The effect of Unified Transdiagnostic Therapy and cognitive Behavioural Therapy On Negative affect, Anexiety, Shame, Self-criticism and Difficulties in Emotional Regulation in Obese children
Evaluation of the effectiveness of integrated meta-diagnostic therapy and cognitive-behavioral therapy on negative emotion, anxiety, shame, self-criticism, emotion regulation difficulties in obese children.
Design
A clinical trial with a control group with parallel groups and without blinding on 51 samples is divided into three groups (two intervention groups and one control group) of 17 randomized people. Simple randomization is used for randomization.The website https://www.Randomization.com is used online for random allocation. Numbered, sealed envelopes are used for allocation concealment.
Settings and conduct
After coordination with schools in Zarrinshahr and Fooladshahr cities of Isfahan, Unified Transdiagnostic Therapy in 8 two-hour sessions for 17 obese children and cognitive-behavioral therapy for 17 other obese children and 17 control group, of course, with The consent of each parent of the children and explaining the purpose of the research is performed. Before and after the treatment, questionnaires are given to the clients to be completed and the control group does not receive any treatment. In this study we didn't have blindness
Participants/Inclusion and exclusion criteria
Inclusion criteria
Age 7- 15
primary education
Diagnosis of obesity by an endocrinologist
Clinical interview and confirm the child's dissatisfaction with being overweight
Exclusion criteria
Reluctance to continue treatment
Intervention groups
ntervention group 1 included overweight and obese children who received Unified Transdiagnostic therapy intervention in 8 sessions.
Intervention group 2 included overweight and obese children who received cognitive behavioral therapy intervention in 8 sessions.
Control group: who do not receive intervention.
Main outcome variables
Negative affect, Anxiety, Shame, Self-criticism and Difficulties in Emotional Regulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171011036722N1
Registration date:2021-12-30, 1400/10/09
Registration timing:retrospective
Last update:2021-12-30, 1400/10/09
Update count:0
Registration date
2021-12-30, 1400/10/09
Registrant information
Name
Amir Sam Kianimoghadam
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9770
Email address
kianimoghadam@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Unified Transdiagnostic Therapy and cognitive Behavioural Therapy On Negative affect, Anexiety, Shame, Self-criticism and Difficulties in Emotional Regulation in Obese children
Public title
The effect of Unified Transdiagnostic Therapy and cognitive Behavioural Therapy On Obese children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight and obesity in children - 7 to 15 years old - Having primary education - Completing the informed consent form based on voluntary participation in the study and not receiving psychological services outside the treatment session by parents - Conducting a clinical interview and confirming the child's dissatisfaction with Overweight
Exclusion criteria:
Having diagnostic criteria for obvious psychiatric disorders based on clinical interview - Parents' dissatisfaction with the child's presence in treatment sessions - History of hospitalization in psychiatric wards - Use of psychiatric drugs - Participation in treatment programs related to research treatment methods during the last six months-Reluctance to continue treatment
Age
From 7 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomized clinical trial in which obese children ranged in age from 7 to 15 years. Sampling is available from schools in Zarrinshahr and Fooladshahr, Isfahan. The sample size was proposed using G power software considering H1 0.4, alpha 0.5, power 0.8 and H0 equal to three sample groups with a volume of 51 people (17 people in each group). Using a simple randomization method with an individual randomization unit, randomization is performed from a computer sequence, which is numbered, sealed, hidden and stored in the center. The website https://www.Randomization.com is used online for random allocation.
