
Approval date
2018-06-27, 1397/04/06
Ethics committee reference number
IR.IAU.K.REC.1397.029

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
body image.
Timepoint
In this study, body image variable will be measured at the beginning of the study (before the intervention), at the end of the intervention and 90 days after the intervention.
Method of measurement
body image questionnaire.

2

Description
mindful eating.
Timepoint
In this study, mindful eating variable will be measured at the beginning of the study (before the intervention), at the end of the intervention and 90 days after the intervention.
Method of measurement
mindful Eating Questionnaire.

3

Description
somatic symptoms.
Timepoint
In this study, somatic Symptoms variable will be measured at the beginning of the study (before the intervention), at the end of the intervention and 90 days after the intervention.
Method of measurement
Adapted from the Patient Health Questionnaire Physical Symptoms.

4

Description
satisfaction With Therapy and Therapist .
Timepoint
In this study, Satisfaction With Therapy and Therapist variable will be measured at the beginning of the study (before the intervention), at the end of the intervention and 90 days after the intervention.
Method of measurement
client satisfaction questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
intervention group 1 (Integrated group psychotherapy): intervention group 1 will receive intervention 9 sessions (Farah Lotfi Kashani & Vaziri, 2016) in 90 minute per week 1 session. Control group will be considered as a comparison.
Category
Treatment - Other

2

Description
Intervention group 2: intervention group 2 will receive intervention 9 sessions (Michael Anthony, translation of Neshat Doost et al.2017) in 90 minutes per week 1 session . Control group will be considered as a comparison.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
No 16, Health Service Center
Full name of responsible person
khadijeh Babakhani
Street address
Next to the Alibinabitalb mosque, Kaj st, west Shahrak
City
zanjan
Province
Zanjan
Postal code
4514133839
Phone
+98 24 3352 7707
Email
kh.babakhani6@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The Karaj Branch, Islamic Azad University Research Assistantance
Full name of responsible person
Farede Naderi
Street address
Esteglal and Moazen Blv Intersection , End of Rajaei shahr, Karaj
City
karaj
Province
Alborz
Postal code
3149968111
Phone
+98 26 3418 2727
Email
partoo2009@yahoo.com‏
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Karaj Branch, Islamic Azad University Research Assistantance
Proportion provided by this source
90
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
Khadijeh Babakhani
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 3, NO 1242, West 3 Bokhararey, Golshar 1
City
Zanjan
Province
Zanjan
Postal code
4514133839
Phone
+98 24 3372 3895
Email
Kh.babakhani6@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahram Vaziri
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 10, Floor 3, No 119, Pezeshkan Building- Before motahari, Ghaem Magham Farahani St
City
Tehran
Province
Tehran
Postal code
4514133839
Phone
+98 21 8830 5686
Email
Shahram.aziri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahram Vaziri
Position
Psychologist
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Unit 10, Floor 3, No 119, Pezeshkan building- Before motahari, Ghaem magham Farahani St
City
Tehran
Province
Tehran
Postal code
4514133839
Phone
+98 21 8830 5686
Email
Shahram.vaziri@gmail.com

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
This file is confidential.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
There is no program to publish
When the data will become available and for how long
none
To whom data/document is available
No decision has been made.
Under which criteria data/document could be used
Now something is unclear
From where data/document is obtainable
Will be notified.
What processes are involved for a request to access data/document
I do not have this answer right now
Comments
Most of my efforts are to use these psychological treatments in obese and other illnesses.
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