Protocol summary

Study aim
Determining the difference in the effectiveness of mentalization-based therapy and dialectical behavior therapy on positive and negative emotions, interpersonal sensitivity, cohesive self-knowledge, and self-critical rumination in individuals with binge eating disorder in Tehran.
Design
60 people with binge eating disorder are selected through purposive sampling and randomly assigned to three groups of 20 people. Pre-test, post-test and follow-up for the three groups are performed, in the qualitative part, data collection, library, data analysis through mixed variance analysis, in the quantitative part, the first group is subjected to (12 sessions, 90 minutes) dialectical behavior therapy protocol and the second group is subjected to 12 sessions, 90 minutes, mentalization-based therapy intervention, and the control group is not subjected to the intervention and after the intervention, the post-test will be performed.
Settings and conduct
After random sampling, questionnaires are completed at the counseling center, dialectical behavior therapy sessions and mentalization-based therapy are conducted for the sample individuals.
Participants/Inclusion and exclusion criteria
Informed consent, having binge eating disorder based on a diagnosis from a clinical psychologist/psychiatrist, being overweight or obese, and not participating in any concurrent psychotherapy
Intervention groups
For the three groups, pre-test, post-test, and follow-up, the second group will receive dialectical therapy, the second group will receive mentalization-based therapy, and the intervention control group will not be conducted.
Main outcome variables
Rate of change in positive and negative emotions, interpersonal sensitivity, cohesive self-knowledge, and self-critical rumination

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260105068563N1
Registration date: 2026-02-11, 1404/11/22
Registration timing: prospective

Last update: 2026-02-11, 1404/11/22
Update count: 0
Registration date
2026-02-11, 1404/11/22
Registrant information
Name
Rayhaneh Alasund
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4406 9062
Email address
gandom.psychology@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-03-18, 1404/12/27
Expected recruitment end date
2026-04-19, 1405/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of mentalization-based therapy and dialectical behavior therapy on positive and negative emotions, interpersonal sensitivity, cohesive self-knowledge, and self-critical rumination in individuals with binge eating disorder (BED) in Tehran.
Public title
Comparing the effectiveness of mentalization-based therapy and dialectical behavior therapy on positive and negative emotions, interpersonal sensitivity, cohesive self-knowledge, and self-critical rumination in individuals with binge eating disorder (BED) in Tehran.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent Involvement of excessive eating disorder based on diagnosis of clinical / clinical psychologist Body mass index ( bmi > 25 - 30 kg ) or obesity ( body mass index > 30 kg ) Age range of 50 - 18 years Lack of participation in any concurrent psychotherapy
Exclusion criteria:
Obesity resulting from physical injuries Lack of desire to end the period Substance abuse ،alcohol abuse Absence of more than two meetings History of interventions in the past month
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
60 % of people with excessive binge eating disorder were selected using purposeful sampling method based on the criteria of inclusion and randomly assigned to each member of the statistical society of a number .then, the numbers are randomly selected and the corresponding members with these numbers were selected as the selection sample of the experimental group and one control group ( 20 people in each 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
Research Ethics Committee ،Islamic Ahvaz University
Street address
Administrative Complex،First Floor،Islamic Azad University، Ahvaz Branch، Farhang Shahr،Golestan Highway،Ahvaz،Iran
City
Ahvaz
Province
Khouzestan
Postal code
6461821920
Approval date
2025-12-20, 1404/09/29
Ethics committee reference number
IR.IAU.AHVAZ.REC.1404.532

Health conditions studied

1

Description of health condition studied
Binge eating disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The score that the subjects had a positive and negative affect on the questionnaire .
Timepoint
En Pre-test 7 days, post-test 7 days, intervention 60 days, follow-up 60 days after the post-test.
Method of measurement
Positive and negative affect questionnaire

2

Description
The score was obtained from interpersonal sensitivity .
Timepoint
Pre-test 7 days, post-test 7 days, intervention 60 days, follow-up 60 days after the post-test.
Method of measurement
Interpersonal sensitivity questionnaire

3

Description
The score was obtained from integrative self - knowledge .
Timepoint
Pre-test 7 days, post-test 7 days, intervention 60 days, follow-up 60 days after the post-test.
Method of measurement
Integrative self - knowledge questionnaire

4

Description
The scores of subjects were obtained critical from questionnaire .
Timepoint
Pre-test 7 days, post-test 7 days, intervention 60 days, follow-up 60 days after the post-test.
Method of measurement
Obtained critical from questionnaire .

Secondary outcomes

empty

Intervention groups

1

Description
intervention group : the first intervention group received 1 - pre - test from the intervention group . 2 - the second phase was divided to the first group of dialectical behavior therapy in 12 sessions of 90 minutes .4 . the fourth stage of intervention will be done after the first group .
Category
Treatment - Other

2

Description
Intervention group: intervention group : the intervention group was taken from the intervention group 2 - the second phase of the intervention group was given 12 sessions of mindfulness - based therapy .3 . the second group was trained .4 - the fourth stage of the study will be done from two groups of intervention after the month .
Category
Treatment - Other

3

Description
Control group: no intervention will be performed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
centre of consultation and psychology of the Otageh Rosan
Full name of responsible person
Rayhaneh Alasvand
Street address
Tehran, Yousef Abad, Fathi Shaghaghi St., Farahani Pour St., 9th St. Farahani Pour St., Fathi Shaghaghi St., Yousef Abad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1433713915
Phone
+98 21 4406 9062
Email
gandom.psychology@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Taghipour Birgani
Street address
First floor office complex، Islamic Azad University of Ahvaz Branch، Farhang Shahr، Golestan Highway، Ahvaz،Iran
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8420
Fax
+98 61 3334 8336
Email
gandom.psychology@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Rayhaneh Alasvand
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Humanities, Islamic Azad University of Ahvaz Branch, Farhang Shahr, Golestan Highway, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
0984144069062
Fax
+98 61 3334 8336
Email
gandom.psychology@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Cobra Kazamein Mougadam
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Humanities, Islamic Azad University of Dezful, Azadegan boulevard, Daneshgah boulevard
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
+98 61 4242 0606
Email
Kazemian174@iau.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Rayhaneh Alasvand
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Humanities, Islamic Azad University of Ahvaz Branch, Farhang Shahr, Golestan Highway, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8420
Fax
+98 61 3334 8336
Email
gandom.psychology@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
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