Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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percentile 85 to 95 in tables of body mass index of children and adolescents
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Intervention groups
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10-session treatment of dialectical behavior therapy once a week. Control group: A group whose members did not receive treatment.
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Main outcome variables
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Emotion regulation; Impulsivity; Depression; Anxiety; executive function; Body mass index; Waist size
General information
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Reason for update
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Reason for general update: End of clinical trial
Specific causes: change in the maximum age of the sample due to the difference in stress levels of students in the first and second high schools, change in the criterion of body mass index due to differences in how the body mass index is calculated in adolescents compared to adults, change in expected onset and end of disease owing to the delay in receiving the code of ethics.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190827044626N1
Registration date:
2020-01-10, 1398/10/20
Registration timing:
retrospective
Last update:
2023-03-27, 1402/01/07
Update count:
1
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Registration date
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2020-01-10, 1398/10/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-02-09, 1397/11/20
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Expected recruitment end date
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2019-12-21, 1398/09/30
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Actual recruitment start date
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2019-02-09, 1397/11/20
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Actual recruitment end date
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2019-12-26, 1398/10/05
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Trial completion date
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2020-10-01, 1399/07/10
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Scientific title
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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
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Public title
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The effect of dialectical behavior therapy on psychological symptoms and Body measurement indices
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
13- 15 years old when participating in the research
85-95 percentile in tables of body mass index of children and adolescents
No concomitant psychological disorders
Lack of concomitant psychological treatment
No eating disorders
No diabetes and thyroid-related disorders
No psychiatric medication
No utilization of drugs that reduce or stimulate the appetite
NO diet
Do not participate in regular exercise programs
Depression score 10 to 29 in Beck Depression Inventory
Anxiety score 8 to 25 in Beck Anxiety Inventory
Exclusion criteria:
Failure to cooperate in completing the questionnaire
Absence of more than two treatment sessions
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Age
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From 13 years old to 15 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
Actual sample size reached:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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40 obese and overweight adolescents are selected by purposive sampling according to inclusion criteria. Then they are divided into two groups of intervention (DBT) and 20-person control by simple randomization
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-07, 1397/10/17
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1397.096
Health conditions studied
1
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Description of health condition studied
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Overweight and obesity
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ICD-10 code
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E66
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ICD-10 code description
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Overweight and obesity
Primary outcomes
1
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Description
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emotion regulation
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Timepoint
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Before the intervention, after the intervention, six months after the intervention
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Method of measurement
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Difficulties in Emotion Regulation Scale
2
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Description
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Impulsivity
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Timepoint
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Before the intervention, after the intervention, six months after the intervention
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Method of measurement
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Barratt Impulsiveness Scale
3
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Description
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Depression
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Timepoint
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Before the intervention, after the intervention, six months after the intervention
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Method of measurement
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Beck Depression Inventory
4
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Description
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Anxiety
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Timepoint
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Before the intervention, after the intervention, six months after the intervention
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Method of measurement
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Beck Anxiety Inventory
5
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Description
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Executive function
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Timepoint
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Before the intervention, after the intervention, six months after the intervention
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Method of measurement
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Wisconsin Card Matching Test
6
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Description
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Body mass index.
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Timepoint
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Before the intervention, after the intervention, six months after the intervention
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Method of measurement
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Weight in kg divided by the square of height in meters
7
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Description
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Waist size
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Timepoint
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Before the intervention, after the intervention, six months after the intervention
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Method of measurement
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Calculate the distance between the smallest area below the ribs and above the iliac spine
Intervention groups
1
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Description
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Intervention group: Dialectical behavior therapy is a 12-session therapy intervention that is performed once a week for 90 minutes, during which 4 skills such as emotion regulation, anxiety tolerance, mindfulness and effective communication are taught to participants. This treatment is based on the Marsha Linehan's protocol designed in 1993.
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Category
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Behavior
2
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Description
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Control group: The control group is the group receiving no treatment.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available