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effect of mindfulness-based stress management therapy on the emotion regulation ,anxiety ,depression and food addiction in obese pople

Protocol summary

Study aim
Determinig the effect of Mindfulness-Based Stress Management Therapy on the Emotion regulation, Anxiety, Depression and Food Addiction in Obese People
Design
Sample: Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
The researcher will refer to the health centers and specialized clinics related to weight management with letter from Kashan University of Medical Sciences and select eligible people and call them and invites candidates participates in intervention sessions.
Participants/Inclusion and exclusion criteria
BMI> 30, A score above 5 on the Food Addiction Scale,    Minimum Cycle Education Exclusion criteria:, Participate in a regular exercise program, Absence in treatment sessions more than 2 times, Having a drug addiction, Use of diet، Medical problems such as diabetes and endocrine disorders, hypothyroidism or hyperthyroidism
Intervention groups
Intervention Group: Mindfulness-Based Stress Reduction is an eight-session, 90-minute intervention that teaches participants to communicate with their inner and outer world in the present moment, without judgment, with full awareness and awareness. This approach is based on the treatment protocol of Kabat Zain (2013). Control group: Includes eight one-hour sessions on topics such as: Referrals and meeting group members-General psychology topics that lack emotion regulation topics:Examples: types of conditioning and learning, types of memory, theory of forgetfulness, social psychology, various aspects of adult development.
Main outcome variables
emotions regulation, anxiety, depression, food addiction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190804044436N1
Registration date: 2020-02-06, 1398/11/17
Registration timing: retrospective

Last update: 2020-02-06, 1398/11/17
Update count: 0
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
hanieh kebriti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5545 1898
Email address
m.kebriti20@gamail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-21, 1398/06/30
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of mindfulness-based stress management therapy on the emotion regulation ,anxiety ,depression and food addiction in obese pople
Public title
effect of mindfulness-based stress management therapy on the emotion regulation ,anxiety ,depression and food addiction in obese pople
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI>30 Ages 18 to 50 Score higher than 5 on the Food Addiction Scale A score above 7 on the DASS-21 Depression Scale A score above 6 on the DASS-21 Anxiety Scale Minimum Cycle Education
Exclusion criteria:
Acute psychiatric disorders such as psychosis and bipolar disorder and body dysmorphic disorder Participate in a regular exercise program Taking supplements for weight loss Absence of more than two sessions of treatment Substance abuse Simultaneous psychological treatment
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be based on the random numbers table and hiding with the help of sealed envelopes kept by the clinic manager, whereby individuals will be placed in one of the MBSR and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, evaluators and data analyzers will not be aware of the allocation of individuals to MBSR and control groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences Ethics Committe, Ravandi Boulevard , Kahan
City
kashan
Province
Isfehan
Postal code
3713979671
Approval date
2019-02-18, 1397/11/29
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.111

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity

Primary outcomes

1

Description
Anxiety
Timepoint
Before the intervention, after the intervention, three months after the intervention
Method of measurement
DASS_21 Depression Anxiety Inventory

2

Description
Depression
Timepoint
Before the intervention, after the intervention, three months after the intervention
Method of measurement
DASS_21 Depression Anxiety Inventory

3

Description
food addiction
Timepoint
Before the intervention, after the intervention, three months after the intervention
Method of measurement
Food Addiction Questionnaire (YFAS)

Secondary outcomes

1

Description
Emotion Regultion
Timepoint
Before intervation, After intervation , three month after intervation
Method of measurement
Difficulty adjusting the excitement (DERS)

Intervention groups

1

Description
Intervention group: Mindfulness-Based Stress Reduction is an eight-session, 90-minute intervention that teaches participants to communicate with their inner and outer world in the present moment, without judgment, with full awareness and awareness. . This approach is based on the treatment protocol of Kabat Zain (2013).
Category
Treatment - Other

2

Description
Control group: Includes eight one-hour sessions once a week with topics in general psychology and no emotion-related training including: types of conditioning, types of memory, types of learning, theory of forgetfulness, social psychology, adult developmental theories, Personality Types, Review of Tutorials.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers
Full name of responsible person
Hanieh Kebriti
Street address
Kashan University of Medical Sciences., GHotb Ravandi Blvd.,Kashan Town
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5545 1898
Email
m.kebriti20@gmail.om

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Banafsheh
Street address
Kashan University of Medical Sciences, Ravandi Boulevard , Kashan Town
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 2999
Email
medicine@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Hanieh Kebriti
Position
Studant
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences., GHotb Ravandi Blvd.,Kashan Town
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5545 1898
Email
m.kebriti20@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hanieh Kebriti
Position
Studant
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences., GHotb Ravandi Blvd.,Kashan Town
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5545 1898
Email
m.kebriti20@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hanieh Kebriti
Position
Studant
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences., GHotb Ravandi Blvd.,Kashan Town
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5545 1898
Email
m.kebriti20@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
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