Effectiveness of unified trans diagnostic treatment on shame, self-criticism emotional dysregulation and emotional eating among adolescents with high body mass index ( BMI)
Investigation of the effectiveness of unified protocol transdiagnostic treatment (Adolescents) on shame, self-criticism and difficulties in emotional regulation and emotional eating in adolescents with obesity
Design
The clinical trial consists of two groups of control and intervention in which the sample is randomly divided into two groups and are evaluated in three stages before the intervention, after the intervention, follow-up . The total sample size is 30 . Randomization is by lottery method
Settings and conduct
Sampling from specialized nutrition clinics is done by a nutritionist. Individuals are placed in the appropriate group based on the inclusion and exclusion criteria and then the lottery.
Participants/Inclusion and exclusion criteria
inclusion :
age range between 12 to 18 years; being obese based on Body Mass Index; Absence of a current or lifetime eating disorder (anorexia nervosa, Bulimia nervosa) according to the fifth Diagnostic and statistical manual of mental disorders (DSM-5); no dependency on or abusing substance or alcohol; absence of severe psychiatric disorder(schizophreni, pervasive developmental , bipolar type 1 and 2 , obsessive compulsive disorder , suicidal or homicidal ideation or plan,)
exclusion :
receiving weight-loss medication; candidate of bariatric surgery; inability of the patient to access the medical center; receiving concomitant psychological treatment or 6 months prior to the study; simultaneous use of other psychiatric medication;
Intervention groups
The intervention group is treated for 16 sessions (55 minutes each treatment session) twice a week and receives an unified protocol of trans diagnostic . These sessions consist of 8 main modules. During this time, the control group receives only diet from a nutritionist.
Effectiveness of unified trans diagnostic treatment on shame, self-criticism emotional dysregulation and emotional eating among adolescents with high body mass index ( BMI)
Public title
Effectiveness of unified trans diagnostic treatment on emotional problems among adolescents with high body mass index ( BMI)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age range between 12 to 18 years
being obese based on Body Mass Index
Absence of a current or lifetime eating disorder (anorexia nervosa, Bulimia nervosa) according to the 5 Diagnostic and statistical manual of mental disorders (DSM-5)
no dependency on or abusing substance or alcohol
absence of severe psychiatric disorder(schizophrenia, pervasive developmental , bipolar type 1 and 2 , obsessive compulsive disorder , suicidal or homicidal ideation or plan)
Exclusion criteria:
receiving weight-loss medication
candidate of bariatric surgery
inability of the patient to access the medical centre
receiving concomitant psychological treatment or 6 months prior to the study
simultaneous use of other psychiatric medication
Age
From 12 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
First, the available sample of patients referred to Dr. Farsani nutrition clinics is selected and finally, based on the list of patients, random sampling is done by throwing dice. Numbers 1, 3, 5 were assigned to the patient to the treatment group and numbers 2, 4 and 6 were assigned to the patient to the control group.
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 medical faculty shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Arabi Alley , Daneshjoo St, Velenjak.
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-12-21, 1399/10/01
Ethics committee reference number
IR.SBMU.MSP.REC.1399.488
Health conditions studied
1
Description of health condition studied
OBESITY
ICD-10 code
Z68.54
ICD-10 code description
Body mass index (BMI) pediatric, greater than or equal to 95th percentile for age
Primary outcomes
1
Description
BODY SHAME
Timepoint
Before the intervention, after the intervention (60 days after the first evaluation), 60 days after the end of intervention
Method of measurement
Body image shame scale
2
Description
self-criticism
Timepoint
Before the intervention, after the intervention (60 days after the first evaluation), 60 days after the end of intervention
Method of measurement
Gilbert self criticism scale
3
Description
emotion dysregulation
Timepoint
Before the intervention, after the intervention (60 days after the first evaluation), 60 days after the end of intervention
Method of measurement
difficulties in emotion regulation scale
4
Description
emotional eating
Timepoint
Before the intervention, after the intervention (60 days after the first evaluation), 60 days after the end of intervention
Method of measurement
emotional eating scale of Dutch
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Includes diet plan and psychological intervention. The psychological intervention will use an unified protocol of transdiagnostic for adolescents, which is a 16-session intervention. Each session is 55 minutes. This treatment consists of 8 parts that include motivation for treatment, diagnosis and tracking of emotional experiences, emotional awareness training, cognitive flexibility, emotional avoidance, emotion-driven behaviors, awareness of bodily senses and their tolerance, endogenous exposure to emotions
Category
Treatment - Other
2
Description
Control group: Just get a diet without getting psychological intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farsani nutirition clinic
Full name of responsible person
Gholamreza Mohammadi Farsani
Street address
No. 26, west Zayandehrud Alley, North Shirazi St, Mollasadra.
City
Tehran
Province
Tehran
Postal code
1991613651
Phone
+98 21 8803 8972
Email
mohammadigh53@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Arabi Alley , Daneshjoo St, Velenjak.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 0096
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Abbas Masjedi Arani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti University of Medical Sciences, Arabi Alley , Daneshjoo St, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
doctormasjedi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
parastoo Naimijoo
Position
ph.D candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti University of Medical Sciences, Arabi Alley , Daneshjoo St, Velenjak.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
pnaeimijoo1392@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
parastoo naimijoo
Position
phd candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti University of Medical Sciences, Arabi Alley , Daneshjoo St, Velenjak.
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
pnaeimijoo1392@gmail.com
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
result. tables and treatment protocol
When the data will become available and for how long
from 1400
To whom data/document is available
qualified applicants , medical graduates, specialized fellowship , psychiatrists, clinical and health psychologists, adolescents psychologists , nutritions
Under which criteria data/document could be used
repeated measures of analysis
From where data/document is obtainable
parastoo Naeimijoo( pnaeimijoo1392@gmail)
What processes are involved for a request to access data/document
The applicant must first submit their application by an academic email to the corresponding and then the request will be checked within one week and if approved the data will be sent