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The effectiveness of Schema Therapy on Eating Habits, Body Mass Index, weight-related LifeStyle Self-Efficacy, Cognitive Emotion Regulation, Self-management Behaviors, eating Addiction, Coping styles, and Schematic mentality in patients undergoing bariatric surgery

Protocol summary

Study aim
The effectiveness of schema therapy on body mass index, weight-related lifestyle self-efficacy, emotion regulation and schema mentality in people undergoing bariatric surgery
Design
Clinical trials with a control group and blind and randomized intervention group
Settings and conduct
The Ghadir Mother and child hospital in Shiraz, in the experimental group, in addition to receiving the primary care nutritional program after the bariatric surgery, an independent schemata variable will be applied. - In the control group, no independent variables were applied, and they will receive only the nutrition program and primary care after bariatric surgery. - In the independent variable, the schema will be presented in 10 sessions (one session of 1.5 hours per week). - The dependent variables are BMI, lifestyle self-efficacy related to weight, emotional regulation, and schematical mentality. - In the test and control group, two evaluations will be carried out in the pre-test and post-test
Participants/Inclusion and exclusion criteria
Inclusion criteria: Performing bariatric surgery in 1397, the age range of 55-20 years, living in Shiraz, having minimum cycle education, the ability to communicate verbally, patient agreement with written consent to participate in the study. Exclusion criteria: suffering from severe psychiatric disorders and their related problems
Intervention groups
There were 15 people in the experimental group and 15 in the control group
Main outcome variables
Schema Therapy; BMI; Self-efficacy of lifestyle; Weight; Scale Thrice Adjustment and Scheme Mind

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180523039802N2
Registration date: 2020-08-05, 1399/05/15
Registration timing: prospective

Last update: 2020-08-05, 1399/05/15
Update count: 0
Registration date
2020-08-05, 1399/05/15
Registrant information
Name
Zahra Sobhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3227 9711
Email address
zahrasobhani120@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-09, 1399/05/19
Expected recruitment end date
2020-09-09, 1399/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Schema Therapy on Eating Habits, Body Mass Index, weight-related LifeStyle Self-Efficacy, Cognitive Emotion Regulation, Self-management Behaviors, eating Addiction, Coping styles, and Schematic mentality in patients undergoing bariatric surgery
Public title
The effectiveness of Schema Therapy on Eating Habits, Body Mass Index, Weight-related LifeStyle Self-Efficacy, Cognitive Emotion Regulation, Self-management Behaviors and Schema mentality in patients undergoing bariatric surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Performing bariatric surgery in 1397, the age range of 55-20 years, living in Shiraz, having minimum cycle education, ability to communicate verbally, patient agreement with written consent to participate in the study
Exclusion criteria:
Severe mental disorders and their related problems
Age
From 20 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization: 30 people who have the inclusion criteria: 15 people will be selected for the schema therapy in the experimental group and 15 people for the control group were randomly selected by the sealed envelope site. Block sizes were 4, 6, and 8, and the patients selected according to the patient list.
Blinding (investigator's opinion)
Double blinded
Blinding description
The objectives of the research will be explained to the participants. The objectives of the research will be explained to the participants. Neither the participants in the experimental group know that there is a control group nor the participants in the control group know that there is an experimental group. Also, the groups are not related to each other. The health care staff of the obesity clinic who are responsible for caring for patients, data collectors, and those evaluating the outcome are also blind and will not be informed of the objectives of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz university of medical sciences
Street address
Khalili Street, Research Tower of Mohammad Rasool Allah, Colorectal Research Center
City
shiraz
Province
Fars
Postal code
7193635899
Approval date
2019-03-12, 1397/12/21
Ethics committee reference number
IR.SUMS.REC.1398.237

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
1-Weight Loss Life Style Self-Efficacy: This questionnaire, designed and developed by Clark, contains 20 questions about self-efficacy of eating behavior, in which subjects rate their confidence and control in controlling and preventing eating behaviors in different situations. The temptation is based on a five-point Likert scale (from 0 to 0, very reliable, 4). 2. Cognitive Emotion Regulation (DERS): A 36-point scale developed by Graz and Roemer And has a general score and six special scores in the sub-scales that relate to different dimensions of difficulty in tuning the emotion, including Emotional responsiveness, difficulty in targeting behavior, difficulty in controlling impulse, lack of emotional acuity, lack of emotional transparency, and limited access to emotion regulation strategies. 3-Schematic mentality: This questionnaire is a self-report tool with 124 sentences, and the subject must specify, on a 6-point Likert scale, the amount of his consent or opposition to each of the phrases. The higher the individual's score in these mindsets implies the inflexibility of that mentality.
Timepoint
Before the start of the intervention, a pretest is taken and the schema therapy intervention will be performed in 10 sessions and a weekly 1.5 hour session, and then one month after the intervention, post-test will be taken.
Method of measurement
Demographic information questionnaire, Linear scale, Weight Loss Life Style Self-Efficacy, Cognitive Emotion Regulation (DERS), BSSQ, Schematic mentality

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Schema received 10 sessions per week and 1.5 hours per week received
Category
N/A

2

Description
Control group: The control group will not receive any interventions and will be considered as a comparison group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mother and Child Emergency Hospital in Ghadir, Shiraz
Full name of responsible person
masoud amini
Street address
laparascopy Research Center, Mother and Child Hospital Ghadir, above gate Quran, First Town Gulshan
City
Shiraz
Province
Fars
Postal code
71449-9537
Phone
+98 71 3631 9937
Fax
+98 71 3227 9711
Email
aminima@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Vahid Hosseini
Street address
Khalili street, mohammad rasoul allah tower, Colorectal research center
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1453
Email
colorectal@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Sobhani
Position
Post Doc
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
NO. 5 Moallem street, Moallem square
City
Shiraz
Province
Fars
Postal code
7186837152
Phone
+98 71 3631 9937
Email
zahrasobhani120@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
ZAHRA SOBHANI
Position
Postdoctoral student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 5, Moalem Ave, Moralem Square
City
SHIRAZ
Province
Fars
Postal code
7186837152
Phone
0087136319937
Email
zahrasobhani120@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Zabangirfard
Position
Research Expert, Administrative Relationship Expert Translations of Expert
Latest degree
Bachelor
Other areas of specialty/work
Library and Medical Information
Street address
Khalili Street, Research Tower of Mohammad Rasool Allah, Colorectal Research Center
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1453
Email
colorectal2@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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