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
Working Group of Ethics Committee in Research, School of Medicine, Shahid Beheshti University of Med
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-10-26, 1400/08/04
Ethics committee reference number
IR.SBMU.MSP.REC.1400.521
Health conditions studied
1
Description of health condition studied
Obese children
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Negative affect
Timepoint
Measurement of negative affect variable using a questionnaire before starting treatment and after receiving 8 sessions of treatment
Method of measurement
Abustani Children Negative and Positive Emotion Scale Short Form
2
Description
Emotion Regulation
Timepoint
Measurement of Emotion Regulation variable using a questionnaire before starting treatment and after receiving 8 sessions of treatment
Method of measurement
Shield Child and Adolescent Form Emotion Regulation Checklist
3
Description
Self-Critical
Timepoint
Measurement of Self-Critical variable using a questionnaire before starting treatment and after receiving 8 sessions of treatment
Method of measurement
Thompson and Zarov Self-Critical Inventory
4
Description
Anxiety
Timepoint
Measurement of Anxiety variable using a questionnaire before starting treatment and after receiving 8 sessions of treatment
Method of measurement
Maurice Child and Adolescent Anxiety Inventory
5
Description
shame
Timepoint
Measurement of shame variable using a questionnaire before starting treatment and after receiving 8 sessions of treatment
Method of measurement
Gross et shame Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Integrative Transdiagnostic treatmentSession 1: Familiarity of group members with each other and establishing a therapeutic relationship, familiarity of children and their parents with the research topic and preliminary explanations will be explained to the group members.Session 2: Recognizing Emotions and Orienting Here and Now, Participants are asked to express their positive and negative emotions. ARC Emotional Experience Model Training. The purpose of this training is to be aware of the patterns of individual emotional response and the factors that create and maintain these patterns.Session 3 and 4: Review of the homework of the previous session. Learn to observe emotional experience and react to emotions using mindfulness techniques.Session 5: Reviewing the homework of the previous session will be done at the beginning of the muscle relaxation session for more concentration and self-awareness training. In this session, behaviors affected by emotion and creating inconsistent behaviors and emotional encounters are performed.Session 6: Assign the previous session to review and give feedback. In this session, maladaptive behaviors affected by emotion and their role in the continuation of unhappiness, negative emotions and feelings of shame, are discussed. The role of physical feelings and negative evaluations of one's appearance, the role of others' evaluation in creating excitement and finally the feeling of worry and shame about one's appearance and the stability of these feelings will be discussed.Session 7: Review the homework of the previous session. Introducing a three-dimensional behavioral model to express the common relationship between behavior, emotions, psychological functions and observable behavior. In this way, a model is presented in which a simulation of the interaction between thoughts, behaviors and feelings is explained, and there is an interaction between them.Session 8: Review the homework of the previous session. Participants should be able to express the interrelationships between thoughts and emotions and feelings of shame and notice errors in their perceptions. An overview of treatment is given in this session. Get feedback from participants.Follow-up session: In this session, the general concepts of treatment are reviewed and the participants' therapeutic progress is examined.
Category
Treatment - Other
2
Description
Intervention group: cognitive behavioral therapySession 1: Familiarity of group members with each other and establishing a therapeutic relationship, familiarity of children and their parents with the research topic and preliminary explanations will be explained to the group members.Session 2: In this session, we will teach different feelings and emotions and name them. In order for the subject to know his feelings and emotions better.Session 3: In this session, we ask the subjects about their appearance and how they perceive these physical changes.Session 4: In this session, the topics of the previous session are explained in more detail. Subjects should first express their emotions about their appearance and changes and pay more attention to the thoughts they had after these emotions.Session 5: Review the assignment of the previous session and give feedback to the subjects. In this session, we will teach the possibility of having different ways of thinking with our own way of thinking.Session 6: Review the assignment of the previous session, review the alternative thoughts of dysfunctional thoughts and also review the results of these thoughts. In this session, we should have more emphasis on thoughts and their effect on the body and emotions.Session 7: In this session, the focus is more on the evaluations of others than the appearance of the subjects. To do this, explain to the group members how each person is different and worried about different things.Session 8: Learn how to turn your problems into smaller, more accessible steps. It is important to note that identifying thoughts, emotions, and emotions is the result. And correcting thinking will lead to more positive emotions.Follow-up session: In this session, the general concepts of treatment are reviewed and the participants' therapeutic progress is examined.
Category
Treatment - Other
3
Description
Control group: They do not receive any intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Zarrinshahr and Fooladshahr primary schools
Full name of responsible person
Amirsam kiani moghadam
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2303 1548
Email
as.kianimoghadam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
dr.Amirsam kianimoghadam
Street address
Tehran - Shahid Chamran Highway - Yemen Street - Next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences Postal
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9951
Email
as.kianimghadam@gmailcm
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
Dr.Amirsam Kianimghadam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2303 1548
Email
as.kianimghadam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amirsam Kianimoghadam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2303 1548
Email
as.kianimoghadam@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Sam Kianimoghaddam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tehran - Shahid Chamran Highway - Yemen Street - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2303 1548
Email
as.kianimoghadam@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