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Comparing the effectiveness of dialectical behavior therapy with unified transdiagnostic therapy on the psychological consequences and emotional eating of patients with emotional disorders and determining the mechanisms of change

Protocol summary

Study aim
The aim of the study is to compare the effectiveness of dialectical behavior therapy with integrated trans-diagnostic therapy on the psychological outcomes and emotional eating of patients with emotional disorders and to analyze the patients' experience of the treatment and the facilitating and inhibiting factors affecting the outcome of the treatment
Design
A controlled, parallel-group, single-blind, randomized, sealed-envelope clinical trial on 26 patients
Settings and conduct
Psychiatry and psychotherapy clinics and clinics or obesity clinics in Tehran
Participants/Inclusion and exclusion criteria
Age range from 18 to 65 years, diagnosis of emotional disorders (depressive disorders-anxiety disorders-obsessive/compulsive disorders based on a structured clinical interview), having emotional eating based on the interview and the score obtained from the emotional eating questionnaire (patient scores) In the emotional eating scale, one standard deviation is higher than the mean (M = 52.62, SD = 18.81), age between 18 and 65 years, having at least a high school diploma
Intervention groups
In the experimental group, 12 sessions of integrated transdiagnostic therapy are performed, and in the control group, 12 sessions of dialectical behavior therapy are performed.
Main outcome variables
Emotion regulation, anxiety intensity, depression intensity, affect control, mindfulness, body mass index, distress tolerance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240705062334N1
Registration date: 2024-08-01, 1403/05/11
Registration timing: prospective

Last update: 2024-08-01, 1403/05/11
Update count: 0
Registration date
2024-08-01, 1403/05/11
Registrant information
Name
Mitra Borji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8861 0118
Email address
mitra.borji@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-11-21, 1403/09/01
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of dialectical behavior therapy with unified transdiagnostic therapy on the psychological consequences and emotional eating of patients with emotional disorders and determining the mechanisms of change
Public title
Effect of psychological therapy on emotional eating
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of emotional disorders Having emotional eating Literacy of at least a diploma
Exclusion criteria:
Suffering from manic states or having psychotic symptoms based on structured clinical interview Having an eating disorder based on a structured clinical interview Having a substance use disorder based on a structured clinical interview There is a level of suicide risk
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 26
Randomization (investigator's opinion)
Randomized
Randomization description
Person with emotional disorder and emotional eating are selected using simple randomization method. The randomization unit is Individual. Through a random table of numbers, which are randomly generated without any pattern or order, the names of the participants will be collected as a set of numbers and the numbers will be used to categorize different groups. Odd numbers are placed in the intervention group and odd numbers in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
First, we create random sequences using web-based randomization.Then, based on the size of the research sample, we prepare a number of envelopes and record each random sequence created on a card, and place the cards in envelopes in order and put them in a box.And according to the order of entry of qualified subjects, we open one of the envelopes and the case group is revealed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Jalal Al Ahmad St., South Amirkabir, South Shayk
City
Tehran
Province
Tehran
Postal code
1461614745
Approval date
2024-06-02, 1403/03/13
Ethics committee reference number
IR.IUMS.REC.1403.207

Health conditions studied

1

Description of health condition studied
Emotional Disorders
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
emotional eating
Timepoint
At the beginning of the study, at the end of the study, 3 months after the end of the study
Method of measurement
Emotional Eating Scale

2

Description
Anxiety intensity
Timepoint
At the beginning of the study, at the end of the study, 3 months after the end of the study
Method of measurement
Beck Anxiety Questionnaire

3

Description
Depression intensity
Timepoint
At the beginning of the study, at the end of the study, 3 months after the end of the study
Method of measurement
Beck Depression Questionnaire

4

Description
Distress Tolerance
Timepoint
At the beginning of the study, at the end of the study, 3 months after the end of the study
Method of measurement
Distress Tolerance Scale

5

Description
Mindfulness
Timepoint
At the beginning of the study, at the end of the study, 3 months after the end of the study
Method of measurement
Southampton mindfulness questionnaire

6

Description
Emotion Regulation
Timepoint
At the beginning of the study, at the end of the study, 3 months after the end of the study
Method of measurement
Emotion regulation difficulty questionnaire

7

Description
Affective control
Timepoint
At the beginning of the study, at the end of the study, 3 months after the end of the study
Method of measurement
Affective control scale

8

Description
Body Mass Index
Timepoint
At the beginning of the study, at the end of the study, 3 months after the end of the study
Method of measurement
Dividing weight (kilograms) by height (meters) to the power of 2

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 12 one-hour sessions of individual therapy will be conducted with the integrated Trans-diagnostic treatment method
Category
Treatment - Other

2

Description
Control group: Control group: 12 one-hour sessions of individual therapy with dialectical behavior therapy will be done
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized and subspecialized psychiatry and clinical psychology clinic
Full name of responsible person
Mina mohsennia
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences, 5th floor of the central headquarters
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2703
Email
info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Mitra Borji
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
mitra.borji@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
mitra borji
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
mitraborji@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
mitra borji
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Teran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
mitra.borji@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
No - There is not 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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