The effect of dialectical behavioral therapy on emotion regulation, impulsivity, depression, anxiety, executive function, body mass index and waist circumference in overweight and obese adolescent girls
Determining the effectiveness of dialectical behavior therapy on emotion regulation, impulsivity, depression, anxiety, executive function, body mass index, and waist circumference in overweight and obese adolescent girls
Design
This is a randomized controlled trial with two groups of dialectical behavior therapy and control group. 40 obese and overweight adolescents who meet the inclusion criteria will be selected by purposive sampling. Participants in the intervention and control groups are randomly assigned and both groups are grouped according to all known factors. Then the subjects will be replaced in the 20-person dialectical behavior therapy and control groups.
Settings and conduct
The researcher will refer to the Education Department of Kashan with a letter from Kashan University of Medical Sciences. Then some schools will be selected using random sampling. Then, by going to schools, students who are overweight and obese as well as other criteria will be selected through purposeful sampling. Then one of the schools in Kashan will be selected as the research site.
Subjects will then be replaced in the 20-person DBT and control groups. This study is a single blind study and the members of each group will be unaware of the intervention type of the other group
Participants/Inclusion and exclusion criteria
Body mass index more than 25
Intervention groups
10 sessions of once-weekly dialectical behavior therapy. Control group: A group whose members did not receive treatment
Main outcome variables
Emotion regulation; Impulsivity; Depression; Anxiety; executive function; Body mass index; Waist size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190827044626N1
Registration date:2020-01-10, 1398/10/20
Registration timing:retrospective
Last update:2020-01-10, 1398/10/20
Update count:1
Registration date
2020-01-10, 1398/10/20
Registrant information
Name
Maryam Jandaghian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5472 9287
Email address
maryam_jandaghian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dialectical behavioral therapy on emotion regulation, impulsivity, depression, anxiety, executive function, body mass index and waist circumference in overweight and obese adolescent girls
Public title
The effect of dialectical behavior therapy on psychological symptoms and Body measurement indices
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 13 - 18 years when participating in the study
BMI greater than 25
Lack of Simultaneous psychological disorders
Lack of concurrent psychological treatment
No eating disorders
No Diabetes and Thyroid
No use of drugs for mental disorders
No use of medication to reduce appetite or stimulate appetite
Not using a diet
Not participating in regular exercise programs
Depression score of 10 to 29 in Beck Depression Inventory
Anxiety score of 8 to 25 in Beck Anxiety Inventory
Exclusion criteria:
Failure to cooperate in completing the questionnaire
Absence of more than two treatment sessions
Age
From 13 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
Forty obese and overweight adolescents are selected by purposeful sampling. Then, they are randomly divided into two groups of intervention (DBT) and control group of 20 persons.
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 Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences Ethics Committee, Kashan Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
3713979671
Approval date
2019-01-07, 1397/10/17
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.096
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
emotion regulation
Timepoint
Before the intervention, after the intervention, three months after the intervention
Method of measurement
Difficulties in Emotion Regulation Scale
2
Description
Impulsivity
Timepoint
Before the intervention, after the intervention, three months after the intervention
Method of measurement
Barratt Impulsiveness Scale
3
Description
Depression
Timepoint
Before the intervention, after the intervention, three months after the intervention
Method of measurement
Beck Depression Inventory
4
Description
Anxiety
Timepoint
Before the intervention, after the intervention, three months after the intervention
Method of measurement
Beck Anxiety Inventory
5
Description
Executive function
Timepoint
Before the intervention, after the intervention, three months after the intervention
Method of measurement
Wisconsin Card Matching Test
6
Description
Body mass index.
Timepoint
Before the intervention, after the intervention, three months after the intervention
Method of measurement
Weight in kg divided by the square of height in meters
7
Description
Waist size
Timepoint
Before the intervention, after the intervention, three months after the intervention
Method of measurement
Calculate the distance between the smallest area below the ribs and above the iliac spine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dialectical Behavioral Therapy is a 12-session intervention session that lasts 90 minutes once a week during which participants are taught 4 skills: emotion regulation, distress tolerance, mindfulness and interpersonal effectiveness. This treatment is based on the Marsha Linehan protocol, which was designed in 1993.
Category
Behavior
2
Description
Control group: The control group is the group receiving no treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Education Department of Kashan city
Full name of responsible person
Mohammad Hussein Zahedi
Street address
Department of Education, Dr. Ghaznavi St., Kashan
City
Kashan
Province
Isfehan
Postal code
8714687971
Phone
+98 31 5545 4145
Email
mzahedi@gmail.com
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
City
Kashan
Province
Isfehan
Postal code
88715973474
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
Maryam Jandaghian
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5472 9287
Email
maryam_jandaghian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Maryam Jandaghian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5472 9287
Email
maryam_jandaghian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Maryam Jandaghian
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kashan University of Medical Sciences, Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5472 9287
Email
maryam_jandaghain@yahoo.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